Reproductive Endocrinology

SAN ANTONIO — Fertility preservation and/or assisted reproductive technologies do not increase the risk for short-term cancer recurrence in young women with early hormone receptor (HR)-positive breast cancer who pause endocrine therapy to conceive, according to new data from the POSITIVE trial.

“We believe these data are of vital importance for the oncofertility counseling of young breast cancer patients,” Hatem A. Azim Jr., MD, PhD, adjunct professor, School of Medicine and Breast Cancer Center, Monterrey Institute of Technology, Mexico, said in a presentation at the San Antonio Breast Cancer Symposium.

As reported previously by this news organization, the primary results of the POSITIVE trial showed that interrupting endocrine therapy to allow pregnancy does not increase the risk of recurrence at 41 months follow-up. 

Yet, there is concern that use of fertility preservation or assisted reproductive technology methods — especially those that entail the use of hormones — could have harmful effects on patients with HR-positive breast cancers, Dr. Azim explained. 

To investigate, Dr. Azim and colleagues did a secondary analysis of outcomes from the POSITIVE trial, focusing on resumption of menstruation and use of fertility preservation and assisted reproductive technologies. 

Among 516 women evaluated for the menstruation analysis, two thirds were aged 35 and older and a little more than half (53%) reported amenorrhea at enrollment, “which is not surprising,” Dr. Azim said. 

“What is encouraging,” he said, is that 85% of women recovered menses within 6 months and 94% within 12 months of pausing endocrine therapy.

Among 497 evaluable participants who paused endocrine therapy to attempt pregnancy, 368 (74%) became pregnant.

Looking at time to pregnancy, there was a clear association between younger age at enrollment and shorter time to pregnancy. The cumulative incidence of pregnancy at 12 months was 64% in women younger than age 35 years, 54% in those aged 35-39, and 38% in those age 40-42. In a multivariable model, age < 35 was the only factor independently associated with a shorter time to pregnancy. 
 

No Harmful Impact on Breast Cancer Outcomes

Turning to fertility preservation and use of assisted reproductive technologies, roughly half of the women (51%) underwent some form of fertility preservation at breast cancer diagnosis and before trial enrollment, most commonly ovarian stimulation for embryo or oocyte cryopreservation.

After enrollment, 43% of women underwent some form of assisted reproductive technology to attempt pregnancy, most commonly ovarian stimulation for in vitro fertilization (IVF) and cryopreserved embryo transfer.

In the multivariable model, cryopreserved embryo transfer was the only assisted reproductive technology significantly associated with a greater chance of becoming pregnant, more than doubling patients’ odds (odds ratio, 2.4).

“This means that at breast cancer diagnosis, we should consider cryopreservation of embryos for future use if desired,” Dr. Azim said. 

Again, age mattered. Women younger than 35 undergoing assisted reproductive technologies had a 50% higher chance of becoming pregnant compared with peers aged 35-39, and an 84% higher chance than women aged 40-42. 

Importantly, there was no apparent short-term detrimental impact of fertility preservation and/or assisted reproductive technologies on breast cancer outcomes, Dr. Azim reported. At 3 years, the breast cancer-free interval was almost identical between women who underwent ovarian stimulation for cryopreservation and those who did not (9.7% vs 8.7%).

“POSITIVE showed positive results that emphasize the importance of active oncofertility counseling with the patient starting at diagnosis,” said Hee Jeong Kim, MD, PhD, professor, Division of Breast Surgery, Asan Medical Center, Seoul, Republic of Korea, and discussant for the study. 

“These data are reassuring for our young patients with a diagnosis of breast cancer and shows that assisted reproductive technology is an option and is probably safe to do with the caveat that it needs longer follow-up,” added SABCS codirector Carlos Arteaga, MD, director, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas.

Dr. Azim has no relevant disclosures. Dr. Arteaga is a scientific adviser to Novartis, Lilly, Merck, AstraZeneca, Daiichi Sankyo, OrigiMed, Immunomedics, PUMA Biotechnology, TAIHO Oncology, Sanofi, and the Susan G. Komen Foundation. He has received grant support from Pfizer, Lilly, and Takeda. Dr. Kim reports no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Fertility preservation and/or assisted reproductive technologies do not increase the risk for short-term cancer recurrence in young women with early hormone receptor (HR)-positive breast cancer who pause endocrine therapy to conceive, according to new data from the POSITIVE trial.

“We believe these data are of vital importance for the oncofertility counseling of young breast cancer patients,” Hatem A. Azim Jr., MD, PhD, adjunct professor, School of Medicine and Breast Cancer Center, Monterrey Institute of Technology, Mexico, said in a presentation at the San Antonio Breast Cancer Symposium.

As reported previously by this news organization, the primary results of the POSITIVE trial showed that interrupting endocrine therapy to allow pregnancy does not increase the risk of recurrence at 41 months follow-up. 

Yet, there is concern that use of fertility preservation or assisted reproductive technology methods — especially those that entail the use of hormones — could have harmful effects on patients with HR-positive breast cancers, Dr. Azim explained. 

To investigate, Dr. Azim and colleagues did a secondary analysis of outcomes from the POSITIVE trial, focusing on resumption of menstruation and use of fertility preservation and assisted reproductive technologies. 

Among 516 women evaluated for the menstruation analysis, two thirds were aged 35 and older and a little more than half (53%) reported amenorrhea at enrollment, “which is not surprising,” Dr. Azim said. 

“What is encouraging,” he said, is that 85% of women recovered menses within 6 months and 94% within 12 months of pausing endocrine therapy.

Among 497 evaluable participants who paused endocrine therapy to attempt pregnancy, 368 (74%) became pregnant.

Looking at time to pregnancy, there was a clear association between younger age at enrollment and shorter time to pregnancy. The cumulative incidence of pregnancy at 12 months was 64% in women younger than age 35 years, 54% in those aged 35-39, and 38% in those age 40-42. In a multivariable model, age < 35 was the only factor independently associated with a shorter time to pregnancy. 
 

No Harmful Impact on Breast Cancer Outcomes

Turning to fertility preservation and use of assisted reproductive technologies, roughly half of the women (51%) underwent some form of fertility preservation at breast cancer diagnosis and before trial enrollment, most commonly ovarian stimulation for embryo or oocyte cryopreservation.

After enrollment, 43% of women underwent some form of assisted reproductive technology to attempt pregnancy, most commonly ovarian stimulation for in vitro fertilization (IVF) and cryopreserved embryo transfer.

In the multivariable model, cryopreserved embryo transfer was the only assisted reproductive technology significantly associated with a greater chance of becoming pregnant, more than doubling patients’ odds (odds ratio, 2.4).

“This means that at breast cancer diagnosis, we should consider cryopreservation of embryos for future use if desired,” Dr. Azim said. 

Again, age mattered. Women younger than 35 undergoing assisted reproductive technologies had a 50% higher chance of becoming pregnant compared with peers aged 35-39, and an 84% higher chance than women aged 40-42. 

Importantly, there was no apparent short-term detrimental impact of fertility preservation and/or assisted reproductive technologies on breast cancer outcomes, Dr. Azim reported. At 3 years, the breast cancer-free interval was almost identical between women who underwent ovarian stimulation for cryopreservation and those who did not (9.7% vs 8.7%).

“POSITIVE showed positive results that emphasize the importance of active oncofertility counseling with the patient starting at diagnosis,” said Hee Jeong Kim, MD, PhD, professor, Division of Breast Surgery, Asan Medical Center, Seoul, Republic of Korea, and discussant for the study. 

“These data are reassuring for our young patients with a diagnosis of breast cancer and shows that assisted reproductive technology is an option and is probably safe to do with the caveat that it needs longer follow-up,” added SABCS codirector Carlos Arteaga, MD, director, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas.

Dr. Azim has no relevant disclosures. Dr. Arteaga is a scientific adviser to Novartis, Lilly, Merck, AstraZeneca, Daiichi Sankyo, OrigiMed, Immunomedics, PUMA Biotechnology, TAIHO Oncology, Sanofi, and the Susan G. Komen Foundation. He has received grant support from Pfizer, Lilly, and Takeda. Dr. Kim reports no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Fertility preservation and/or assisted reproductive technologies do not increase the risk for short-term cancer recurrence in young women with early hormone receptor (HR)-positive breast cancer who pause endocrine therapy to conceive, according to new data from the POSITIVE trial.

“We believe these data are of vital importance for the oncofertility counseling of young breast cancer patients,” Hatem A. Azim Jr., MD, PhD, adjunct professor, School of Medicine and Breast Cancer Center, Monterrey Institute of Technology, Mexico, said in a presentation at the San Antonio Breast Cancer Symposium.

As reported previously by this news organization, the primary results of the POSITIVE trial showed that interrupting endocrine therapy to allow pregnancy does not increase the risk of recurrence at 41 months follow-up. 

Yet, there is concern that use of fertility preservation or assisted reproductive technology methods — especially those that entail the use of hormones — could have harmful effects on patients with HR-positive breast cancers, Dr. Azim explained. 

To investigate, Dr. Azim and colleagues did a secondary analysis of outcomes from the POSITIVE trial, focusing on resumption of menstruation and use of fertility preservation and assisted reproductive technologies. 

Among 516 women evaluated for the menstruation analysis, two thirds were aged 35 and older and a little more than half (53%) reported amenorrhea at enrollment, “which is not surprising,” Dr. Azim said. 

“What is encouraging,” he said, is that 85% of women recovered menses within 6 months and 94% within 12 months of pausing endocrine therapy.

Among 497 evaluable participants who paused endocrine therapy to attempt pregnancy, 368 (74%) became pregnant.

Looking at time to pregnancy, there was a clear association between younger age at enrollment and shorter time to pregnancy. The cumulative incidence of pregnancy at 12 months was 64% in women younger than age 35 years, 54% in those aged 35-39, and 38% in those age 40-42. In a multivariable model, age < 35 was the only factor independently associated with a shorter time to pregnancy. 
 

No Harmful Impact on Breast Cancer Outcomes

Turning to fertility preservation and use of assisted reproductive technologies, roughly half of the women (51%) underwent some form of fertility preservation at breast cancer diagnosis and before trial enrollment, most commonly ovarian stimulation for embryo or oocyte cryopreservation.

After enrollment, 43% of women underwent some form of assisted reproductive technology to attempt pregnancy, most commonly ovarian stimulation for in vitro fertilization (IVF) and cryopreserved embryo transfer.

In the multivariable model, cryopreserved embryo transfer was the only assisted reproductive technology significantly associated with a greater chance of becoming pregnant, more than doubling patients’ odds (odds ratio, 2.4).

“This means that at breast cancer diagnosis, we should consider cryopreservation of embryos for future use if desired,” Dr. Azim said. 

Again, age mattered. Women younger than 35 undergoing assisted reproductive technologies had a 50% higher chance of becoming pregnant compared with peers aged 35-39, and an 84% higher chance than women aged 40-42. 

Importantly, there was no apparent short-term detrimental impact of fertility preservation and/or assisted reproductive technologies on breast cancer outcomes, Dr. Azim reported. At 3 years, the breast cancer-free interval was almost identical between women who underwent ovarian stimulation for cryopreservation and those who did not (9.7% vs 8.7%).

“POSITIVE showed positive results that emphasize the importance of active oncofertility counseling with the patient starting at diagnosis,” said Hee Jeong Kim, MD, PhD, professor, Division of Breast Surgery, Asan Medical Center, Seoul, Republic of Korea, and discussant for the study. 

“These data are reassuring for our young patients with a diagnosis of breast cancer and shows that assisted reproductive technology is an option and is probably safe to do with the caveat that it needs longer follow-up,” added SABCS codirector Carlos Arteaga, MD, director, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas.

Dr. Azim has no relevant disclosures. Dr. Arteaga is a scientific adviser to Novartis, Lilly, Merck, AstraZeneca, Daiichi Sankyo, OrigiMed, Immunomedics, PUMA Biotechnology, TAIHO Oncology, Sanofi, and the Susan G. Komen Foundation. He has received grant support from Pfizer, Lilly, and Takeda. Dr. Kim reports no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

Infertility affects approximately one in six couples worldwide. More than half the time, it is the man’s low sperm quality that is to blame. Over the last three decades, sperm quality seems to have declined for no clearly identifiable reason. Theories are running rampant without anyone having the proof to back them up. 
 

Potential Causes 

The environment, lifestyle, excess weight or obesity, smoking, alcohol consumption, and psychological stress have all been alternately offered up as potential causes, following low-quality epidemiological studies. Cellphones are not exempt from this list, due to their emission of high-frequency (800-2200 MHz) electromagnetic waves that can be absorbed by the body. 

Clinical trials conducted in rats or mice suggest that these waves can affect sperm quality and lead to histological changes to the testicles, bearing in mind that the conditions met in these trials are very far from our day-to-day exposure to electromagnetic waves, mostly via our cellphones. 

The same observation can be made about experiments conducted on human sperm in vitro, but changes to the latter caused by electromagnetic waves leave doubts. Observational studies are rare, carried out in small cohorts, and marred by largely conflicting results. Publication bias plays a major role, just as much as the abundance of potential confounding factors does. 
 

Swiss Observational Study 

An observational study carried out in Switzerland had the benefit of involving a large cohort of 2886 young men who were representative of the general population. The participants completed an online questionnaire describing their relationship with their cellphone in detail and in qualitative and quantitative terms. 

The study was launched in 2005, before cellphone use became so widespread, and this timeline was considered when looking for a link between cellphone exposure and sperm quality. In addition, multiple adjustments were made in the multivariate analyses to account for as many potential confounding factors as possible. 

The participants, aged between 18 and 22 years, were recruited during a 3-day period to assess their suitability for military service. Each year, this cohort makes up 97% of the male population in Switzerland in this age range, with the remaining 3% being excluded from the selection process due to disability or chronic illness. 

Regardless of the review board’s decision, subjects wishing to take part in the study were given a detailed description of what it involved, a consent form, and two questionnaires. The first focused on the individual directly, asking questions about his health and lifestyle. The second, intended for his parents, dealt with the period before conception. 

This recruitment, which took place between September 2005 and November 2018, involved the researchers contacting 106,924 men. Ultimately, only 5.3% of subjects contacted returned the completed documentation. In the end, the study involved 2886 participants (3.1%) who provided all the necessary information, especially the laboratory testing (including a sperm analysis) needed to meet the study objectives. The number of hours spent on a smartphone and how it was used were routinely considered, as was sperm quality (volume, concentration, and total sperm count, as well as sperm mobility and morphology). 
 

Significant Associations 

A data analysis using an adjusted linear model revealed a significant association between frequent phone use (> 20 times per day) and lower sperm concentration (in mL) (adjusted β: -0.152, 95% CI -0.316 to 0.011). The same was found for their total concentration in ejaculate (adjusted β: -0.271, 95% CI -0.515 to -0.027). 

An adjusted logistic regression analysis estimated that the risk for subnormal male fertility levels, as determined by the World Health Organization (WHO), was increased by at most 30%, when referring to the concentration of sperm per mL (21% in terms of total concentration). This inverse link was shown to be more pronounced during the first phase of the study (2005-2007), compared with the other two phases (2008-2011 and 2012-2018). Yet no links involving sperm mobility or morphology were found, and carrying a cellphone in a trouser pocket had no impact on the results. 

This study certainly involves a large cohort of nearly 3000 young men. It is, nonetheless, retrospective, and its methodology, despite being better than that of previous studies, is still open to criticism. Its results can only fuel hypotheses, nothing more. Only prospective cohort studies will allow conclusions to be drawn and, in the meantime, no causal link can be found between exposure to the high-frequency electromagnetic waves emitted by cellphones and the risk of infertility. 
 

This article was translated from JIM, which is part of the Medscape professional network. A version of this article appeared on Medscape.com.

Infertility affects approximately one in six couples worldwide. More than half the time, it is the man’s low sperm quality that is to blame. Over the last three decades, sperm quality seems to have declined for no clearly identifiable reason. Theories are running rampant without anyone having the proof to back them up. 
 

Potential Causes 

The environment, lifestyle, excess weight or obesity, smoking, alcohol consumption, and psychological stress have all been alternately offered up as potential causes, following low-quality epidemiological studies. Cellphones are not exempt from this list, due to their emission of high-frequency (800-2200 MHz) electromagnetic waves that can be absorbed by the body. 

Clinical trials conducted in rats or mice suggest that these waves can affect sperm quality and lead to histological changes to the testicles, bearing in mind that the conditions met in these trials are very far from our day-to-day exposure to electromagnetic waves, mostly via our cellphones. 

The same observation can be made about experiments conducted on human sperm in vitro, but changes to the latter caused by electromagnetic waves leave doubts. Observational studies are rare, carried out in small cohorts, and marred by largely conflicting results. Publication bias plays a major role, just as much as the abundance of potential confounding factors does. 
 

Swiss Observational Study 

An observational study carried out in Switzerland had the benefit of involving a large cohort of 2886 young men who were representative of the general population. The participants completed an online questionnaire describing their relationship with their cellphone in detail and in qualitative and quantitative terms. 

The study was launched in 2005, before cellphone use became so widespread, and this timeline was considered when looking for a link between cellphone exposure and sperm quality. In addition, multiple adjustments were made in the multivariate analyses to account for as many potential confounding factors as possible. 

The participants, aged between 18 and 22 years, were recruited during a 3-day period to assess their suitability for military service. Each year, this cohort makes up 97% of the male population in Switzerland in this age range, with the remaining 3% being excluded from the selection process due to disability or chronic illness. 

Regardless of the review board’s decision, subjects wishing to take part in the study were given a detailed description of what it involved, a consent form, and two questionnaires. The first focused on the individual directly, asking questions about his health and lifestyle. The second, intended for his parents, dealt with the period before conception. 

This recruitment, which took place between September 2005 and November 2018, involved the researchers contacting 106,924 men. Ultimately, only 5.3% of subjects contacted returned the completed documentation. In the end, the study involved 2886 participants (3.1%) who provided all the necessary information, especially the laboratory testing (including a sperm analysis) needed to meet the study objectives. The number of hours spent on a smartphone and how it was used were routinely considered, as was sperm quality (volume, concentration, and total sperm count, as well as sperm mobility and morphology). 
 

Significant Associations 

A data analysis using an adjusted linear model revealed a significant association between frequent phone use (> 20 times per day) and lower sperm concentration (in mL) (adjusted β: -0.152, 95% CI -0.316 to 0.011). The same was found for their total concentration in ejaculate (adjusted β: -0.271, 95% CI -0.515 to -0.027). 

An adjusted logistic regression analysis estimated that the risk for subnormal male fertility levels, as determined by the World Health Organization (WHO), was increased by at most 30%, when referring to the concentration of sperm per mL (21% in terms of total concentration). This inverse link was shown to be more pronounced during the first phase of the study (2005-2007), compared with the other two phases (2008-2011 and 2012-2018). Yet no links involving sperm mobility or morphology were found, and carrying a cellphone in a trouser pocket had no impact on the results. 

This study certainly involves a large cohort of nearly 3000 young men. It is, nonetheless, retrospective, and its methodology, despite being better than that of previous studies, is still open to criticism. Its results can only fuel hypotheses, nothing more. Only prospective cohort studies will allow conclusions to be drawn and, in the meantime, no causal link can be found between exposure to the high-frequency electromagnetic waves emitted by cellphones and the risk of infertility. 
 

This article was translated from JIM, which is part of the Medscape professional network. A version of this article appeared on Medscape.com.

Infertility affects approximately one in six couples worldwide. More than half the time, it is the man’s low sperm quality that is to blame. Over the last three decades, sperm quality seems to have declined for no clearly identifiable reason. Theories are running rampant without anyone having the proof to back them up. 
 

Potential Causes 

The environment, lifestyle, excess weight or obesity, smoking, alcohol consumption, and psychological stress have all been alternately offered up as potential causes, following low-quality epidemiological studies. Cellphones are not exempt from this list, due to their emission of high-frequency (800-2200 MHz) electromagnetic waves that can be absorbed by the body. 

Clinical trials conducted in rats or mice suggest that these waves can affect sperm quality and lead to histological changes to the testicles, bearing in mind that the conditions met in these trials are very far from our day-to-day exposure to electromagnetic waves, mostly via our cellphones. 

The same observation can be made about experiments conducted on human sperm in vitro, but changes to the latter caused by electromagnetic waves leave doubts. Observational studies are rare, carried out in small cohorts, and marred by largely conflicting results. Publication bias plays a major role, just as much as the abundance of potential confounding factors does. 
 

Swiss Observational Study 

An observational study carried out in Switzerland had the benefit of involving a large cohort of 2886 young men who were representative of the general population. The participants completed an online questionnaire describing their relationship with their cellphone in detail and in qualitative and quantitative terms. 

The study was launched in 2005, before cellphone use became so widespread, and this timeline was considered when looking for a link between cellphone exposure and sperm quality. In addition, multiple adjustments were made in the multivariate analyses to account for as many potential confounding factors as possible. 

The participants, aged between 18 and 22 years, were recruited during a 3-day period to assess their suitability for military service. Each year, this cohort makes up 97% of the male population in Switzerland in this age range, with the remaining 3% being excluded from the selection process due to disability or chronic illness. 

Regardless of the review board’s decision, subjects wishing to take part in the study were given a detailed description of what it involved, a consent form, and two questionnaires. The first focused on the individual directly, asking questions about his health and lifestyle. The second, intended for his parents, dealt with the period before conception. 

This recruitment, which took place between September 2005 and November 2018, involved the researchers contacting 106,924 men. Ultimately, only 5.3% of subjects contacted returned the completed documentation. In the end, the study involved 2886 participants (3.1%) who provided all the necessary information, especially the laboratory testing (including a sperm analysis) needed to meet the study objectives. The number of hours spent on a smartphone and how it was used were routinely considered, as was sperm quality (volume, concentration, and total sperm count, as well as sperm mobility and morphology). 
 

Significant Associations 

A data analysis using an adjusted linear model revealed a significant association between frequent phone use (> 20 times per day) and lower sperm concentration (in mL) (adjusted β: -0.152, 95% CI -0.316 to 0.011). The same was found for their total concentration in ejaculate (adjusted β: -0.271, 95% CI -0.515 to -0.027). 

An adjusted logistic regression analysis estimated that the risk for subnormal male fertility levels, as determined by the World Health Organization (WHO), was increased by at most 30%, when referring to the concentration of sperm per mL (21% in terms of total concentration). This inverse link was shown to be more pronounced during the first phase of the study (2005-2007), compared with the other two phases (2008-2011 and 2012-2018). Yet no links involving sperm mobility or morphology were found, and carrying a cellphone in a trouser pocket had no impact on the results. 

This study certainly involves a large cohort of nearly 3000 young men. It is, nonetheless, retrospective, and its methodology, despite being better than that of previous studies, is still open to criticism. Its results can only fuel hypotheses, nothing more. Only prospective cohort studies will allow conclusions to be drawn and, in the meantime, no causal link can be found between exposure to the high-frequency electromagnetic waves emitted by cellphones and the risk of infertility. 
 

This article was translated from JIM, which is part of the Medscape professional network. A version of this article appeared on Medscape.com.

Women with bipolar disorder were three times more likely than were healthy controls to experience polycystic ovarian syndrome, based on data from nearly 250 individuals.

Previous studies suggest that the prevalence of polycystic ovarian syndrome (PCOS) is higher in bipolar disorder (BD) patients compared with individuals not diagnosed with BD, wrote Jieyu Liu, PhD, of the Second Xiangya Hospital of Central South University, Hunan, China, and colleagues.

However, studies have been limited to drug-treated BD patients, and data on the effects of BD on the development of PCOS are limited, they said. Data from previous studies also indicate that serum testosterone levels, serum androstenedione levels, and polycystic ovarian morphology (PCOM) are increased in BD patients compared with women without BD.

In a study published in the Journal of Affective Disorders, the researchers recruited 72 BD patients on long-term medication, 72 drug-naive patients, and 98 healthy controls between March 2022 and November 2022.

PCOM was assessed using ≥ 8 MHz transvaginal transducers to determine the number of follicles and ovarian volume. PCOS was then defined using the Rotterdam criteria, in which patients met two of three qualifications: oligoovulation or anovulation; hyperandrogenemia; or PCOM (excluding other endocrine diseases).

In a multivariate analysis, drug-naive women with BD had significantly higher rates of PCOS compared with healthy controls (odds ratio 3.02). The drug-naive BD patients also had a greater prevalence of oligoamenorrhea compared with healthy controls (36.36% vs. 12.12%) and higher levels of anti-mullerian hormone, luteinizing hormone, and follicle stimulating hormone compared to the controls.

A further regression analysis showed that those on long-term valproate treatment had the highest risk (OR 3.89) and the prevalence of PCOS was significantly higher among patients treated with valproate compared with drug-naive patients (53.3% vs. 30.6%). Younger age and the presence of insulin resistance also were associated with increased risk of PCOS (OR 0.37 and OR 1.73, respectively).

“Unexpectedly, no significant differences in serum androgen levels, including TT, FAI, androstenedione, and [dehydroepiandrosterone sulfate] levels, were observed between drug-naive BD patients and the HCs,” the researchers wrote in their discussion. This difference may stem from multiple causes including demographic variables, inclusion of PCOM as a diagnostic criterion, and the impact of genetic and environmental factors, they said.

The findings were limited by several factors including the small study population, which prevented conclusions of causality and comparison of the effects of different mood stabilizers on PCOS, the researchers noted. Other limitations included the relatively homogeneous population from a single region in China, and the inability to account for the effects of diet and lifestyle.

More research is needed to explore the impact of mediations, but the results suggest that BD patients are susceptible to PCOS; therefore, they should evaluate their reproductive health before starting any medication, and review reproductive health regularly, the researchers concluded.

The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

Women with bipolar disorder were three times more likely than were healthy controls to experience polycystic ovarian syndrome, based on data from nearly 250 individuals.

Previous studies suggest that the prevalence of polycystic ovarian syndrome (PCOS) is higher in bipolar disorder (BD) patients compared with individuals not diagnosed with BD, wrote Jieyu Liu, PhD, of the Second Xiangya Hospital of Central South University, Hunan, China, and colleagues.

However, studies have been limited to drug-treated BD patients, and data on the effects of BD on the development of PCOS are limited, they said. Data from previous studies also indicate that serum testosterone levels, serum androstenedione levels, and polycystic ovarian morphology (PCOM) are increased in BD patients compared with women without BD.

In a study published in the Journal of Affective Disorders, the researchers recruited 72 BD patients on long-term medication, 72 drug-naive patients, and 98 healthy controls between March 2022 and November 2022.

PCOM was assessed using ≥ 8 MHz transvaginal transducers to determine the number of follicles and ovarian volume. PCOS was then defined using the Rotterdam criteria, in which patients met two of three qualifications: oligoovulation or anovulation; hyperandrogenemia; or PCOM (excluding other endocrine diseases).

In a multivariate analysis, drug-naive women with BD had significantly higher rates of PCOS compared with healthy controls (odds ratio 3.02). The drug-naive BD patients also had a greater prevalence of oligoamenorrhea compared with healthy controls (36.36% vs. 12.12%) and higher levels of anti-mullerian hormone, luteinizing hormone, and follicle stimulating hormone compared to the controls.

A further regression analysis showed that those on long-term valproate treatment had the highest risk (OR 3.89) and the prevalence of PCOS was significantly higher among patients treated with valproate compared with drug-naive patients (53.3% vs. 30.6%). Younger age and the presence of insulin resistance also were associated with increased risk of PCOS (OR 0.37 and OR 1.73, respectively).

“Unexpectedly, no significant differences in serum androgen levels, including TT, FAI, androstenedione, and [dehydroepiandrosterone sulfate] levels, were observed between drug-naive BD patients and the HCs,” the researchers wrote in their discussion. This difference may stem from multiple causes including demographic variables, inclusion of PCOM as a diagnostic criterion, and the impact of genetic and environmental factors, they said.

The findings were limited by several factors including the small study population, which prevented conclusions of causality and comparison of the effects of different mood stabilizers on PCOS, the researchers noted. Other limitations included the relatively homogeneous population from a single region in China, and the inability to account for the effects of diet and lifestyle.

More research is needed to explore the impact of mediations, but the results suggest that BD patients are susceptible to PCOS; therefore, they should evaluate their reproductive health before starting any medication, and review reproductive health regularly, the researchers concluded.

The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

Women with bipolar disorder were three times more likely than were healthy controls to experience polycystic ovarian syndrome, based on data from nearly 250 individuals.

Previous studies suggest that the prevalence of polycystic ovarian syndrome (PCOS) is higher in bipolar disorder (BD) patients compared with individuals not diagnosed with BD, wrote Jieyu Liu, PhD, of the Second Xiangya Hospital of Central South University, Hunan, China, and colleagues.

However, studies have been limited to drug-treated BD patients, and data on the effects of BD on the development of PCOS are limited, they said. Data from previous studies also indicate that serum testosterone levels, serum androstenedione levels, and polycystic ovarian morphology (PCOM) are increased in BD patients compared with women without BD.

In a study published in the Journal of Affective Disorders, the researchers recruited 72 BD patients on long-term medication, 72 drug-naive patients, and 98 healthy controls between March 2022 and November 2022.

PCOM was assessed using ≥ 8 MHz transvaginal transducers to determine the number of follicles and ovarian volume. PCOS was then defined using the Rotterdam criteria, in which patients met two of three qualifications: oligoovulation or anovulation; hyperandrogenemia; or PCOM (excluding other endocrine diseases).

In a multivariate analysis, drug-naive women with BD had significantly higher rates of PCOS compared with healthy controls (odds ratio 3.02). The drug-naive BD patients also had a greater prevalence of oligoamenorrhea compared with healthy controls (36.36% vs. 12.12%) and higher levels of anti-mullerian hormone, luteinizing hormone, and follicle stimulating hormone compared to the controls.

A further regression analysis showed that those on long-term valproate treatment had the highest risk (OR 3.89) and the prevalence of PCOS was significantly higher among patients treated with valproate compared with drug-naive patients (53.3% vs. 30.6%). Younger age and the presence of insulin resistance also were associated with increased risk of PCOS (OR 0.37 and OR 1.73, respectively).

“Unexpectedly, no significant differences in serum androgen levels, including TT, FAI, androstenedione, and [dehydroepiandrosterone sulfate] levels, were observed between drug-naive BD patients and the HCs,” the researchers wrote in their discussion. This difference may stem from multiple causes including demographic variables, inclusion of PCOM as a diagnostic criterion, and the impact of genetic and environmental factors, they said.

The findings were limited by several factors including the small study population, which prevented conclusions of causality and comparison of the effects of different mood stabilizers on PCOS, the researchers noted. Other limitations included the relatively homogeneous population from a single region in China, and the inability to account for the effects of diet and lifestyle.

More research is needed to explore the impact of mediations, but the results suggest that BD patients are susceptible to PCOS; therefore, they should evaluate their reproductive health before starting any medication, and review reproductive health regularly, the researchers concluded.

The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

Artificial intelligence can accurately predict the optimal retrieval date in fertility treatment cycles, according to preliminary research presented at the annual meeting of the American Society for Reproductive Medicine. According to the researchers, such an algorithm is needed due to the increased demand for fertility treatments, as well as the high day-to-day variability in lab workload.

According to the study investigators, predicting retrieval dates in advance for ongoing cycles is of major importance for both patients and clinicians.

“The population requiring fertility treatments, including genetic testing and fertility preservation, has massively increased, and this causes many more cycles and a high day-to-day variability in IVF activity, especially in the lab workload,” said Rohi Hourvitz, MBA, from FertilAI, an Israeli health care company focused on developing technologies that improve fertility treatments.

“We also need to accommodate and reschedule for non-working days, which causes a big issue with managing the workload in many clinics around the world,” added Mr. Hourvitz, who presented the research highlighting AI’s growing role in reproductive medicine.

In addition, AI has recently emerged as an effective tool for assisting in clinical decision-making in assisted reproductive technology, prompting further research in this space, he said.

The new study used a dataset of 9,550 predictable antagonist cycles (defined as having all necessary data) gathered from one lab with over 50 physicians between August 2018 and October 2022. The data were split into two subsets: one for training the AI model and the other for prospective testing. 

To train and test the AI model, data from nearly 6,000 predictable antagonist cycles were used. Key factors used for each cycle included estrogen levels, mean follicle size, primary follicle size, and various patient demographics. Other features were considered, but Mr. Hourvitz noted that primary follicle size influenced the algorithm most, “because that is what most of us use when we want to trigger.”

Mr. Hourvitz explained that these patient data were run through an algorithm that produced a graph predicting the most probable date for a cycle retrieval.

“We could accurately predict when those ‘peak days’ were going to be happening in the clinic, and we could also give a pretty good estimate on how many cycles you’re going to have every day,” Mr. Hourvitz said, explaining that this information could help clinics more efficiently allocate resources and manage patients.

According to Mr. Hourvitz, the predictions derived from this study could improve various aspects of fertility treatments and related procedures, including better staff planning and caseload management in IVF labs, as well as higher-quality eggs at retrieval. Patients would have a clearer timeline for their treatment cycles.   

Nikica Zaninovic, PhD, MS, director of the embryology lab at Weill Cornell Medical College, New York City, cautioned that the new findings are not yet ready for clinical application but emphasized the importance of more AI research focusing on the quality of oocytes, not only embryos.

“We’re so focused on the end of the process: the embryo,” Dr. Zaninovic, who was not involved in the research, said in an interview. “I think the focus should be on the beginning – the quality of eggs and sperm, not just the quantity – because that’s what the embryos will depend on.”

He noted the increasing numbers of young women in the United States undergoing egg freezing.

“Cornell is the largest academic IVF center in the United States; 20%-30% of all of the patients that we treat are actually freezing their eggs,” he said. “It’s a huge population.”

“When they come to us, they ask how many eggs they’ll need to guarantee one or two children in the future,” Dr. Zaninovic continued. “We don’t have that answer, so we always tell them [we’ll retrieve] as many as we can. That’s not the answer; we need to be more precise. We’re still lacking these tools, and I think that’s where the research will go.”

The study was funded by FertilAI. Mr. Hourvitz is a shareholder and CEO of FertilAI. Dr. Zaninovic is president of the AI Fertility Society.

A version of this article appeared on Medscape.com.

Artificial intelligence can accurately predict the optimal retrieval date in fertility treatment cycles, according to preliminary research presented at the annual meeting of the American Society for Reproductive Medicine. According to the researchers, such an algorithm is needed due to the increased demand for fertility treatments, as well as the high day-to-day variability in lab workload.

According to the study investigators, predicting retrieval dates in advance for ongoing cycles is of major importance for both patients and clinicians.

“The population requiring fertility treatments, including genetic testing and fertility preservation, has massively increased, and this causes many more cycles and a high day-to-day variability in IVF activity, especially in the lab workload,” said Rohi Hourvitz, MBA, from FertilAI, an Israeli health care company focused on developing technologies that improve fertility treatments.

“We also need to accommodate and reschedule for non-working days, which causes a big issue with managing the workload in many clinics around the world,” added Mr. Hourvitz, who presented the research highlighting AI’s growing role in reproductive medicine.

In addition, AI has recently emerged as an effective tool for assisting in clinical decision-making in assisted reproductive technology, prompting further research in this space, he said.

The new study used a dataset of 9,550 predictable antagonist cycles (defined as having all necessary data) gathered from one lab with over 50 physicians between August 2018 and October 2022. The data were split into two subsets: one for training the AI model and the other for prospective testing. 

To train and test the AI model, data from nearly 6,000 predictable antagonist cycles were used. Key factors used for each cycle included estrogen levels, mean follicle size, primary follicle size, and various patient demographics. Other features were considered, but Mr. Hourvitz noted that primary follicle size influenced the algorithm most, “because that is what most of us use when we want to trigger.”

Mr. Hourvitz explained that these patient data were run through an algorithm that produced a graph predicting the most probable date for a cycle retrieval.

“We could accurately predict when those ‘peak days’ were going to be happening in the clinic, and we could also give a pretty good estimate on how many cycles you’re going to have every day,” Mr. Hourvitz said, explaining that this information could help clinics more efficiently allocate resources and manage patients.

According to Mr. Hourvitz, the predictions derived from this study could improve various aspects of fertility treatments and related procedures, including better staff planning and caseload management in IVF labs, as well as higher-quality eggs at retrieval. Patients would have a clearer timeline for their treatment cycles.   

Nikica Zaninovic, PhD, MS, director of the embryology lab at Weill Cornell Medical College, New York City, cautioned that the new findings are not yet ready for clinical application but emphasized the importance of more AI research focusing on the quality of oocytes, not only embryos.

“We’re so focused on the end of the process: the embryo,” Dr. Zaninovic, who was not involved in the research, said in an interview. “I think the focus should be on the beginning – the quality of eggs and sperm, not just the quantity – because that’s what the embryos will depend on.”

He noted the increasing numbers of young women in the United States undergoing egg freezing.

“Cornell is the largest academic IVF center in the United States; 20%-30% of all of the patients that we treat are actually freezing their eggs,” he said. “It’s a huge population.”

“When they come to us, they ask how many eggs they’ll need to guarantee one or two children in the future,” Dr. Zaninovic continued. “We don’t have that answer, so we always tell them [we’ll retrieve] as many as we can. That’s not the answer; we need to be more precise. We’re still lacking these tools, and I think that’s where the research will go.”

The study was funded by FertilAI. Mr. Hourvitz is a shareholder and CEO of FertilAI. Dr. Zaninovic is president of the AI Fertility Society.

A version of this article appeared on Medscape.com.

Artificial intelligence can accurately predict the optimal retrieval date in fertility treatment cycles, according to preliminary research presented at the annual meeting of the American Society for Reproductive Medicine. According to the researchers, such an algorithm is needed due to the increased demand for fertility treatments, as well as the high day-to-day variability in lab workload.

According to the study investigators, predicting retrieval dates in advance for ongoing cycles is of major importance for both patients and clinicians.

“The population requiring fertility treatments, including genetic testing and fertility preservation, has massively increased, and this causes many more cycles and a high day-to-day variability in IVF activity, especially in the lab workload,” said Rohi Hourvitz, MBA, from FertilAI, an Israeli health care company focused on developing technologies that improve fertility treatments.

“We also need to accommodate and reschedule for non-working days, which causes a big issue with managing the workload in many clinics around the world,” added Mr. Hourvitz, who presented the research highlighting AI’s growing role in reproductive medicine.

In addition, AI has recently emerged as an effective tool for assisting in clinical decision-making in assisted reproductive technology, prompting further research in this space, he said.

The new study used a dataset of 9,550 predictable antagonist cycles (defined as having all necessary data) gathered from one lab with over 50 physicians between August 2018 and October 2022. The data were split into two subsets: one for training the AI model and the other for prospective testing. 

To train and test the AI model, data from nearly 6,000 predictable antagonist cycles were used. Key factors used for each cycle included estrogen levels, mean follicle size, primary follicle size, and various patient demographics. Other features were considered, but Mr. Hourvitz noted that primary follicle size influenced the algorithm most, “because that is what most of us use when we want to trigger.”

Mr. Hourvitz explained that these patient data were run through an algorithm that produced a graph predicting the most probable date for a cycle retrieval.

“We could accurately predict when those ‘peak days’ were going to be happening in the clinic, and we could also give a pretty good estimate on how many cycles you’re going to have every day,” Mr. Hourvitz said, explaining that this information could help clinics more efficiently allocate resources and manage patients.

According to Mr. Hourvitz, the predictions derived from this study could improve various aspects of fertility treatments and related procedures, including better staff planning and caseload management in IVF labs, as well as higher-quality eggs at retrieval. Patients would have a clearer timeline for their treatment cycles.   

Nikica Zaninovic, PhD, MS, director of the embryology lab at Weill Cornell Medical College, New York City, cautioned that the new findings are not yet ready for clinical application but emphasized the importance of more AI research focusing on the quality of oocytes, not only embryos.

“We’re so focused on the end of the process: the embryo,” Dr. Zaninovic, who was not involved in the research, said in an interview. “I think the focus should be on the beginning – the quality of eggs and sperm, not just the quantity – because that’s what the embryos will depend on.”

He noted the increasing numbers of young women in the United States undergoing egg freezing.

“Cornell is the largest academic IVF center in the United States; 20%-30% of all of the patients that we treat are actually freezing their eggs,” he said. “It’s a huge population.”

“When they come to us, they ask how many eggs they’ll need to guarantee one or two children in the future,” Dr. Zaninovic continued. “We don’t have that answer, so we always tell them [we’ll retrieve] as many as we can. That’s not the answer; we need to be more precise. We’re still lacking these tools, and I think that’s where the research will go.”

The study was funded by FertilAI. Mr. Hourvitz is a shareholder and CEO of FertilAI. Dr. Zaninovic is president of the AI Fertility Society.

A version of this article appeared on Medscape.com.

Adverse events related to the use of embryo transfer catheters (ETCs) may be underreported to the U.S. Food and Drug Administration, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.

ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.

“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”

Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.

Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.

For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”

Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.

Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.

The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.

“That finding stood out,” Dr. Madison said.

Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.

Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.

“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”

A version of this article first appeared on Medscape.com.

Adverse events related to the use of embryo transfer catheters (ETCs) may be underreported to the U.S. Food and Drug Administration, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.

ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.

“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”

Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.

Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.

For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”

Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.

Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.

The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.

“That finding stood out,” Dr. Madison said.

Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.

Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.

“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”

A version of this article first appeared on Medscape.com.

Adverse events related to the use of embryo transfer catheters (ETCs) may be underreported to the U.S. Food and Drug Administration, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.

ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.

“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”

Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.

Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.

For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”

Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.

Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.

The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.

“That finding stood out,” Dr. Madison said.

Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.

Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.

“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”

A version of this article first appeared on Medscape.com.

Commercial sperm banks in the United States lack racially and ethnically diverse donors, potentially limiting family-planning options for patients in traditionally underserved populations, according to a study presented at the American Society for Reproductive Medicine’s 2023 meeting.

“This really highlights the need to identify barriers to increase recruitment of these donors so that we can support family-building for all populations,” said Lauren Gibbs, MD, a resident in the department of obstetrics and gynecology at the Morehouse School of Medicine in Atlanta.

Dr. Gibbs and her colleagues compared the racial and ethnic makeup of sperm donors from online and self-reported profiles at 14 of the largest donor banks in the United States for March and April of 2023. Historical data were pulled from two large, national banks. The investigators compared these data to census estimates from 2021 for men between the ages of 18 and 44 years.

Donors who identified as Hispanic (10.9%) or Black (3.3%) were significantly underrepresented as compared to the U.S. population, of which Hispanic men compose 22% and Black men make up 13.3%.

Asian donors were overrepresented, making up 21.9% of the donors but only 6.5% of the U.S. population. White donors were proportionately represented in relation to national demographics, making up 56.6% of the donors and representing 55% of the U.S. population, according to the researchers. None of the donors identified as Native/Hawaiian/Pacific Islander or American Indian/Alaskan Natives; these groups represent 0.22% and 0.79% of the U.S. population, respectively.

“Next steps will be figuring out why this is happening and how to address it,” said Valerie L Baker, MD, director in the division of reproductive endocrinology and infertility at Johns Hopkins Medicine in Lutherville, Md., who was not involved in the study.

The study sheds light on the need to identify and address the barriers that discourage potential donors from underrepresented groups from participating in sperm donation, according to Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank in Scottsdale, Ariz.

“Sometimes there are inhibitors of different ethnic groups to want to act as sperm or egg donors, so trying to understand if that’s the case is important; but I’m sure a lot of it is also related to access,” Dr. Pomeroy, who was not part of the study team, said in an interview.

Longitudinal data from the two national donor banks did not indicate any significant increase or decrease in donation trends across the 5-year period from 2018 to 2022, highlighting the persisting issue of representation disparities. Dr. Gibbs said strategies need to be developed to increase recruitment of donors from underrepresented groups. Increasing the diversity of the donor pool will ultimately support family-building options for all patients, according to Dr. Gibbs.

Funding for the study was provided by the EMD Serono REI Diversity Fellowship Grant. Dr. Gibbs reports no relevant financial relationships.

Commercial sperm banks in the United States lack racially and ethnically diverse donors, potentially limiting family-planning options for patients in traditionally underserved populations, according to a study presented at the American Society for Reproductive Medicine’s 2023 meeting.

“This really highlights the need to identify barriers to increase recruitment of these donors so that we can support family-building for all populations,” said Lauren Gibbs, MD, a resident in the department of obstetrics and gynecology at the Morehouse School of Medicine in Atlanta.

Dr. Gibbs and her colleagues compared the racial and ethnic makeup of sperm donors from online and self-reported profiles at 14 of the largest donor banks in the United States for March and April of 2023. Historical data were pulled from two large, national banks. The investigators compared these data to census estimates from 2021 for men between the ages of 18 and 44 years.

Donors who identified as Hispanic (10.9%) or Black (3.3%) were significantly underrepresented as compared to the U.S. population, of which Hispanic men compose 22% and Black men make up 13.3%.

Asian donors were overrepresented, making up 21.9% of the donors but only 6.5% of the U.S. population. White donors were proportionately represented in relation to national demographics, making up 56.6% of the donors and representing 55% of the U.S. population, according to the researchers. None of the donors identified as Native/Hawaiian/Pacific Islander or American Indian/Alaskan Natives; these groups represent 0.22% and 0.79% of the U.S. population, respectively.

“Next steps will be figuring out why this is happening and how to address it,” said Valerie L Baker, MD, director in the division of reproductive endocrinology and infertility at Johns Hopkins Medicine in Lutherville, Md., who was not involved in the study.

The study sheds light on the need to identify and address the barriers that discourage potential donors from underrepresented groups from participating in sperm donation, according to Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank in Scottsdale, Ariz.

“Sometimes there are inhibitors of different ethnic groups to want to act as sperm or egg donors, so trying to understand if that’s the case is important; but I’m sure a lot of it is also related to access,” Dr. Pomeroy, who was not part of the study team, said in an interview.

Longitudinal data from the two national donor banks did not indicate any significant increase or decrease in donation trends across the 5-year period from 2018 to 2022, highlighting the persisting issue of representation disparities. Dr. Gibbs said strategies need to be developed to increase recruitment of donors from underrepresented groups. Increasing the diversity of the donor pool will ultimately support family-building options for all patients, according to Dr. Gibbs.

Funding for the study was provided by the EMD Serono REI Diversity Fellowship Grant. Dr. Gibbs reports no relevant financial relationships.

Commercial sperm banks in the United States lack racially and ethnically diverse donors, potentially limiting family-planning options for patients in traditionally underserved populations, according to a study presented at the American Society for Reproductive Medicine’s 2023 meeting.

“This really highlights the need to identify barriers to increase recruitment of these donors so that we can support family-building for all populations,” said Lauren Gibbs, MD, a resident in the department of obstetrics and gynecology at the Morehouse School of Medicine in Atlanta.

Dr. Gibbs and her colleagues compared the racial and ethnic makeup of sperm donors from online and self-reported profiles at 14 of the largest donor banks in the United States for March and April of 2023. Historical data were pulled from two large, national banks. The investigators compared these data to census estimates from 2021 for men between the ages of 18 and 44 years.

Donors who identified as Hispanic (10.9%) or Black (3.3%) were significantly underrepresented as compared to the U.S. population, of which Hispanic men compose 22% and Black men make up 13.3%.

Asian donors were overrepresented, making up 21.9% of the donors but only 6.5% of the U.S. population. White donors were proportionately represented in relation to national demographics, making up 56.6% of the donors and representing 55% of the U.S. population, according to the researchers. None of the donors identified as Native/Hawaiian/Pacific Islander or American Indian/Alaskan Natives; these groups represent 0.22% and 0.79% of the U.S. population, respectively.

“Next steps will be figuring out why this is happening and how to address it,” said Valerie L Baker, MD, director in the division of reproductive endocrinology and infertility at Johns Hopkins Medicine in Lutherville, Md., who was not involved in the study.

The study sheds light on the need to identify and address the barriers that discourage potential donors from underrepresented groups from participating in sperm donation, according to Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank in Scottsdale, Ariz.

“Sometimes there are inhibitors of different ethnic groups to want to act as sperm or egg donors, so trying to understand if that’s the case is important; but I’m sure a lot of it is also related to access,” Dr. Pomeroy, who was not part of the study team, said in an interview.

Longitudinal data from the two national donor banks did not indicate any significant increase or decrease in donation trends across the 5-year period from 2018 to 2022, highlighting the persisting issue of representation disparities. Dr. Gibbs said strategies need to be developed to increase recruitment of donors from underrepresented groups. Increasing the diversity of the donor pool will ultimately support family-building options for all patients, according to Dr. Gibbs.

Funding for the study was provided by the EMD Serono REI Diversity Fellowship Grant. Dr. Gibbs reports no relevant financial relationships.

Testosterone replacement therapy (TRT) is more effective than placebo in both correcting anemia and preventing anemia in middle-aged and older men with hypogonadism, according to a new analysis published online in JAMA Network Open.

The analysis comes from a randomized, placebo-controlled trial that included 5,204 men with hypogonadism at 316 U.S. sites. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study. That study looked at whether TRT had an effect on major cardiovascular events and results were published earlier this year in the New England Journal of Medicine.
 

Hypogonadism increases with age

Hypogonadism includes specific symptoms in addition to a low testosterone level and has a lower prevalence (about 6%-12% vs. about 25% with low testosterone alone) in men 40-70 years old in the Massachusetts Male Aging Study (MMAS). But it is still common and increases with age, note authors of the current study, led by Karol M. Pencina, PhD, with the Research Program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital and Harvard Medical School, Boston.

Symptoms of hypogonadism include lower libido, erectile dysfunction, fatigue, reduced muscle mass, poor concentration, and disturbed sleep.
 

No approved treatment

Currently, there is no approved treatment for unexplained anemia during aging and nearly 15% of older men with hypogonadism experience anemia, the authors explain.

The proportion of participants whose anemia was corrected was significantly higher in the TRT group than the placebo group at 6 months (143 of 349 [41.0%] vs. 122 of 360 [27.5%]), 12 months (45.0% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%), and 48 months (44.6% vs. 39.2%); omnibus test P = .002.

A second aim in the study was to determine the effect of TRT on the development of anemia in participants who did not have anemia at enrollment.

In that group, a significantly smaller proportion of participants in the treatment group developed anemia, compared with the placebo group at 6 months (143 of 1,997 [7.2%] vs. 203 of 1,958 [10.4%]), 12 months (7.1% vs. 9.0%), 24 months (10.0% vs. 12.3%), 36 months (10.0% vs. 12.9%), and 48 months (9.0% vs 10.2%); omnibus test P  = .02.

The men in the study had an average age of 64.8; 66.7% were White; 30.3% were Black; 2% were other.
 

Clinical implications

Shabbir M. H. Alibhai, MD, MSc, with the Institute of Health Policy, Management, and Evaluation, Institute of Medical Sciences, department of medicine, University of Toronto, writes in an invited commentary that this is one of the largest trials of TRT and was well-designed and executed. He points out that it had a long follow-up (mean duration on TRT was more than 20 months).

Given the results, he says, “TRT appears to be generally safe in middle-aged and older men with symptomatic hypogonadism, corrected mild anemia in 10%-15% of recipients, and prevented anemia in 2%-3%, with small improvements in energy but no effect on self-reported cognitive function.”

He said that without further details on long-term benefit, “I would not offer TRT primarily to treat asymptomatic normocytic anemia in men with low testosterone levels. It is reasonable to offer TRT to men with symptomatic hypogonadism regardless of hemoglobin level.”

He advises counseling patients that they could see small increases in hemoglobin levels with TRT, with a small boost in energy if they had anemia, but the effect on cognition, well-being, or function is unclear.

He further advised, “Hemoglobin levels should be monitored in men starting TRT (to detect the development of polycythemia), and prostate-specific antigen levels should be normal prior to start of treatment. Of course, a basic workup for causes of anemia, guided by history and basic parameters such as the mean corpuscular volume and blood film, should be performed in all men with anemia regardless of levels.”

The study was funded by a consortium of testosterone manufacturers led by AbbVie. Coauthors Dr. Artz, Dr. Chan, and Dr. Diegel report receiving consulting fees, grants, or employment from several pharmaceutical companies including AbbVie. Dr. Alibhai reports no relevant financial relationships.

Testosterone replacement therapy (TRT) is more effective than placebo in both correcting anemia and preventing anemia in middle-aged and older men with hypogonadism, according to a new analysis published online in JAMA Network Open.

The analysis comes from a randomized, placebo-controlled trial that included 5,204 men with hypogonadism at 316 U.S. sites. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study. That study looked at whether TRT had an effect on major cardiovascular events and results were published earlier this year in the New England Journal of Medicine.
 

Hypogonadism increases with age

Hypogonadism includes specific symptoms in addition to a low testosterone level and has a lower prevalence (about 6%-12% vs. about 25% with low testosterone alone) in men 40-70 years old in the Massachusetts Male Aging Study (MMAS). But it is still common and increases with age, note authors of the current study, led by Karol M. Pencina, PhD, with the Research Program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital and Harvard Medical School, Boston.

Symptoms of hypogonadism include lower libido, erectile dysfunction, fatigue, reduced muscle mass, poor concentration, and disturbed sleep.
 

No approved treatment

Currently, there is no approved treatment for unexplained anemia during aging and nearly 15% of older men with hypogonadism experience anemia, the authors explain.

The proportion of participants whose anemia was corrected was significantly higher in the TRT group than the placebo group at 6 months (143 of 349 [41.0%] vs. 122 of 360 [27.5%]), 12 months (45.0% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%), and 48 months (44.6% vs. 39.2%); omnibus test P = .002.

A second aim in the study was to determine the effect of TRT on the development of anemia in participants who did not have anemia at enrollment.

In that group, a significantly smaller proportion of participants in the treatment group developed anemia, compared with the placebo group at 6 months (143 of 1,997 [7.2%] vs. 203 of 1,958 [10.4%]), 12 months (7.1% vs. 9.0%), 24 months (10.0% vs. 12.3%), 36 months (10.0% vs. 12.9%), and 48 months (9.0% vs 10.2%); omnibus test P  = .02.

The men in the study had an average age of 64.8; 66.7% were White; 30.3% were Black; 2% were other.
 

Clinical implications

Shabbir M. H. Alibhai, MD, MSc, with the Institute of Health Policy, Management, and Evaluation, Institute of Medical Sciences, department of medicine, University of Toronto, writes in an invited commentary that this is one of the largest trials of TRT and was well-designed and executed. He points out that it had a long follow-up (mean duration on TRT was more than 20 months).

Given the results, he says, “TRT appears to be generally safe in middle-aged and older men with symptomatic hypogonadism, corrected mild anemia in 10%-15% of recipients, and prevented anemia in 2%-3%, with small improvements in energy but no effect on self-reported cognitive function.”

He said that without further details on long-term benefit, “I would not offer TRT primarily to treat asymptomatic normocytic anemia in men with low testosterone levels. It is reasonable to offer TRT to men with symptomatic hypogonadism regardless of hemoglobin level.”

He advises counseling patients that they could see small increases in hemoglobin levels with TRT, with a small boost in energy if they had anemia, but the effect on cognition, well-being, or function is unclear.

He further advised, “Hemoglobin levels should be monitored in men starting TRT (to detect the development of polycythemia), and prostate-specific antigen levels should be normal prior to start of treatment. Of course, a basic workup for causes of anemia, guided by history and basic parameters such as the mean corpuscular volume and blood film, should be performed in all men with anemia regardless of levels.”

The study was funded by a consortium of testosterone manufacturers led by AbbVie. Coauthors Dr. Artz, Dr. Chan, and Dr. Diegel report receiving consulting fees, grants, or employment from several pharmaceutical companies including AbbVie. Dr. Alibhai reports no relevant financial relationships.

Testosterone replacement therapy (TRT) is more effective than placebo in both correcting anemia and preventing anemia in middle-aged and older men with hypogonadism, according to a new analysis published online in JAMA Network Open.

The analysis comes from a randomized, placebo-controlled trial that included 5,204 men with hypogonadism at 316 U.S. sites. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study. That study looked at whether TRT had an effect on major cardiovascular events and results were published earlier this year in the New England Journal of Medicine.
 

Hypogonadism increases with age

Hypogonadism includes specific symptoms in addition to a low testosterone level and has a lower prevalence (about 6%-12% vs. about 25% with low testosterone alone) in men 40-70 years old in the Massachusetts Male Aging Study (MMAS). But it is still common and increases with age, note authors of the current study, led by Karol M. Pencina, PhD, with the Research Program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital and Harvard Medical School, Boston.

Symptoms of hypogonadism include lower libido, erectile dysfunction, fatigue, reduced muscle mass, poor concentration, and disturbed sleep.
 

No approved treatment

Currently, there is no approved treatment for unexplained anemia during aging and nearly 15% of older men with hypogonadism experience anemia, the authors explain.

The proportion of participants whose anemia was corrected was significantly higher in the TRT group than the placebo group at 6 months (143 of 349 [41.0%] vs. 122 of 360 [27.5%]), 12 months (45.0% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%), and 48 months (44.6% vs. 39.2%); omnibus test P = .002.

A second aim in the study was to determine the effect of TRT on the development of anemia in participants who did not have anemia at enrollment.

In that group, a significantly smaller proportion of participants in the treatment group developed anemia, compared with the placebo group at 6 months (143 of 1,997 [7.2%] vs. 203 of 1,958 [10.4%]), 12 months (7.1% vs. 9.0%), 24 months (10.0% vs. 12.3%), 36 months (10.0% vs. 12.9%), and 48 months (9.0% vs 10.2%); omnibus test P  = .02.

The men in the study had an average age of 64.8; 66.7% were White; 30.3% were Black; 2% were other.
 

Clinical implications

Shabbir M. H. Alibhai, MD, MSc, with the Institute of Health Policy, Management, and Evaluation, Institute of Medical Sciences, department of medicine, University of Toronto, writes in an invited commentary that this is one of the largest trials of TRT and was well-designed and executed. He points out that it had a long follow-up (mean duration on TRT was more than 20 months).

Given the results, he says, “TRT appears to be generally safe in middle-aged and older men with symptomatic hypogonadism, corrected mild anemia in 10%-15% of recipients, and prevented anemia in 2%-3%, with small improvements in energy but no effect on self-reported cognitive function.”

He said that without further details on long-term benefit, “I would not offer TRT primarily to treat asymptomatic normocytic anemia in men with low testosterone levels. It is reasonable to offer TRT to men with symptomatic hypogonadism regardless of hemoglobin level.”

He advises counseling patients that they could see small increases in hemoglobin levels with TRT, with a small boost in energy if they had anemia, but the effect on cognition, well-being, or function is unclear.

He further advised, “Hemoglobin levels should be monitored in men starting TRT (to detect the development of polycythemia), and prostate-specific antigen levels should be normal prior to start of treatment. Of course, a basic workup for causes of anemia, guided by history and basic parameters such as the mean corpuscular volume and blood film, should be performed in all men with anemia regardless of levels.”

The study was funded by a consortium of testosterone manufacturers led by AbbVie. Coauthors Dr. Artz, Dr. Chan, and Dr. Diegel report receiving consulting fees, grants, or employment from several pharmaceutical companies including AbbVie. Dr. Alibhai reports no relevant financial relationships.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

A version of this article first appeared on Medscape.com.

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

A version of this article first appeared on Medscape.com.

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

A version of this article first appeared on Medscape.com.

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

A disproportionate and unique number of obstacles exist in reproductive health care for patients based on race, ethnicity, geography, socioeconomic, LGBTQ+, and disability status. These barriers represent inequality in access to reproductive medical services.

These challenges are also seen in other reproductive disorders such as polycystic ovary syndrome (PCOS), fibroids, and endometriosis. It is estimated that < 25% of individuals with infertility in the United States access the resources required to have their treatment needs met (Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.113)

Fertility CARE

In 2020, the American Society for Reproductive Medicine (ASRM) created a task force on Diversity, Equity, and Inclusion (DEI) chaired by Board Member Michael A. Thomas, MD. Two years later, the ASRM elevated this task force to a committee that is now chaired by Gloria Richard-Davis, MD. As health care systems and societies increasingly recognize these obstacles to care, I invited Dr. Thomas, the current president of the ASRM, to address this vital concern. Dr. Thomas is professor and chair, department of obstetrics and gynecology, at the University of Cincinnati.
 

While not limited to reproductive health care, how prevalent is the lack of DEI and what factors contribute to this problem?

When we established the initial ASRM DEI task force, we wanted to look at DEI issues within our profession and as an access-to-care initiative. We found that ASRM and ABOG (American Board of Obstetrics and Gynecology) were not asking questions about the makeup of our REI (Reproductive Endocrinology & Infertility) providers, nursing staff, and lab personnel. We had some older data from 2018 about the REI fellowships. Since that time, there appears to be an upward trend of people of color in REI fellowships.

University of Cincinnati

We still need more data about academic, hybrid, and private REI practices when it comes to all employees. The goal would be to increase the number of people of color in all aspects of our field.

As far as access to care, we know that people of color do not have the ability to undergo ART (assisted reproductive technology) procedures at the same rate. This could be due to affordability, slower and/or later referral patterns, and personal stigma issues. Even in mandated states, people of color are seen by IVF providers in lower numbers. There is a need for a better understanding of the access-to-care issues, especially when affordability is not a problem, and the barriers to our LGBTQ+ patients.
 

Can you provide information about actions by the ASRM DEI task force and any plans for the future?

The DEI task force is now an ASRM committee. This committee is chaired by Dr. Gloria Richard-Davis and continues to work on increasing people of color in the REI workforce and understanding and decreasing access to care issues faced by people of color and members of the LGBTQ+ community.

What can physicians do at the local, state, and national level to support DEI?

All REI and ob.gyn. physicians can work with insurance companies to work on the current barriers that stand in the way of patients who want to have a family. For example, physicians can work with insurance companies to remove their definition of infertility as exposure to sperm for 1 year before fertility coverage can take effect. Also, mandated insurance coverage in all 50 states would allow even smaller companies to require this benefit to patients.

Many people of color work in smaller companies that, unfortunately, are not required to offer IVF coverage in states where mandated insurance coverage is available. As potential encouraging news, ASRM, RESOLVE (The National Infertility Association) and other patient advocacy groups are working with each state to help enact fertility mandates.
 

Which group, if any, has been most negatively affected by a lack of DEI?

People of color, LGBTQ+ communities, people with disabilities, single individuals, and those with income challenges are the most likely to be affected by adverse DEI policies.

While it is long overdue, why do you believe DEI has become such a touchstone and pervasive movement at this time?

This is the million-dollar question. After the George Floyd death, there was a global re-examination of how people of color were treated in every aspect of society. ASRM was the first to start this DEI initiative in women’s health.

ASRM and its patient advocacy partners are working with every nonmandated state toward the goal of passing infertility legislation to dramatically reduce the financial burden on all patients. We are starting to see more states either coming on board with mandates or at least discussing the possibilities. ASRM and RESOLVE have seen some recent positive outcomes with improved insurance for military families and government workers.
 

We can all agree that access to infertility treatment, particularly IVF, is not equivalent among different racial/ethnic populations. Part of the ASRM DEI task force is to evaluate research on IVF outcomes and race/ethnicity. Can you share why pregnancy outcomes would be included to potentially improve DEI?

More research needs to be done on pregnancy outcomes in women of color. We know that women of color have a decreased pregnancy rate in ART cycles even when controlling for age and other factors. We also know that birth outcomes are worse in these women. More understanding of this problem for women of color, especially African American women needs to be done.

Estimates are that more than one in eight LGBTQ+ patients live in states where physicians can refuse to treat them. Consequently, how can we improve DEI in these regions?

As someone with a number of family members in the LGBTQ+ community, this is a problem that is close to my heart. There appear to be many barriers that are being built to disenfranchise our LGBTQ+ community members. It is up to ASRM and patient advocacy groups to work with legislators to pass more inclusive laws and for insurance companies to update their definitions of infertility to be more inclusive for all.

Any final comments?

Everyone should have the right to become a parent whether they want to now or in the future!

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

A disproportionate and unique number of obstacles exist in reproductive health care for patients based on race, ethnicity, geography, socioeconomic, LGBTQ+, and disability status. These barriers represent inequality in access to reproductive medical services.

These challenges are also seen in other reproductive disorders such as polycystic ovary syndrome (PCOS), fibroids, and endometriosis. It is estimated that < 25% of individuals with infertility in the United States access the resources required to have their treatment needs met (Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.113)

Fertility CARE

In 2020, the American Society for Reproductive Medicine (ASRM) created a task force on Diversity, Equity, and Inclusion (DEI) chaired by Board Member Michael A. Thomas, MD. Two years later, the ASRM elevated this task force to a committee that is now chaired by Gloria Richard-Davis, MD. As health care systems and societies increasingly recognize these obstacles to care, I invited Dr. Thomas, the current president of the ASRM, to address this vital concern. Dr. Thomas is professor and chair, department of obstetrics and gynecology, at the University of Cincinnati.
 

While not limited to reproductive health care, how prevalent is the lack of DEI and what factors contribute to this problem?

When we established the initial ASRM DEI task force, we wanted to look at DEI issues within our profession and as an access-to-care initiative. We found that ASRM and ABOG (American Board of Obstetrics and Gynecology) were not asking questions about the makeup of our REI (Reproductive Endocrinology & Infertility) providers, nursing staff, and lab personnel. We had some older data from 2018 about the REI fellowships. Since that time, there appears to be an upward trend of people of color in REI fellowships.

University of Cincinnati

We still need more data about academic, hybrid, and private REI practices when it comes to all employees. The goal would be to increase the number of people of color in all aspects of our field.

As far as access to care, we know that people of color do not have the ability to undergo ART (assisted reproductive technology) procedures at the same rate. This could be due to affordability, slower and/or later referral patterns, and personal stigma issues. Even in mandated states, people of color are seen by IVF providers in lower numbers. There is a need for a better understanding of the access-to-care issues, especially when affordability is not a problem, and the barriers to our LGBTQ+ patients.
 

Can you provide information about actions by the ASRM DEI task force and any plans for the future?

The DEI task force is now an ASRM committee. This committee is chaired by Dr. Gloria Richard-Davis and continues to work on increasing people of color in the REI workforce and understanding and decreasing access to care issues faced by people of color and members of the LGBTQ+ community.

What can physicians do at the local, state, and national level to support DEI?

All REI and ob.gyn. physicians can work with insurance companies to work on the current barriers that stand in the way of patients who want to have a family. For example, physicians can work with insurance companies to remove their definition of infertility as exposure to sperm for 1 year before fertility coverage can take effect. Also, mandated insurance coverage in all 50 states would allow even smaller companies to require this benefit to patients.

Many people of color work in smaller companies that, unfortunately, are not required to offer IVF coverage in states where mandated insurance coverage is available. As potential encouraging news, ASRM, RESOLVE (The National Infertility Association) and other patient advocacy groups are working with each state to help enact fertility mandates.
 

Which group, if any, has been most negatively affected by a lack of DEI?

People of color, LGBTQ+ communities, people with disabilities, single individuals, and those with income challenges are the most likely to be affected by adverse DEI policies.

While it is long overdue, why do you believe DEI has become such a touchstone and pervasive movement at this time?

This is the million-dollar question. After the George Floyd death, there was a global re-examination of how people of color were treated in every aspect of society. ASRM was the first to start this DEI initiative in women’s health.

ASRM and its patient advocacy partners are working with every nonmandated state toward the goal of passing infertility legislation to dramatically reduce the financial burden on all patients. We are starting to see more states either coming on board with mandates or at least discussing the possibilities. ASRM and RESOLVE have seen some recent positive outcomes with improved insurance for military families and government workers.
 

We can all agree that access to infertility treatment, particularly IVF, is not equivalent among different racial/ethnic populations. Part of the ASRM DEI task force is to evaluate research on IVF outcomes and race/ethnicity. Can you share why pregnancy outcomes would be included to potentially improve DEI?

More research needs to be done on pregnancy outcomes in women of color. We know that women of color have a decreased pregnancy rate in ART cycles even when controlling for age and other factors. We also know that birth outcomes are worse in these women. More understanding of this problem for women of color, especially African American women needs to be done.

Estimates are that more than one in eight LGBTQ+ patients live in states where physicians can refuse to treat them. Consequently, how can we improve DEI in these regions?

As someone with a number of family members in the LGBTQ+ community, this is a problem that is close to my heart. There appear to be many barriers that are being built to disenfranchise our LGBTQ+ community members. It is up to ASRM and patient advocacy groups to work with legislators to pass more inclusive laws and for insurance companies to update their definitions of infertility to be more inclusive for all.

Any final comments?

Everyone should have the right to become a parent whether they want to now or in the future!

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

A disproportionate and unique number of obstacles exist in reproductive health care for patients based on race, ethnicity, geography, socioeconomic, LGBTQ+, and disability status. These barriers represent inequality in access to reproductive medical services.

These challenges are also seen in other reproductive disorders such as polycystic ovary syndrome (PCOS), fibroids, and endometriosis. It is estimated that < 25% of individuals with infertility in the United States access the resources required to have their treatment needs met (Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.113)

Fertility CARE

In 2020, the American Society for Reproductive Medicine (ASRM) created a task force on Diversity, Equity, and Inclusion (DEI) chaired by Board Member Michael A. Thomas, MD. Two years later, the ASRM elevated this task force to a committee that is now chaired by Gloria Richard-Davis, MD. As health care systems and societies increasingly recognize these obstacles to care, I invited Dr. Thomas, the current president of the ASRM, to address this vital concern. Dr. Thomas is professor and chair, department of obstetrics and gynecology, at the University of Cincinnati.
 

While not limited to reproductive health care, how prevalent is the lack of DEI and what factors contribute to this problem?

When we established the initial ASRM DEI task force, we wanted to look at DEI issues within our profession and as an access-to-care initiative. We found that ASRM and ABOG (American Board of Obstetrics and Gynecology) were not asking questions about the makeup of our REI (Reproductive Endocrinology & Infertility) providers, nursing staff, and lab personnel. We had some older data from 2018 about the REI fellowships. Since that time, there appears to be an upward trend of people of color in REI fellowships.

University of Cincinnati

We still need more data about academic, hybrid, and private REI practices when it comes to all employees. The goal would be to increase the number of people of color in all aspects of our field.

As far as access to care, we know that people of color do not have the ability to undergo ART (assisted reproductive technology) procedures at the same rate. This could be due to affordability, slower and/or later referral patterns, and personal stigma issues. Even in mandated states, people of color are seen by IVF providers in lower numbers. There is a need for a better understanding of the access-to-care issues, especially when affordability is not a problem, and the barriers to our LGBTQ+ patients.
 

Can you provide information about actions by the ASRM DEI task force and any plans for the future?

The DEI task force is now an ASRM committee. This committee is chaired by Dr. Gloria Richard-Davis and continues to work on increasing people of color in the REI workforce and understanding and decreasing access to care issues faced by people of color and members of the LGBTQ+ community.

What can physicians do at the local, state, and national level to support DEI?

All REI and ob.gyn. physicians can work with insurance companies to work on the current barriers that stand in the way of patients who want to have a family. For example, physicians can work with insurance companies to remove their definition of infertility as exposure to sperm for 1 year before fertility coverage can take effect. Also, mandated insurance coverage in all 50 states would allow even smaller companies to require this benefit to patients.

Many people of color work in smaller companies that, unfortunately, are not required to offer IVF coverage in states where mandated insurance coverage is available. As potential encouraging news, ASRM, RESOLVE (The National Infertility Association) and other patient advocacy groups are working with each state to help enact fertility mandates.
 

Which group, if any, has been most negatively affected by a lack of DEI?

People of color, LGBTQ+ communities, people with disabilities, single individuals, and those with income challenges are the most likely to be affected by adverse DEI policies.

While it is long overdue, why do you believe DEI has become such a touchstone and pervasive movement at this time?

This is the million-dollar question. After the George Floyd death, there was a global re-examination of how people of color were treated in every aspect of society. ASRM was the first to start this DEI initiative in women’s health.

ASRM and its patient advocacy partners are working with every nonmandated state toward the goal of passing infertility legislation to dramatically reduce the financial burden on all patients. We are starting to see more states either coming on board with mandates or at least discussing the possibilities. ASRM and RESOLVE have seen some recent positive outcomes with improved insurance for military families and government workers.
 

We can all agree that access to infertility treatment, particularly IVF, is not equivalent among different racial/ethnic populations. Part of the ASRM DEI task force is to evaluate research on IVF outcomes and race/ethnicity. Can you share why pregnancy outcomes would be included to potentially improve DEI?

More research needs to be done on pregnancy outcomes in women of color. We know that women of color have a decreased pregnancy rate in ART cycles even when controlling for age and other factors. We also know that birth outcomes are worse in these women. More understanding of this problem for women of color, especially African American women needs to be done.

Estimates are that more than one in eight LGBTQ+ patients live in states where physicians can refuse to treat them. Consequently, how can we improve DEI in these regions?

As someone with a number of family members in the LGBTQ+ community, this is a problem that is close to my heart. There appear to be many barriers that are being built to disenfranchise our LGBTQ+ community members. It is up to ASRM and patient advocacy groups to work with legislators to pass more inclusive laws and for insurance companies to update their definitions of infertility to be more inclusive for all.

Any final comments?

Everyone should have the right to become a parent whether they want to now or in the future!

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Women with premenstrual disorders may be more likely go through menopause before they are 45 years old, a new study suggests. 

Women with premenstrual disorders, or PMDs, were also more likely to have moderate or severe night sweats or hot flashes during menopause, the researchers found.

Published in JAMA Network Open, the new findings stem from data from more than 3,600 nurses who contributed their health information to a database between 1991 and 2017. Women with PMDs were more than twice as likely as women without PMDs to have early menopause.

Most women have menopause between the ages of 45 and 55 years old, according to the World Health Organization. 

There are numerous PMDs, including the well-known premenstrual syndrome, which is considered a mild disorder affecting up to 30% of women that causes symptoms like crankiness and bloating. A less common PMD is premenstrual dysphoric disorder, which can severely impact a woman’s life through psychological, gastrointestinal, skin, and neurological problems.

Previous research has linked PMDs during the reproductive years and postmenopausal issues like hot flashes and night sweats to increased risks of health problems like high blood pressure, heart conditions, and diabetes.

“It is important to identify women at risk for early menopause because of its link with poorer heart, brain, and bone health,” Stephanie Faubion, MD, MBA, a doctor at the Mayo Clinic and medical director of the North American Menopause Society, told CNN. Dr. Faubion was not involved in the study.

That said, it’s important to note that the study was observational – meaning researchers can’t say for certain that PMDs will cause early menopause. Rather, the study shows there may be a correlation between the two, Donghao Lu, MD, an associate professor in the department of medical epidemiology and biostatistics at the Karolinska Institute, told CNN.

A version of this article first appeared on Medscape.com.

Women with premenstrual disorders may be more likely go through menopause before they are 45 years old, a new study suggests. 

Women with premenstrual disorders, or PMDs, were also more likely to have moderate or severe night sweats or hot flashes during menopause, the researchers found.

Published in JAMA Network Open, the new findings stem from data from more than 3,600 nurses who contributed their health information to a database between 1991 and 2017. Women with PMDs were more than twice as likely as women without PMDs to have early menopause.

Most women have menopause between the ages of 45 and 55 years old, according to the World Health Organization. 

There are numerous PMDs, including the well-known premenstrual syndrome, which is considered a mild disorder affecting up to 30% of women that causes symptoms like crankiness and bloating. A less common PMD is premenstrual dysphoric disorder, which can severely impact a woman’s life through psychological, gastrointestinal, skin, and neurological problems.

Previous research has linked PMDs during the reproductive years and postmenopausal issues like hot flashes and night sweats to increased risks of health problems like high blood pressure, heart conditions, and diabetes.

“It is important to identify women at risk for early menopause because of its link with poorer heart, brain, and bone health,” Stephanie Faubion, MD, MBA, a doctor at the Mayo Clinic and medical director of the North American Menopause Society, told CNN. Dr. Faubion was not involved in the study.

That said, it’s important to note that the study was observational – meaning researchers can’t say for certain that PMDs will cause early menopause. Rather, the study shows there may be a correlation between the two, Donghao Lu, MD, an associate professor in the department of medical epidemiology and biostatistics at the Karolinska Institute, told CNN.

A version of this article first appeared on Medscape.com.

Women with premenstrual disorders may be more likely go through menopause before they are 45 years old, a new study suggests. 

Women with premenstrual disorders, or PMDs, were also more likely to have moderate or severe night sweats or hot flashes during menopause, the researchers found.

Published in JAMA Network Open, the new findings stem from data from more than 3,600 nurses who contributed their health information to a database between 1991 and 2017. Women with PMDs were more than twice as likely as women without PMDs to have early menopause.

Most women have menopause between the ages of 45 and 55 years old, according to the World Health Organization. 

There are numerous PMDs, including the well-known premenstrual syndrome, which is considered a mild disorder affecting up to 30% of women that causes symptoms like crankiness and bloating. A less common PMD is premenstrual dysphoric disorder, which can severely impact a woman’s life through psychological, gastrointestinal, skin, and neurological problems.

Previous research has linked PMDs during the reproductive years and postmenopausal issues like hot flashes and night sweats to increased risks of health problems like high blood pressure, heart conditions, and diabetes.

“It is important to identify women at risk for early menopause because of its link with poorer heart, brain, and bone health,” Stephanie Faubion, MD, MBA, a doctor at the Mayo Clinic and medical director of the North American Menopause Society, told CNN. Dr. Faubion was not involved in the study.

That said, it’s important to note that the study was observational – meaning researchers can’t say for certain that PMDs will cause early menopause. Rather, the study shows there may be a correlation between the two, Donghao Lu, MD, an associate professor in the department of medical epidemiology and biostatistics at the Karolinska Institute, told CNN.

A version of this article first appeared on Medscape.com.