Study: HIV Screening in Pregnancy Falls Short

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Study: HIV Screening in Pregnancy Falls Short

MONTREAL — HIV screening of pregnant women falls well short of national guidelines, particularly among patients seen in private practice, according to a study presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“We have to really reinforce with all providers the importance of universal screening,” said Dr. Harold Wiesenfeld, senior investigator of the study, which found that patients were 17.5 times less likely to undergo screening in private practice than were those in a clinic setting.

The study of 300 women revealed that 61% had no HIV screening results in their medical record at the time of parturition.

Guidelines adopted in 1999 by the Institute of Medicine, the Centers for Disease Control, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics recommend routine, universal HIV screening in pregnancy to avoid vertical transmission, said study presenter Margaret Kennedy.

Ms. Kennedy is a student at the University of Pittsburgh School of Medicine.

But among the study's subjects, all of whom were questioned up to 72 hours before delivery, only 65% reported undergoing HIV screening during pregnancy, while 25% reported no screening, and 10% were not sure if they had been tested.

Multivariate analysis of the data revealed that being white and married were each independently associated with a threefold greater risk of not being screened.

The provider's influence was the most important factor in screening, said Ms. Kennedy.

Women whose provider did not consider screening important were14 times more likely to be unscreened; those whose providers considered screening optional were 2.9 times more likely to be unscreened.

On the other hand, women whose providers encouraged screening were 3.7 times more likely to have undergone screening.

“My personal opinion is the importance of HIV screening is not stressed in many patient/provider encounters,” said Dr. Wiesenfeld.

“Some providers don't think HIV is relevant to their population because they have an affluent population. It mirrors chlamydia screening. They don't think their patients are at risk,” the physician related.

A comparison of medical records with subjects' responses revealed some recall bias.

Two percent of those who reported having been tested had actually declined testing.

Of those who reporting no screening, 11% had actually been screened (35% said they had not been offered screening, and 65% said they had declined).

In addition, 17% of those who were unsure had been screened.

“Universal offering of HIV screening as an opt-out, in conjunction with encouragement from providers, may greatly increase prenatal HIV screening rates,” Ms. Kennedy said.

“Universal HIV screening is not at the rates we would like across the country,” concluded Dr. Wiesenfeld.

“The take-home message is that it's low—but what's more important is who is not being screened. Women who are white, and affluent, and in a private practice center … are less likely to be screened, as are those who don't feel their provider is encouraging it,” he opined.

The investigators said they had no conflicts of interest.

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MONTREAL — HIV screening of pregnant women falls well short of national guidelines, particularly among patients seen in private practice, according to a study presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“We have to really reinforce with all providers the importance of universal screening,” said Dr. Harold Wiesenfeld, senior investigator of the study, which found that patients were 17.5 times less likely to undergo screening in private practice than were those in a clinic setting.

The study of 300 women revealed that 61% had no HIV screening results in their medical record at the time of parturition.

Guidelines adopted in 1999 by the Institute of Medicine, the Centers for Disease Control, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics recommend routine, universal HIV screening in pregnancy to avoid vertical transmission, said study presenter Margaret Kennedy.

Ms. Kennedy is a student at the University of Pittsburgh School of Medicine.

But among the study's subjects, all of whom were questioned up to 72 hours before delivery, only 65% reported undergoing HIV screening during pregnancy, while 25% reported no screening, and 10% were not sure if they had been tested.

Multivariate analysis of the data revealed that being white and married were each independently associated with a threefold greater risk of not being screened.

The provider's influence was the most important factor in screening, said Ms. Kennedy.

Women whose provider did not consider screening important were14 times more likely to be unscreened; those whose providers considered screening optional were 2.9 times more likely to be unscreened.

On the other hand, women whose providers encouraged screening were 3.7 times more likely to have undergone screening.

“My personal opinion is the importance of HIV screening is not stressed in many patient/provider encounters,” said Dr. Wiesenfeld.

“Some providers don't think HIV is relevant to their population because they have an affluent population. It mirrors chlamydia screening. They don't think their patients are at risk,” the physician related.

A comparison of medical records with subjects' responses revealed some recall bias.

Two percent of those who reported having been tested had actually declined testing.

Of those who reporting no screening, 11% had actually been screened (35% said they had not been offered screening, and 65% said they had declined).

In addition, 17% of those who were unsure had been screened.

“Universal offering of HIV screening as an opt-out, in conjunction with encouragement from providers, may greatly increase prenatal HIV screening rates,” Ms. Kennedy said.

“Universal HIV screening is not at the rates we would like across the country,” concluded Dr. Wiesenfeld.

“The take-home message is that it's low—but what's more important is who is not being screened. Women who are white, and affluent, and in a private practice center … are less likely to be screened, as are those who don't feel their provider is encouraging it,” he opined.

The investigators said they had no conflicts of interest.

MONTREAL — HIV screening of pregnant women falls well short of national guidelines, particularly among patients seen in private practice, according to a study presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“We have to really reinforce with all providers the importance of universal screening,” said Dr. Harold Wiesenfeld, senior investigator of the study, which found that patients were 17.5 times less likely to undergo screening in private practice than were those in a clinic setting.

The study of 300 women revealed that 61% had no HIV screening results in their medical record at the time of parturition.

Guidelines adopted in 1999 by the Institute of Medicine, the Centers for Disease Control, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics recommend routine, universal HIV screening in pregnancy to avoid vertical transmission, said study presenter Margaret Kennedy.

Ms. Kennedy is a student at the University of Pittsburgh School of Medicine.

But among the study's subjects, all of whom were questioned up to 72 hours before delivery, only 65% reported undergoing HIV screening during pregnancy, while 25% reported no screening, and 10% were not sure if they had been tested.

Multivariate analysis of the data revealed that being white and married were each independently associated with a threefold greater risk of not being screened.

The provider's influence was the most important factor in screening, said Ms. Kennedy.

Women whose provider did not consider screening important were14 times more likely to be unscreened; those whose providers considered screening optional were 2.9 times more likely to be unscreened.

On the other hand, women whose providers encouraged screening were 3.7 times more likely to have undergone screening.

“My personal opinion is the importance of HIV screening is not stressed in many patient/provider encounters,” said Dr. Wiesenfeld.

“Some providers don't think HIV is relevant to their population because they have an affluent population. It mirrors chlamydia screening. They don't think their patients are at risk,” the physician related.

A comparison of medical records with subjects' responses revealed some recall bias.

Two percent of those who reported having been tested had actually declined testing.

Of those who reporting no screening, 11% had actually been screened (35% said they had not been offered screening, and 65% said they had declined).

In addition, 17% of those who were unsure had been screened.

“Universal offering of HIV screening as an opt-out, in conjunction with encouragement from providers, may greatly increase prenatal HIV screening rates,” Ms. Kennedy said.

“Universal HIV screening is not at the rates we would like across the country,” concluded Dr. Wiesenfeld.

“The take-home message is that it's low—but what's more important is who is not being screened. Women who are white, and affluent, and in a private practice center … are less likely to be screened, as are those who don't feel their provider is encouraging it,” he opined.

The investigators said they had no conflicts of interest.

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Expedited Partner Treatment Said to Merit Wider Application

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MONTREAL — Expedited partner treatment, also known as patient-delivered partner therapy, could substantially reduce costs and morbidity from sexually transmitted diseases if it were allowed in all states, according to Dr. Margaret Villers.

The practice allows physicians who are treating patients with sexually transmitted diseases to either provide treatment or write a prescription for their patients' partners without requiring the partners to come in to the office.

Although the Centers for Disease Control and Prevention has encouraged expedited partner treatment (EPT) since 2006, it is explicitly legal in only 19 states, and “in multiple states and localities, there are legal barriers which may prevent universal implementation,” Dr. Villers said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (For a map showing the legal status of EPT in each state, visit www.cdc.gov/std/ept/legal/default.htm

“The South Carolina statute very much mirrors the other states where it's prohibited in the sense that if you do not see a patient—if you've never met them, if you have not examined them, and if you do not have an ongoing relationship with them—then you are not allowed to prescribe a medication for them,” explained Dr. Villers of the Medical University of South Carolina, Charleston.

In a cost-utility model examining the potential impact of EPT in 11 states where it was illegal in 2007 (one state, North Dakota, has since made the practice legal), she estimated there would be a cost savings of almost $6 million and the prevention of more than 2,000 cases of Chlamydia trachomatis and Neisseria gonorrhoeae annually.

The model suggested that EPT would have resulted in 984 fewer cases of chlamydia (out of the actual 196,819 cases) and 1,280 fewer cases of gonorrhea (out of the actual 56,585 cases). This would have resulted in a net savings of $1,671,387 for chlamydia and $4,163,534 for gonorrhea, and a combined gain of 453 quality-adjusted life years, she said.

In the 19 U.S. states where EPT is explicitly legal, “there are state statutes that either allow for the provision of a prescription in general or specifically for the treatment of STDs only,” she said. But the laws are “somewhat murky” in 21 states.

She said that approximately 1 year ago the American Bar Association sent an open letter to all members encouraging states and localities to pass statutes that might decrease barriers to EPT.

“Improved clarification of the legal status of EPT, whether it is a state law which only allows the prescription of medications for STDs or whether it is a broader general law, might actually make this type of treatment more acceptable to physicians,” she said in an interview.

Dr. Villers noted that her study probably underestimates the benefits of EPT by assuming that the infected patient is female, and by considering only the 3-month period following her treatment. In addition, “we did not take into account multiple sexual partners, and we also only looked at direct medical costs.”

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MONTREAL — Expedited partner treatment, also known as patient-delivered partner therapy, could substantially reduce costs and morbidity from sexually transmitted diseases if it were allowed in all states, according to Dr. Margaret Villers.

The practice allows physicians who are treating patients with sexually transmitted diseases to either provide treatment or write a prescription for their patients' partners without requiring the partners to come in to the office.

Although the Centers for Disease Control and Prevention has encouraged expedited partner treatment (EPT) since 2006, it is explicitly legal in only 19 states, and “in multiple states and localities, there are legal barriers which may prevent universal implementation,” Dr. Villers said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (For a map showing the legal status of EPT in each state, visit www.cdc.gov/std/ept/legal/default.htm

“The South Carolina statute very much mirrors the other states where it's prohibited in the sense that if you do not see a patient—if you've never met them, if you have not examined them, and if you do not have an ongoing relationship with them—then you are not allowed to prescribe a medication for them,” explained Dr. Villers of the Medical University of South Carolina, Charleston.

In a cost-utility model examining the potential impact of EPT in 11 states where it was illegal in 2007 (one state, North Dakota, has since made the practice legal), she estimated there would be a cost savings of almost $6 million and the prevention of more than 2,000 cases of Chlamydia trachomatis and Neisseria gonorrhoeae annually.

The model suggested that EPT would have resulted in 984 fewer cases of chlamydia (out of the actual 196,819 cases) and 1,280 fewer cases of gonorrhea (out of the actual 56,585 cases). This would have resulted in a net savings of $1,671,387 for chlamydia and $4,163,534 for gonorrhea, and a combined gain of 453 quality-adjusted life years, she said.

In the 19 U.S. states where EPT is explicitly legal, “there are state statutes that either allow for the provision of a prescription in general or specifically for the treatment of STDs only,” she said. But the laws are “somewhat murky” in 21 states.

She said that approximately 1 year ago the American Bar Association sent an open letter to all members encouraging states and localities to pass statutes that might decrease barriers to EPT.

“Improved clarification of the legal status of EPT, whether it is a state law which only allows the prescription of medications for STDs or whether it is a broader general law, might actually make this type of treatment more acceptable to physicians,” she said in an interview.

Dr. Villers noted that her study probably underestimates the benefits of EPT by assuming that the infected patient is female, and by considering only the 3-month period following her treatment. In addition, “we did not take into account multiple sexual partners, and we also only looked at direct medical costs.”

MONTREAL — Expedited partner treatment, also known as patient-delivered partner therapy, could substantially reduce costs and morbidity from sexually transmitted diseases if it were allowed in all states, according to Dr. Margaret Villers.

The practice allows physicians who are treating patients with sexually transmitted diseases to either provide treatment or write a prescription for their patients' partners without requiring the partners to come in to the office.

Although the Centers for Disease Control and Prevention has encouraged expedited partner treatment (EPT) since 2006, it is explicitly legal in only 19 states, and “in multiple states and localities, there are legal barriers which may prevent universal implementation,” Dr. Villers said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (For a map showing the legal status of EPT in each state, visit www.cdc.gov/std/ept/legal/default.htm

“The South Carolina statute very much mirrors the other states where it's prohibited in the sense that if you do not see a patient—if you've never met them, if you have not examined them, and if you do not have an ongoing relationship with them—then you are not allowed to prescribe a medication for them,” explained Dr. Villers of the Medical University of South Carolina, Charleston.

In a cost-utility model examining the potential impact of EPT in 11 states where it was illegal in 2007 (one state, North Dakota, has since made the practice legal), she estimated there would be a cost savings of almost $6 million and the prevention of more than 2,000 cases of Chlamydia trachomatis and Neisseria gonorrhoeae annually.

The model suggested that EPT would have resulted in 984 fewer cases of chlamydia (out of the actual 196,819 cases) and 1,280 fewer cases of gonorrhea (out of the actual 56,585 cases). This would have resulted in a net savings of $1,671,387 for chlamydia and $4,163,534 for gonorrhea, and a combined gain of 453 quality-adjusted life years, she said.

In the 19 U.S. states where EPT is explicitly legal, “there are state statutes that either allow for the provision of a prescription in general or specifically for the treatment of STDs only,” she said. But the laws are “somewhat murky” in 21 states.

She said that approximately 1 year ago the American Bar Association sent an open letter to all members encouraging states and localities to pass statutes that might decrease barriers to EPT.

“Improved clarification of the legal status of EPT, whether it is a state law which only allows the prescription of medications for STDs or whether it is a broader general law, might actually make this type of treatment more acceptable to physicians,” she said in an interview.

Dr. Villers noted that her study probably underestimates the benefits of EPT by assuming that the infected patient is female, and by considering only the 3-month period following her treatment. In addition, “we did not take into account multiple sexual partners, and we also only looked at direct medical costs.”

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Neonatal MRSA Is Often Community Acquired

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MONTREAL — Community-acquired strains are the most common source of methicillin-resistant Staphylococcus aureus colonization and infection in babies in the neonatal intensive care unit, even though they have never left the hospital, researchers found.

Findings in a 5-year retrospective study of 50 MRSA-colonized neonates in the NICU were presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

"There are higher rates of community-acquired MRSA infection in our neonates than in our general adult and pediatric patient population," said lead investigator Dr. Gweneth Lazenby of the Medical University of South Carolina in Charleston said. "This is a call for people to help us really detail the sources of such early colonization, how we can prevent it, and how we can prevent subsequent infection."

Theories on how neonates are exposed to MRSA in the NICU include maternal transmission, transmission from other family or hospital workers, contaminated equipment, and a recently reported possible transmission through breast milk, she said. "We have some concern about family members and maternal transmission to neonates and so we would like to consider interrupting transmission by possibly culturing the individuals the babies are exposed to."

In the current study, there was a mean of 21 days between birth and colonization of the 50 infants. However, 30% tested positive within 7 days of birth, she said.

"The 30% of infants who acquired early MRSA colonization, within the first week, were 2.5 times more likely to go on to develop infection," she explained. No other risk factors for infection could be identified, although there was a nonsignificant trend toward a higher risk with lower birth weight.

In total, 16 of the 50 colonized infants (32%) eventually developed MRSA infections, which included 8 blood stream infections, 6 skin and soft tissue infections, and 2 ventilator-associated pneumonias. One of the bloodstream infections was fatal and was identified as a community-acquired MRSA strain (USA 300).

Pulse field gel electrophoresis identified USA 300 in 36% of 14 colonizing strains and 56% of 9 infection strains, she said. "This is considerably higher than what is seen in the rest of our hospital's pediatric and adult patient population, where we see a 4%-6% colonization rate and a 19% infection rate, with one-quarter of those infections being community-acquired."

Dr. Lazenby said decolonization is not currently attempted in neonates.

The current management is isolation and contact precautions to prevent spreading the infection, she said.

Dr. Lazenby said she had no disclosures to declare.

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MONTREAL — Community-acquired strains are the most common source of methicillin-resistant Staphylococcus aureus colonization and infection in babies in the neonatal intensive care unit, even though they have never left the hospital, researchers found.

Findings in a 5-year retrospective study of 50 MRSA-colonized neonates in the NICU were presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

"There are higher rates of community-acquired MRSA infection in our neonates than in our general adult and pediatric patient population," said lead investigator Dr. Gweneth Lazenby of the Medical University of South Carolina in Charleston said. "This is a call for people to help us really detail the sources of such early colonization, how we can prevent it, and how we can prevent subsequent infection."

Theories on how neonates are exposed to MRSA in the NICU include maternal transmission, transmission from other family or hospital workers, contaminated equipment, and a recently reported possible transmission through breast milk, she said. "We have some concern about family members and maternal transmission to neonates and so we would like to consider interrupting transmission by possibly culturing the individuals the babies are exposed to."

In the current study, there was a mean of 21 days between birth and colonization of the 50 infants. However, 30% tested positive within 7 days of birth, she said.

"The 30% of infants who acquired early MRSA colonization, within the first week, were 2.5 times more likely to go on to develop infection," she explained. No other risk factors for infection could be identified, although there was a nonsignificant trend toward a higher risk with lower birth weight.

In total, 16 of the 50 colonized infants (32%) eventually developed MRSA infections, which included 8 blood stream infections, 6 skin and soft tissue infections, and 2 ventilator-associated pneumonias. One of the bloodstream infections was fatal and was identified as a community-acquired MRSA strain (USA 300).

Pulse field gel electrophoresis identified USA 300 in 36% of 14 colonizing strains and 56% of 9 infection strains, she said. "This is considerably higher than what is seen in the rest of our hospital's pediatric and adult patient population, where we see a 4%-6% colonization rate and a 19% infection rate, with one-quarter of those infections being community-acquired."

Dr. Lazenby said decolonization is not currently attempted in neonates.

The current management is isolation and contact precautions to prevent spreading the infection, she said.

Dr. Lazenby said she had no disclosures to declare.

MONTREAL — Community-acquired strains are the most common source of methicillin-resistant Staphylococcus aureus colonization and infection in babies in the neonatal intensive care unit, even though they have never left the hospital, researchers found.

Findings in a 5-year retrospective study of 50 MRSA-colonized neonates in the NICU were presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

"There are higher rates of community-acquired MRSA infection in our neonates than in our general adult and pediatric patient population," said lead investigator Dr. Gweneth Lazenby of the Medical University of South Carolina in Charleston said. "This is a call for people to help us really detail the sources of such early colonization, how we can prevent it, and how we can prevent subsequent infection."

Theories on how neonates are exposed to MRSA in the NICU include maternal transmission, transmission from other family or hospital workers, contaminated equipment, and a recently reported possible transmission through breast milk, she said. "We have some concern about family members and maternal transmission to neonates and so we would like to consider interrupting transmission by possibly culturing the individuals the babies are exposed to."

In the current study, there was a mean of 21 days between birth and colonization of the 50 infants. However, 30% tested positive within 7 days of birth, she said.

"The 30% of infants who acquired early MRSA colonization, within the first week, were 2.5 times more likely to go on to develop infection," she explained. No other risk factors for infection could be identified, although there was a nonsignificant trend toward a higher risk with lower birth weight.

In total, 16 of the 50 colonized infants (32%) eventually developed MRSA infections, which included 8 blood stream infections, 6 skin and soft tissue infections, and 2 ventilator-associated pneumonias. One of the bloodstream infections was fatal and was identified as a community-acquired MRSA strain (USA 300).

Pulse field gel electrophoresis identified USA 300 in 36% of 14 colonizing strains and 56% of 9 infection strains, she said. "This is considerably higher than what is seen in the rest of our hospital's pediatric and adult patient population, where we see a 4%-6% colonization rate and a 19% infection rate, with one-quarter of those infections being community-acquired."

Dr. Lazenby said decolonization is not currently attempted in neonates.

The current management is isolation and contact precautions to prevent spreading the infection, she said.

Dr. Lazenby said she had no disclosures to declare.

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Consider M. genitalium in Cervical Inflammation

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MONTREAL — Mycoplasma genitalium is probably an underrecognized cause of some cases of cervicitis, but the role of the physician in screening for and treating this organism remains unclear, according to Dr. Harold Wiesenfeld of Magee-Womens Hospital and the University of Pittsburgh.

Dr. Wiesenfeld outlined his work showing a link between M. genitalium and subclinical pelvic inflammatory disease, as well as more recent findings that implicate the organism in cervicitis, at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“Many cases, perhaps most cases, of cervicitis occur in women who are negative for the traditional pathogens known to cause cervicitis, such as Neisseria gonorrhoeae and Chlamydia trachomatis,” he said in an interview. “Our findings may explain the etiology of cervicitis in some women.”

His study of 524 women at risk for lower genital tract infection and undergoing testing for sexually transmitted disease found elevated polymorphonuclear leukocytes (PMNs), a microscopic marker for cervical inflammation, in 22% of the women.

M. genitalium was identified in 8% of the overall cohort, but occurred more frequently among those with elevated PMNs compared with those without (37% vs. 21%). In fact, among all women with elevated PMNs, M. genitalium was the most common pathogen “eclipsing the more traditionally recognized cervicitis organisms,” he said.

In contrast, only 32% of those with elevated PMNs had C. trachomatis, 22% had N. gonorrhoeae, 22% had bacterial vaginosis, and 21% had Trichomonas vaginalis.

After logistic regression, infection with M. genitalium was independently associated with elevated PMNs, with an odds ratio of 2.5, he said.

“As there is an independent association between M. genitalium and cervical inflammation, it is likely that M. genitalium is the cause of a true cervical infection rather than just a colonizing organism,” he said. “I would not expect a colonizing organism to cause a cervical inflammatory response.”

To rule out confounding STDs, the analysis was then restricted to 345 women who had tested negative for gonorrhea, chlamydia, and Trichomonas species. Eight percent of this cohort tested positive for M. genitalium, and 46% of this group had elevated PMNs compared with the 18 women who had no STD infections.

“After controlling for age, M. genitalium infection was independently associated with elevated PMNs with an odds ratio of 4.7,” he said.

Only a minority of women had clinical signs of cervicitis, and there were no clinical differences between those who tested positive or negative for M. genitalium, Dr. Wiesenfeld said.

The findings shed new light on the contributions of M. genitalium to cervicitis, but “at this point I do not think that these findings will change the routine management of cervicitis,” he said.

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MONTREAL — Mycoplasma genitalium is probably an underrecognized cause of some cases of cervicitis, but the role of the physician in screening for and treating this organism remains unclear, according to Dr. Harold Wiesenfeld of Magee-Womens Hospital and the University of Pittsburgh.

Dr. Wiesenfeld outlined his work showing a link between M. genitalium and subclinical pelvic inflammatory disease, as well as more recent findings that implicate the organism in cervicitis, at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“Many cases, perhaps most cases, of cervicitis occur in women who are negative for the traditional pathogens known to cause cervicitis, such as Neisseria gonorrhoeae and Chlamydia trachomatis,” he said in an interview. “Our findings may explain the etiology of cervicitis in some women.”

His study of 524 women at risk for lower genital tract infection and undergoing testing for sexually transmitted disease found elevated polymorphonuclear leukocytes (PMNs), a microscopic marker for cervical inflammation, in 22% of the women.

M. genitalium was identified in 8% of the overall cohort, but occurred more frequently among those with elevated PMNs compared with those without (37% vs. 21%). In fact, among all women with elevated PMNs, M. genitalium was the most common pathogen “eclipsing the more traditionally recognized cervicitis organisms,” he said.

In contrast, only 32% of those with elevated PMNs had C. trachomatis, 22% had N. gonorrhoeae, 22% had bacterial vaginosis, and 21% had Trichomonas vaginalis.

After logistic regression, infection with M. genitalium was independently associated with elevated PMNs, with an odds ratio of 2.5, he said.

“As there is an independent association between M. genitalium and cervical inflammation, it is likely that M. genitalium is the cause of a true cervical infection rather than just a colonizing organism,” he said. “I would not expect a colonizing organism to cause a cervical inflammatory response.”

To rule out confounding STDs, the analysis was then restricted to 345 women who had tested negative for gonorrhea, chlamydia, and Trichomonas species. Eight percent of this cohort tested positive for M. genitalium, and 46% of this group had elevated PMNs compared with the 18 women who had no STD infections.

“After controlling for age, M. genitalium infection was independently associated with elevated PMNs with an odds ratio of 4.7,” he said.

Only a minority of women had clinical signs of cervicitis, and there were no clinical differences between those who tested positive or negative for M. genitalium, Dr. Wiesenfeld said.

The findings shed new light on the contributions of M. genitalium to cervicitis, but “at this point I do not think that these findings will change the routine management of cervicitis,” he said.

MONTREAL — Mycoplasma genitalium is probably an underrecognized cause of some cases of cervicitis, but the role of the physician in screening for and treating this organism remains unclear, according to Dr. Harold Wiesenfeld of Magee-Womens Hospital and the University of Pittsburgh.

Dr. Wiesenfeld outlined his work showing a link between M. genitalium and subclinical pelvic inflammatory disease, as well as more recent findings that implicate the organism in cervicitis, at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“Many cases, perhaps most cases, of cervicitis occur in women who are negative for the traditional pathogens known to cause cervicitis, such as Neisseria gonorrhoeae and Chlamydia trachomatis,” he said in an interview. “Our findings may explain the etiology of cervicitis in some women.”

His study of 524 women at risk for lower genital tract infection and undergoing testing for sexually transmitted disease found elevated polymorphonuclear leukocytes (PMNs), a microscopic marker for cervical inflammation, in 22% of the women.

M. genitalium was identified in 8% of the overall cohort, but occurred more frequently among those with elevated PMNs compared with those without (37% vs. 21%). In fact, among all women with elevated PMNs, M. genitalium was the most common pathogen “eclipsing the more traditionally recognized cervicitis organisms,” he said.

In contrast, only 32% of those with elevated PMNs had C. trachomatis, 22% had N. gonorrhoeae, 22% had bacterial vaginosis, and 21% had Trichomonas vaginalis.

After logistic regression, infection with M. genitalium was independently associated with elevated PMNs, with an odds ratio of 2.5, he said.

“As there is an independent association between M. genitalium and cervical inflammation, it is likely that M. genitalium is the cause of a true cervical infection rather than just a colonizing organism,” he said. “I would not expect a colonizing organism to cause a cervical inflammatory response.”

To rule out confounding STDs, the analysis was then restricted to 345 women who had tested negative for gonorrhea, chlamydia, and Trichomonas species. Eight percent of this cohort tested positive for M. genitalium, and 46% of this group had elevated PMNs compared with the 18 women who had no STD infections.

“After controlling for age, M. genitalium infection was independently associated with elevated PMNs with an odds ratio of 4.7,” he said.

Only a minority of women had clinical signs of cervicitis, and there were no clinical differences between those who tested positive or negative for M. genitalium, Dr. Wiesenfeld said.

The findings shed new light on the contributions of M. genitalium to cervicitis, but “at this point I do not think that these findings will change the routine management of cervicitis,” he said.

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Depression Worsens Impact of CVD Risk Factors in Women

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MONTREAL — In women with documented cardiovascular risk factors, those with comorbid depression have a greater risk of clinical events, compared with their nondepressed counterparts, according to new findings from the Women's Ischemic Syndrome Evaluation (WISE), trial sponsored by the National Heart, Lung, and Blood Institute.

“Many studies have associated depression with an increased risk of cardiovascular disease incidence, but until now, the predictive value of these risk factors has been unknown,” reported Thomas Rutledge, Ph.D., of the department of psychiatry at the University of California, San Diego.

“We wanted to know whether the added presence of depression would statistically worsen the relationship between cardiac risk factors and outcome,” he explained at the annual meeting of the Society of Behavioral Medicine.

Dr. Rutledge examined the association of cardiovascular disease (CVD) risk factors with actual CVD events in 153 depressed and 718 nondepressed women who were enrolled in the WISE trial. The women were a mean age of 60 years and all of them had been referred for coronary angiography because of symptoms suggestive of myocardial ischemia.

CVD risk factors were assessed, including smoking, dyslipidemia, hypertension, obesity, diabetes, and level of physical activity.

Depression was defined as self-reported current use of antidepressants to treat depression.

Over a mean follow-up period of 5.9 years, the CVD mortality rate was higher in depressed women with CVD risk factors than it was in nondepressed women with the same risk factors (11.5% vs. 9.2%, respectively). Similarly, depressed women experienced more cardiovascular events such as stroke, myocardial infarction, and heart failure (23.9% vs. 13.3%).

For four of the six individual CVD risk factors, “the combination of depression and the risk factor was associated with a significantly worse event rate, compared with the risk factor alone,” said Dr. Rutledge. “The exceptions were smoking and diabetes, but these were the two risk factors for which we had the smallest sample size, so power was possibly an issue.”

Excluding these exceptions, the combination of depression and risk factors was associated with an average 12%-13% increase in death and events, compared with risk factors alone, he said.

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MONTREAL — In women with documented cardiovascular risk factors, those with comorbid depression have a greater risk of clinical events, compared with their nondepressed counterparts, according to new findings from the Women's Ischemic Syndrome Evaluation (WISE), trial sponsored by the National Heart, Lung, and Blood Institute.

“Many studies have associated depression with an increased risk of cardiovascular disease incidence, but until now, the predictive value of these risk factors has been unknown,” reported Thomas Rutledge, Ph.D., of the department of psychiatry at the University of California, San Diego.

“We wanted to know whether the added presence of depression would statistically worsen the relationship between cardiac risk factors and outcome,” he explained at the annual meeting of the Society of Behavioral Medicine.

Dr. Rutledge examined the association of cardiovascular disease (CVD) risk factors with actual CVD events in 153 depressed and 718 nondepressed women who were enrolled in the WISE trial. The women were a mean age of 60 years and all of them had been referred for coronary angiography because of symptoms suggestive of myocardial ischemia.

CVD risk factors were assessed, including smoking, dyslipidemia, hypertension, obesity, diabetes, and level of physical activity.

Depression was defined as self-reported current use of antidepressants to treat depression.

Over a mean follow-up period of 5.9 years, the CVD mortality rate was higher in depressed women with CVD risk factors than it was in nondepressed women with the same risk factors (11.5% vs. 9.2%, respectively). Similarly, depressed women experienced more cardiovascular events such as stroke, myocardial infarction, and heart failure (23.9% vs. 13.3%).

For four of the six individual CVD risk factors, “the combination of depression and the risk factor was associated with a significantly worse event rate, compared with the risk factor alone,” said Dr. Rutledge. “The exceptions were smoking and diabetes, but these were the two risk factors for which we had the smallest sample size, so power was possibly an issue.”

Excluding these exceptions, the combination of depression and risk factors was associated with an average 12%-13% increase in death and events, compared with risk factors alone, he said.

MONTREAL — In women with documented cardiovascular risk factors, those with comorbid depression have a greater risk of clinical events, compared with their nondepressed counterparts, according to new findings from the Women's Ischemic Syndrome Evaluation (WISE), trial sponsored by the National Heart, Lung, and Blood Institute.

“Many studies have associated depression with an increased risk of cardiovascular disease incidence, but until now, the predictive value of these risk factors has been unknown,” reported Thomas Rutledge, Ph.D., of the department of psychiatry at the University of California, San Diego.

“We wanted to know whether the added presence of depression would statistically worsen the relationship between cardiac risk factors and outcome,” he explained at the annual meeting of the Society of Behavioral Medicine.

Dr. Rutledge examined the association of cardiovascular disease (CVD) risk factors with actual CVD events in 153 depressed and 718 nondepressed women who were enrolled in the WISE trial. The women were a mean age of 60 years and all of them had been referred for coronary angiography because of symptoms suggestive of myocardial ischemia.

CVD risk factors were assessed, including smoking, dyslipidemia, hypertension, obesity, diabetes, and level of physical activity.

Depression was defined as self-reported current use of antidepressants to treat depression.

Over a mean follow-up period of 5.9 years, the CVD mortality rate was higher in depressed women with CVD risk factors than it was in nondepressed women with the same risk factors (11.5% vs. 9.2%, respectively). Similarly, depressed women experienced more cardiovascular events such as stroke, myocardial infarction, and heart failure (23.9% vs. 13.3%).

For four of the six individual CVD risk factors, “the combination of depression and the risk factor was associated with a significantly worse event rate, compared with the risk factor alone,” said Dr. Rutledge. “The exceptions were smoking and diabetes, but these were the two risk factors for which we had the smallest sample size, so power was possibly an issue.”

Excluding these exceptions, the combination of depression and risk factors was associated with an average 12%-13% increase in death and events, compared with risk factors alone, he said.

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Depressed Patients May Not Follow Hypertension Regimen

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MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those who are not depressed or are in remission from depression, according to a study of 161 patients.

“This suggests that any change in depressive symptomatology over time can affect medication adherence and may be clinically important,” Sara Gallagher said at the annual meeting of the Society of Behavioral Medicine.

Her study was embedded in a randomized, controlled trial of the effect of motivational interviewing on medication adherence (Am. J. Hypertens. 2008;21:1137-43). The 161 hypertensive African Americans in the study were followed in primary care practice. The patients had a mean age of 54 years, and 87% of them were women. Depressive symptomatology was assessed at baseline and at 6 and 12 months using the Center for Epidemiologic Studies–Depression Scale (CES-D).

A total of 44% of the patients were classified as nondepressed, with a CES-D score of less than 16 at all time points, while 19% were considered depressed, with a score of 16 or above at all time points. The remaining 37% of the patients were classified as in remission, meaning that they progressed from depressed to nondepressed during of the study, said Ms. Gallagher, of New York (N.Y.) University.

Medication adherence was assessed at baseline and at 12 months using the self-reported Morisky scale. At baseline, 64% of the study population reported nonadherence to their medication, and this dropped to 48% at the end of the study.

A multivariate analysis revealed that depressive symptoms were associated with medication nonadherence, Ms. Gallagher reported.

Among the depressed patients, only 34% reported adherence at 12 months, compared with 66% of those in the nondepressed group and 47% of those who were in remission.

The study confirms previous findings that depressive symptoms are associated with poor medication adherence, Ms. Gallagher said. However, the finding that remission of depressive symptoms is associated with improved adherence suggests a benefit to addressing patient depression in this context, she said.

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MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those who are not depressed or are in remission from depression, according to a study of 161 patients.

“This suggests that any change in depressive symptomatology over time can affect medication adherence and may be clinically important,” Sara Gallagher said at the annual meeting of the Society of Behavioral Medicine.

Her study was embedded in a randomized, controlled trial of the effect of motivational interviewing on medication adherence (Am. J. Hypertens. 2008;21:1137-43). The 161 hypertensive African Americans in the study were followed in primary care practice. The patients had a mean age of 54 years, and 87% of them were women. Depressive symptomatology was assessed at baseline and at 6 and 12 months using the Center for Epidemiologic Studies–Depression Scale (CES-D).

A total of 44% of the patients were classified as nondepressed, with a CES-D score of less than 16 at all time points, while 19% were considered depressed, with a score of 16 or above at all time points. The remaining 37% of the patients were classified as in remission, meaning that they progressed from depressed to nondepressed during of the study, said Ms. Gallagher, of New York (N.Y.) University.

Medication adherence was assessed at baseline and at 12 months using the self-reported Morisky scale. At baseline, 64% of the study population reported nonadherence to their medication, and this dropped to 48% at the end of the study.

A multivariate analysis revealed that depressive symptoms were associated with medication nonadherence, Ms. Gallagher reported.

Among the depressed patients, only 34% reported adherence at 12 months, compared with 66% of those in the nondepressed group and 47% of those who were in remission.

The study confirms previous findings that depressive symptoms are associated with poor medication adherence, Ms. Gallagher said. However, the finding that remission of depressive symptoms is associated with improved adherence suggests a benefit to addressing patient depression in this context, she said.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those who are not depressed or are in remission from depression, according to a study of 161 patients.

“This suggests that any change in depressive symptomatology over time can affect medication adherence and may be clinically important,” Sara Gallagher said at the annual meeting of the Society of Behavioral Medicine.

Her study was embedded in a randomized, controlled trial of the effect of motivational interviewing on medication adherence (Am. J. Hypertens. 2008;21:1137-43). The 161 hypertensive African Americans in the study were followed in primary care practice. The patients had a mean age of 54 years, and 87% of them were women. Depressive symptomatology was assessed at baseline and at 6 and 12 months using the Center for Epidemiologic Studies–Depression Scale (CES-D).

A total of 44% of the patients were classified as nondepressed, with a CES-D score of less than 16 at all time points, while 19% were considered depressed, with a score of 16 or above at all time points. The remaining 37% of the patients were classified as in remission, meaning that they progressed from depressed to nondepressed during of the study, said Ms. Gallagher, of New York (N.Y.) University.

Medication adherence was assessed at baseline and at 12 months using the self-reported Morisky scale. At baseline, 64% of the study population reported nonadherence to their medication, and this dropped to 48% at the end of the study.

A multivariate analysis revealed that depressive symptoms were associated with medication nonadherence, Ms. Gallagher reported.

Among the depressed patients, only 34% reported adherence at 12 months, compared with 66% of those in the nondepressed group and 47% of those who were in remission.

The study confirms previous findings that depressive symptoms are associated with poor medication adherence, Ms. Gallagher said. However, the finding that remission of depressive symptoms is associated with improved adherence suggests a benefit to addressing patient depression in this context, she said.

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Anti-HIV Vaginal Gel Appears Safe and Persistent : These phase I data were from a single-center study of an experimental microbicide.

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MONTREAL — A single application of a vaginal microbicide gel resulted in persistently protective levels 24 hours later, with no significant side effects, reported Dr. Katherine Bunge of Magee-Womens Hospital in Pittsburgh.

These preliminary safety and persistence data justify daily dosing, she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The phase I, single-center trial of the nonnucleoside reverse transcription inhibitor UC-781 randomized 60 healthy women at a ratio of 2:1 to either treatment or placebo, explained Dr. Bunge, who had no disclosures to declare.

The women (mean age 26 years) also were randomized to product exposure durations of either 2, 4, or 8 hours. They received a physician-administered dose of vaginal gel and were then required to stay in the research facility for their assigned time period, after which specimens were collected by cervicovaginal lavage (CVL) and vaginal swabs. The subjects then returned 1 day, 1 week, and 1 month later for follow-up.

Urogenital irritation was assessed by pelvic exam and symptoms, microscopic genital changes were assessed by colposcopy, systemic safety was assessed by history and laboratory parameters, vaginal flora was quantified, and cervical cytokines were measured.

“These are fairly typical safety measures in any phase I trial of a microbicide, but what we attempted to do that hadn't really been looked at before was to figure out a way to determine the persistence of this vaginally applied drug that we didn't really expect to be absorbed,” she said.

To that end, plasma drug levels were measured both immediately after the patients' timed exposure and then again a day later; drug levels were measured in CVL and vaginal swab specimens, which also were collected at those two time points, Dr. Bunge explained.

At 24 hours post exposure, two patients had detectable levels of UC-781 in their plasma, but in both cases the levels were considered below the limits of quantification, she said.

In contrast, “the most important and interesting data” showed persistence of the drug in the vagina, she said. Eight hours after treatment, 100% of the women had detectable drug levels in CVL specimens and 90% had detectable levels in vaginal swab specimens. At 24 hours post exposure, 93% had detectable levels after a second CVL, and 42% showed detectable levels after a second vaginal swab.

Dr. Bunge pointed out that even after 24 hours, the median concentration of UC-781 in CVL specimens was 4,965 pmol/mL.

“The inhibitory concentration of UC-781 is 2 pmol/mL, so in fact at 24 hours after washout, the median concentration of detectable drug in CVL samples was a thousand times the inhibitory concentration,” she said.

Among the 197 adverse events (121 in the treatment group and 76 in the placebo group), 85% were classified as mild. There were four severe events but all were deemed not related or probably not related to treatment, said Dr. Bunge.

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MONTREAL — A single application of a vaginal microbicide gel resulted in persistently protective levels 24 hours later, with no significant side effects, reported Dr. Katherine Bunge of Magee-Womens Hospital in Pittsburgh.

These preliminary safety and persistence data justify daily dosing, she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The phase I, single-center trial of the nonnucleoside reverse transcription inhibitor UC-781 randomized 60 healthy women at a ratio of 2:1 to either treatment or placebo, explained Dr. Bunge, who had no disclosures to declare.

The women (mean age 26 years) also were randomized to product exposure durations of either 2, 4, or 8 hours. They received a physician-administered dose of vaginal gel and were then required to stay in the research facility for their assigned time period, after which specimens were collected by cervicovaginal lavage (CVL) and vaginal swabs. The subjects then returned 1 day, 1 week, and 1 month later for follow-up.

Urogenital irritation was assessed by pelvic exam and symptoms, microscopic genital changes were assessed by colposcopy, systemic safety was assessed by history and laboratory parameters, vaginal flora was quantified, and cervical cytokines were measured.

“These are fairly typical safety measures in any phase I trial of a microbicide, but what we attempted to do that hadn't really been looked at before was to figure out a way to determine the persistence of this vaginally applied drug that we didn't really expect to be absorbed,” she said.

To that end, plasma drug levels were measured both immediately after the patients' timed exposure and then again a day later; drug levels were measured in CVL and vaginal swab specimens, which also were collected at those two time points, Dr. Bunge explained.

At 24 hours post exposure, two patients had detectable levels of UC-781 in their plasma, but in both cases the levels were considered below the limits of quantification, she said.

In contrast, “the most important and interesting data” showed persistence of the drug in the vagina, she said. Eight hours after treatment, 100% of the women had detectable drug levels in CVL specimens and 90% had detectable levels in vaginal swab specimens. At 24 hours post exposure, 93% had detectable levels after a second CVL, and 42% showed detectable levels after a second vaginal swab.

Dr. Bunge pointed out that even after 24 hours, the median concentration of UC-781 in CVL specimens was 4,965 pmol/mL.

“The inhibitory concentration of UC-781 is 2 pmol/mL, so in fact at 24 hours after washout, the median concentration of detectable drug in CVL samples was a thousand times the inhibitory concentration,” she said.

Among the 197 adverse events (121 in the treatment group and 76 in the placebo group), 85% were classified as mild. There were four severe events but all were deemed not related or probably not related to treatment, said Dr. Bunge.

MONTREAL — A single application of a vaginal microbicide gel resulted in persistently protective levels 24 hours later, with no significant side effects, reported Dr. Katherine Bunge of Magee-Womens Hospital in Pittsburgh.

These preliminary safety and persistence data justify daily dosing, she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The phase I, single-center trial of the nonnucleoside reverse transcription inhibitor UC-781 randomized 60 healthy women at a ratio of 2:1 to either treatment or placebo, explained Dr. Bunge, who had no disclosures to declare.

The women (mean age 26 years) also were randomized to product exposure durations of either 2, 4, or 8 hours. They received a physician-administered dose of vaginal gel and were then required to stay in the research facility for their assigned time period, after which specimens were collected by cervicovaginal lavage (CVL) and vaginal swabs. The subjects then returned 1 day, 1 week, and 1 month later for follow-up.

Urogenital irritation was assessed by pelvic exam and symptoms, microscopic genital changes were assessed by colposcopy, systemic safety was assessed by history and laboratory parameters, vaginal flora was quantified, and cervical cytokines were measured.

“These are fairly typical safety measures in any phase I trial of a microbicide, but what we attempted to do that hadn't really been looked at before was to figure out a way to determine the persistence of this vaginally applied drug that we didn't really expect to be absorbed,” she said.

To that end, plasma drug levels were measured both immediately after the patients' timed exposure and then again a day later; drug levels were measured in CVL and vaginal swab specimens, which also were collected at those two time points, Dr. Bunge explained.

At 24 hours post exposure, two patients had detectable levels of UC-781 in their plasma, but in both cases the levels were considered below the limits of quantification, she said.

In contrast, “the most important and interesting data” showed persistence of the drug in the vagina, she said. Eight hours after treatment, 100% of the women had detectable drug levels in CVL specimens and 90% had detectable levels in vaginal swab specimens. At 24 hours post exposure, 93% had detectable levels after a second CVL, and 42% showed detectable levels after a second vaginal swab.

Dr. Bunge pointed out that even after 24 hours, the median concentration of UC-781 in CVL specimens was 4,965 pmol/mL.

“The inhibitory concentration of UC-781 is 2 pmol/mL, so in fact at 24 hours after washout, the median concentration of detectable drug in CVL samples was a thousand times the inhibitory concentration,” she said.

Among the 197 adverse events (121 in the treatment group and 76 in the placebo group), 85% were classified as mild. There were four severe events but all were deemed not related or probably not related to treatment, said Dr. Bunge.

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Cognitive Decline With Breast Ca May Be Rooted in Depression

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MONTREAL — Cognitive complaints in long-term breast cancer survivors might be better managed if issues of depression and fatigue are addressed, according to Heather McGinty, a doctoral student at the University South Florida in Tampa.

In a study that she presented at the annual meeting of the Society of Behavioral Medicine, Ms. McGinty showed that at 3 years after the end of breast cancer treatment, depression and fatigue were the strongest factors related to women's perceived cognitive decline.

“Perhaps women with these psychosocial issues are more vulnerable to cognitive problems,” she suggested.

The principal investigator on this study was Paul B. Jacobsen, Ph.D., of the H. Lee Moffitt Cancer Center in Tampa and the department of psychology at the University of South Florida.

The study included 216 women, with a mean age of 54 years, who had completed breast cancer treatment at least 3 years previously.

Roughly 90% of the women were postmenopausal, and all of them had received surgery: 55% for stage I disease; 35% for stage II; and 10% for stage 0.

In addition, half had received chemotherapy, either alone or in combination with radiotherapy.

Depression, fatigue, and perceived health were measured using the CES-D (Center for Epidemiologic Studies-Depression scale), the FSI (Fatigue Symptom Inventory), and the fatigue and general health subscales of the SF-36 (Medical Outcomes Study 36-Item Short Form Health Survey).

The participants also completed the MASQ (Multiple Abilities Self-Report Questionnaire) that measures perceived cognitive functioning across five cognitive domains, compared with that of same-age peers.

Sample statements about perceived cognitive functioning included: “After putting something away for safekeeping, I may not recall its location” (visual memory); “I can follow telephone conversations” (attention); “I can easily fit the pieces of a jigsaw puzzle together” (visual-perceptual ability); “I am able to recall the details of the evening news report several hours later” (verbal memory); and “I find myself calling a familiar object by the wrong name” (language), Ms. McGinty explained.

Overall, mean perceived cognitive function scores indicated that “these women were functioning quite well, reported rarely experiencing problems, and were frequently able to perform most tasks that were listed,” she said.

A particular combination of demographic, clinical, and psychosocial characteristics was associated with poorer cognitive functioning, however.

“Age, stage of diagnosis, surgery type, and tamoxifen use did not significantly correlate, but postmenopausal status, chemotherapy, depression, and fatigue were associated with worse cognition,” Ms. McGinty said.

“Interventions for fatigue and depression may have beneficial effects on perceived cognitive functioning in this patient population,” she noted.

“Neuropsychological testing may not always be sensitive to cancer-related changes, and lab-based measures may not correspond to people's experiences at home or at work,” Ms. McGinty said.

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MONTREAL — Cognitive complaints in long-term breast cancer survivors might be better managed if issues of depression and fatigue are addressed, according to Heather McGinty, a doctoral student at the University South Florida in Tampa.

In a study that she presented at the annual meeting of the Society of Behavioral Medicine, Ms. McGinty showed that at 3 years after the end of breast cancer treatment, depression and fatigue were the strongest factors related to women's perceived cognitive decline.

“Perhaps women with these psychosocial issues are more vulnerable to cognitive problems,” she suggested.

The principal investigator on this study was Paul B. Jacobsen, Ph.D., of the H. Lee Moffitt Cancer Center in Tampa and the department of psychology at the University of South Florida.

The study included 216 women, with a mean age of 54 years, who had completed breast cancer treatment at least 3 years previously.

Roughly 90% of the women were postmenopausal, and all of them had received surgery: 55% for stage I disease; 35% for stage II; and 10% for stage 0.

In addition, half had received chemotherapy, either alone or in combination with radiotherapy.

Depression, fatigue, and perceived health were measured using the CES-D (Center for Epidemiologic Studies-Depression scale), the FSI (Fatigue Symptom Inventory), and the fatigue and general health subscales of the SF-36 (Medical Outcomes Study 36-Item Short Form Health Survey).

The participants also completed the MASQ (Multiple Abilities Self-Report Questionnaire) that measures perceived cognitive functioning across five cognitive domains, compared with that of same-age peers.

Sample statements about perceived cognitive functioning included: “After putting something away for safekeeping, I may not recall its location” (visual memory); “I can follow telephone conversations” (attention); “I can easily fit the pieces of a jigsaw puzzle together” (visual-perceptual ability); “I am able to recall the details of the evening news report several hours later” (verbal memory); and “I find myself calling a familiar object by the wrong name” (language), Ms. McGinty explained.

Overall, mean perceived cognitive function scores indicated that “these women were functioning quite well, reported rarely experiencing problems, and were frequently able to perform most tasks that were listed,” she said.

A particular combination of demographic, clinical, and psychosocial characteristics was associated with poorer cognitive functioning, however.

“Age, stage of diagnosis, surgery type, and tamoxifen use did not significantly correlate, but postmenopausal status, chemotherapy, depression, and fatigue were associated with worse cognition,” Ms. McGinty said.

“Interventions for fatigue and depression may have beneficial effects on perceived cognitive functioning in this patient population,” she noted.

“Neuropsychological testing may not always be sensitive to cancer-related changes, and lab-based measures may not correspond to people's experiences at home or at work,” Ms. McGinty said.

MONTREAL — Cognitive complaints in long-term breast cancer survivors might be better managed if issues of depression and fatigue are addressed, according to Heather McGinty, a doctoral student at the University South Florida in Tampa.

In a study that she presented at the annual meeting of the Society of Behavioral Medicine, Ms. McGinty showed that at 3 years after the end of breast cancer treatment, depression and fatigue were the strongest factors related to women's perceived cognitive decline.

“Perhaps women with these psychosocial issues are more vulnerable to cognitive problems,” she suggested.

The principal investigator on this study was Paul B. Jacobsen, Ph.D., of the H. Lee Moffitt Cancer Center in Tampa and the department of psychology at the University of South Florida.

The study included 216 women, with a mean age of 54 years, who had completed breast cancer treatment at least 3 years previously.

Roughly 90% of the women were postmenopausal, and all of them had received surgery: 55% for stage I disease; 35% for stage II; and 10% for stage 0.

In addition, half had received chemotherapy, either alone or in combination with radiotherapy.

Depression, fatigue, and perceived health were measured using the CES-D (Center for Epidemiologic Studies-Depression scale), the FSI (Fatigue Symptom Inventory), and the fatigue and general health subscales of the SF-36 (Medical Outcomes Study 36-Item Short Form Health Survey).

The participants also completed the MASQ (Multiple Abilities Self-Report Questionnaire) that measures perceived cognitive functioning across five cognitive domains, compared with that of same-age peers.

Sample statements about perceived cognitive functioning included: “After putting something away for safekeeping, I may not recall its location” (visual memory); “I can follow telephone conversations” (attention); “I can easily fit the pieces of a jigsaw puzzle together” (visual-perceptual ability); “I am able to recall the details of the evening news report several hours later” (verbal memory); and “I find myself calling a familiar object by the wrong name” (language), Ms. McGinty explained.

Overall, mean perceived cognitive function scores indicated that “these women were functioning quite well, reported rarely experiencing problems, and were frequently able to perform most tasks that were listed,” she said.

A particular combination of demographic, clinical, and psychosocial characteristics was associated with poorer cognitive functioning, however.

“Age, stage of diagnosis, surgery type, and tamoxifen use did not significantly correlate, but postmenopausal status, chemotherapy, depression, and fatigue were associated with worse cognition,” Ms. McGinty said.

“Interventions for fatigue and depression may have beneficial effects on perceived cognitive functioning in this patient population,” she noted.

“Neuropsychological testing may not always be sensitive to cancer-related changes, and lab-based measures may not correspond to people's experiences at home or at work,” Ms. McGinty said.

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New Embryo Transfer Guidelines Expected Soon

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AMSTERDAM — New embryo transfer guidelines are expected soon from the American Society for Reproductive Medicine, prompted in part by the birth of the California octuplets earlier this year, according to Dr. David Adamson, immediate past president of the society.

The guidelines will “unquestionably lower the number of embryos transferred or modify how choices are made,” with the goal of further reducing the risk of multiple births, he said in an interview.

Despite considerable pressure to tighten the guidelines in the wake of the octuplets' delivery, the ASRM must carefully protect its vision of individualized patient treatment, Dr. Adamson said at the annual meeting of the European Society of Human Reproduction and Embryology.

“There certainly has been some perspective in the media and elsewhere that, because this occurred, there should be more regulation on the number of embryos transferred, but my perspective is that this was an extreme outlier and you don't want to make regulation based on extreme exceptions to the rule,” said Dr. Adamson, who is in private practice in Palo Alto, Calif. “It's impossible for any regulation, no matter how rigorous, to prevent sociopathic, psychopathic, illegal, or just plain crazy behavior.”

Nevertheless, the new guidelines, expected less than a year since the last ones were issued, reflect the ASRM's awareness of the need to tackle the problem of multiple births more aggressively.

While European experts released figures at the meeting showing that in 2006 twin deliveries resulting from assisted reproductive technologies in Europe dipped below 20% for the first time, the latest U.S. figures (2007) show the rate of IVF twin pregnancies at 33% in women under age 35, 28% in the 35- to 37-year-old age group, 22% in women aged 38–40, and 15% in the over 40 age group.

In the United States, elective single embryo transfer (SET) was performed in just 4.5% of cycles in women under age 35, dropping to 2.6% in women aged 35–37, 1% in those aged 38–40, and 0.3% in those over the age of 40.

In contrast, SET comprised 67% of all transfers in Sweden, where the practice is mandatory in women under age 40, said Dr. Adamson.

“But the average Swedish patient is 30 years old, and treatment is covered by the state,” he commented. “In the U.S. patients are 5 or 6 years older, they've had infertility for much longer, and they have to pay.”

Compared to laws and guidelines in many European countries, the current ASRM guidelines are more vague and less ambitious. For example, the ASRM guidelines simply state that “consideration should be given” to SET in women who are under the age of 35 and have a good chance of getting pregnant. But there is more emphasis placed on double embryo transfer, and the door is left open for the transfer of even more embryos, depending on the age of the patient and the prognosis.

While he said that the U.S. twin pregnancy rate following IVF needs to come down, Dr. Adamson added that this should not be at the cost of removing the ASRM's individualized approach to care.

“The risks are higher for twins and for their mothers, but they are not so high that twins are necessarily always a bad outcome. Clearly, the objective is a healthy singleton baby, but we have to make sure we don't reduce the overall quality of care by trying to make the twin rate 0% because that won't happen unless no one becomes pregnant,” he said.

Dr. Adamson receives research funding from Institut Biochimique SA and EMD Serono Inc.

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AMSTERDAM — New embryo transfer guidelines are expected soon from the American Society for Reproductive Medicine, prompted in part by the birth of the California octuplets earlier this year, according to Dr. David Adamson, immediate past president of the society.

The guidelines will “unquestionably lower the number of embryos transferred or modify how choices are made,” with the goal of further reducing the risk of multiple births, he said in an interview.

Despite considerable pressure to tighten the guidelines in the wake of the octuplets' delivery, the ASRM must carefully protect its vision of individualized patient treatment, Dr. Adamson said at the annual meeting of the European Society of Human Reproduction and Embryology.

“There certainly has been some perspective in the media and elsewhere that, because this occurred, there should be more regulation on the number of embryos transferred, but my perspective is that this was an extreme outlier and you don't want to make regulation based on extreme exceptions to the rule,” said Dr. Adamson, who is in private practice in Palo Alto, Calif. “It's impossible for any regulation, no matter how rigorous, to prevent sociopathic, psychopathic, illegal, or just plain crazy behavior.”

Nevertheless, the new guidelines, expected less than a year since the last ones were issued, reflect the ASRM's awareness of the need to tackle the problem of multiple births more aggressively.

While European experts released figures at the meeting showing that in 2006 twin deliveries resulting from assisted reproductive technologies in Europe dipped below 20% for the first time, the latest U.S. figures (2007) show the rate of IVF twin pregnancies at 33% in women under age 35, 28% in the 35- to 37-year-old age group, 22% in women aged 38–40, and 15% in the over 40 age group.

In the United States, elective single embryo transfer (SET) was performed in just 4.5% of cycles in women under age 35, dropping to 2.6% in women aged 35–37, 1% in those aged 38–40, and 0.3% in those over the age of 40.

In contrast, SET comprised 67% of all transfers in Sweden, where the practice is mandatory in women under age 40, said Dr. Adamson.

“But the average Swedish patient is 30 years old, and treatment is covered by the state,” he commented. “In the U.S. patients are 5 or 6 years older, they've had infertility for much longer, and they have to pay.”

Compared to laws and guidelines in many European countries, the current ASRM guidelines are more vague and less ambitious. For example, the ASRM guidelines simply state that “consideration should be given” to SET in women who are under the age of 35 and have a good chance of getting pregnant. But there is more emphasis placed on double embryo transfer, and the door is left open for the transfer of even more embryos, depending on the age of the patient and the prognosis.

While he said that the U.S. twin pregnancy rate following IVF needs to come down, Dr. Adamson added that this should not be at the cost of removing the ASRM's individualized approach to care.

“The risks are higher for twins and for their mothers, but they are not so high that twins are necessarily always a bad outcome. Clearly, the objective is a healthy singleton baby, but we have to make sure we don't reduce the overall quality of care by trying to make the twin rate 0% because that won't happen unless no one becomes pregnant,” he said.

Dr. Adamson receives research funding from Institut Biochimique SA and EMD Serono Inc.

AMSTERDAM — New embryo transfer guidelines are expected soon from the American Society for Reproductive Medicine, prompted in part by the birth of the California octuplets earlier this year, according to Dr. David Adamson, immediate past president of the society.

The guidelines will “unquestionably lower the number of embryos transferred or modify how choices are made,” with the goal of further reducing the risk of multiple births, he said in an interview.

Despite considerable pressure to tighten the guidelines in the wake of the octuplets' delivery, the ASRM must carefully protect its vision of individualized patient treatment, Dr. Adamson said at the annual meeting of the European Society of Human Reproduction and Embryology.

“There certainly has been some perspective in the media and elsewhere that, because this occurred, there should be more regulation on the number of embryos transferred, but my perspective is that this was an extreme outlier and you don't want to make regulation based on extreme exceptions to the rule,” said Dr. Adamson, who is in private practice in Palo Alto, Calif. “It's impossible for any regulation, no matter how rigorous, to prevent sociopathic, psychopathic, illegal, or just plain crazy behavior.”

Nevertheless, the new guidelines, expected less than a year since the last ones were issued, reflect the ASRM's awareness of the need to tackle the problem of multiple births more aggressively.

While European experts released figures at the meeting showing that in 2006 twin deliveries resulting from assisted reproductive technologies in Europe dipped below 20% for the first time, the latest U.S. figures (2007) show the rate of IVF twin pregnancies at 33% in women under age 35, 28% in the 35- to 37-year-old age group, 22% in women aged 38–40, and 15% in the over 40 age group.

In the United States, elective single embryo transfer (SET) was performed in just 4.5% of cycles in women under age 35, dropping to 2.6% in women aged 35–37, 1% in those aged 38–40, and 0.3% in those over the age of 40.

In contrast, SET comprised 67% of all transfers in Sweden, where the practice is mandatory in women under age 40, said Dr. Adamson.

“But the average Swedish patient is 30 years old, and treatment is covered by the state,” he commented. “In the U.S. patients are 5 or 6 years older, they've had infertility for much longer, and they have to pay.”

Compared to laws and guidelines in many European countries, the current ASRM guidelines are more vague and less ambitious. For example, the ASRM guidelines simply state that “consideration should be given” to SET in women who are under the age of 35 and have a good chance of getting pregnant. But there is more emphasis placed on double embryo transfer, and the door is left open for the transfer of even more embryos, depending on the age of the patient and the prognosis.

While he said that the U.S. twin pregnancy rate following IVF needs to come down, Dr. Adamson added that this should not be at the cost of removing the ASRM's individualized approach to care.

“The risks are higher for twins and for their mothers, but they are not so high that twins are necessarily always a bad outcome. Clearly, the objective is a healthy singleton baby, but we have to make sure we don't reduce the overall quality of care by trying to make the twin rate 0% because that won't happen unless no one becomes pregnant,” he said.

Dr. Adamson receives research funding from Institut Biochimique SA and EMD Serono Inc.

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Foreign Fertility Patients Boost U.S. Business

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AMSTERDAM — A bright light in the floundering U.S. economy may be an influx of foreign fertility patients, several experts suggested.

Last year, up to 5,000 patients seeking fertility treatment—8% of the national U.S. annual volume—came to the U.S. from abroad, with European and Latin American populations comprising the bulk of those patients, according to study findings from a survey of American and Canadian fertility clinics conducted in October 2008 that were presented at the annual meeting of the European Society of Human Reproduction and Embryology.

“There is significant transatlantic traffic of patients to the U.S,” said the study's lead author, Dr. Edward Hughes from McMaster University in Hamilton, Ontario, Canada. These patients are seeking conventional in vitro fertilization (IVF), as well as anonymous egg donation and gestational carriers.

The influx is thanks to a glut of European patients, attracted by the faltering U.S. dollar as well as by less restrictive access to certain treatments, particularly third-party reproduction, according Dr. Brian Kaplan, a reproductive endocrinologist with Fertility Centers of Illinois in the Chicago area.

“There are favorable laws in the U.S. compared with many European countries, which have banned certain treatments. Combine this with the excellent pregnancy rates at our center, and most of the centers in the U.S., and the fact that U.S. fees are more attractive because of the recession, and that's why they're coming,” Dr. Kaplan said in an interview.

Although U.S. fees have traditionally been, and remain considerably higher than those in many European countries, they are offset by better success rates and access, he emphasized.

Indeed, the U.S. has always been an attractive choice for many foreign infertile couples hampered by restrictions they face at home, says Dr. David Adamson, immediate past president of the American Society for Reproductive Medicine.

“Patients with infertility will do almost anything they can to have a family. If a country has a situation where a large number of citizens are deciding to go elsewhere for care, then it's very important for that country to look at the reasons and to decide if their regulations are appropriate or not,” he said in an interview.

A good example is the recent influx of Canadian patients across the U.S. border. According to the survey, the U.S. received 7% of Canada's national volume of in vitro fertilization patients last year. A full 80% of those patients were seeking egg donation, which has become virtually unavailable in their own country since a ban on payment to donors, said Dr. Hughes.

“If a patient in Canada has an altruistic donor she can certainly have care, but in the absence of that, donor egg patients have been traveling to the States in increasing numbers,” he said.

The economy may also be providing additional incentives in this context, as more U.S. women are considering egg donation as a means to supplement their income.

“Clinics are reporting a surge in egg donors as a result of the economic climate,” reported Wendy Kramer from the Donor Sibling Registry. She cited a Wall Street Journal headline from last December, which read “Women Line Up to Donate Eggs—for Money.”

Regardless of the economy, cross-border fertility “tourism” is a growing reality that will continue to flourish as long as countries differ regarding regulation and access, Dr. Adamson said.

“One can expect in the future there will probably be slow harmonization of legislation, guidelines, and oversight, but I don't see that there will be complete unanimity for decades and decades to come—if ever,” he said.

The survey was a joint effort of Assisted Human Reproduction Canada, and the U.S. Society for Assisted Reproductive Technology.

It involved the polling of 392 U.S. and 34 Canadian fertility providers. A total of 125 (32%) U.S. providers responded, and it was estimated that they were responsible for providing about 42% of national fertility services, said Dr. Hughes. The Canadian response rate was 82%, representing 77% of that country's fertility services.

U.S. clinics reported a total of 1,809 patients entering the country for treatment, 1,400 for IVF. “That's about 4% of the national volume, but in absolute terms these numbers need to at least be doubled,” he said, explaining that the responders provided less than half of the fertility services in the country. “There are probably 5,000 incoming patients, about 3,000 of them for IVF,” he concluded.

Regardless of the economy, cross-border fertility 'tourism' is a growing reality that will continue to flourish.

Source DR. ADAMSON

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AMSTERDAM — A bright light in the floundering U.S. economy may be an influx of foreign fertility patients, several experts suggested.

Last year, up to 5,000 patients seeking fertility treatment—8% of the national U.S. annual volume—came to the U.S. from abroad, with European and Latin American populations comprising the bulk of those patients, according to study findings from a survey of American and Canadian fertility clinics conducted in October 2008 that were presented at the annual meeting of the European Society of Human Reproduction and Embryology.

“There is significant transatlantic traffic of patients to the U.S,” said the study's lead author, Dr. Edward Hughes from McMaster University in Hamilton, Ontario, Canada. These patients are seeking conventional in vitro fertilization (IVF), as well as anonymous egg donation and gestational carriers.

The influx is thanks to a glut of European patients, attracted by the faltering U.S. dollar as well as by less restrictive access to certain treatments, particularly third-party reproduction, according Dr. Brian Kaplan, a reproductive endocrinologist with Fertility Centers of Illinois in the Chicago area.

“There are favorable laws in the U.S. compared with many European countries, which have banned certain treatments. Combine this with the excellent pregnancy rates at our center, and most of the centers in the U.S., and the fact that U.S. fees are more attractive because of the recession, and that's why they're coming,” Dr. Kaplan said in an interview.

Although U.S. fees have traditionally been, and remain considerably higher than those in many European countries, they are offset by better success rates and access, he emphasized.

Indeed, the U.S. has always been an attractive choice for many foreign infertile couples hampered by restrictions they face at home, says Dr. David Adamson, immediate past president of the American Society for Reproductive Medicine.

“Patients with infertility will do almost anything they can to have a family. If a country has a situation where a large number of citizens are deciding to go elsewhere for care, then it's very important for that country to look at the reasons and to decide if their regulations are appropriate or not,” he said in an interview.

A good example is the recent influx of Canadian patients across the U.S. border. According to the survey, the U.S. received 7% of Canada's national volume of in vitro fertilization patients last year. A full 80% of those patients were seeking egg donation, which has become virtually unavailable in their own country since a ban on payment to donors, said Dr. Hughes.

“If a patient in Canada has an altruistic donor she can certainly have care, but in the absence of that, donor egg patients have been traveling to the States in increasing numbers,” he said.

The economy may also be providing additional incentives in this context, as more U.S. women are considering egg donation as a means to supplement their income.

“Clinics are reporting a surge in egg donors as a result of the economic climate,” reported Wendy Kramer from the Donor Sibling Registry. She cited a Wall Street Journal headline from last December, which read “Women Line Up to Donate Eggs—for Money.”

Regardless of the economy, cross-border fertility “tourism” is a growing reality that will continue to flourish as long as countries differ regarding regulation and access, Dr. Adamson said.

“One can expect in the future there will probably be slow harmonization of legislation, guidelines, and oversight, but I don't see that there will be complete unanimity for decades and decades to come—if ever,” he said.

The survey was a joint effort of Assisted Human Reproduction Canada, and the U.S. Society for Assisted Reproductive Technology.

It involved the polling of 392 U.S. and 34 Canadian fertility providers. A total of 125 (32%) U.S. providers responded, and it was estimated that they were responsible for providing about 42% of national fertility services, said Dr. Hughes. The Canadian response rate was 82%, representing 77% of that country's fertility services.

U.S. clinics reported a total of 1,809 patients entering the country for treatment, 1,400 for IVF. “That's about 4% of the national volume, but in absolute terms these numbers need to at least be doubled,” he said, explaining that the responders provided less than half of the fertility services in the country. “There are probably 5,000 incoming patients, about 3,000 of them for IVF,” he concluded.

Regardless of the economy, cross-border fertility 'tourism' is a growing reality that will continue to flourish.

Source DR. ADAMSON

AMSTERDAM — A bright light in the floundering U.S. economy may be an influx of foreign fertility patients, several experts suggested.

Last year, up to 5,000 patients seeking fertility treatment—8% of the national U.S. annual volume—came to the U.S. from abroad, with European and Latin American populations comprising the bulk of those patients, according to study findings from a survey of American and Canadian fertility clinics conducted in October 2008 that were presented at the annual meeting of the European Society of Human Reproduction and Embryology.

“There is significant transatlantic traffic of patients to the U.S,” said the study's lead author, Dr. Edward Hughes from McMaster University in Hamilton, Ontario, Canada. These patients are seeking conventional in vitro fertilization (IVF), as well as anonymous egg donation and gestational carriers.

The influx is thanks to a glut of European patients, attracted by the faltering U.S. dollar as well as by less restrictive access to certain treatments, particularly third-party reproduction, according Dr. Brian Kaplan, a reproductive endocrinologist with Fertility Centers of Illinois in the Chicago area.

“There are favorable laws in the U.S. compared with many European countries, which have banned certain treatments. Combine this with the excellent pregnancy rates at our center, and most of the centers in the U.S., and the fact that U.S. fees are more attractive because of the recession, and that's why they're coming,” Dr. Kaplan said in an interview.

Although U.S. fees have traditionally been, and remain considerably higher than those in many European countries, they are offset by better success rates and access, he emphasized.

Indeed, the U.S. has always been an attractive choice for many foreign infertile couples hampered by restrictions they face at home, says Dr. David Adamson, immediate past president of the American Society for Reproductive Medicine.

“Patients with infertility will do almost anything they can to have a family. If a country has a situation where a large number of citizens are deciding to go elsewhere for care, then it's very important for that country to look at the reasons and to decide if their regulations are appropriate or not,” he said in an interview.

A good example is the recent influx of Canadian patients across the U.S. border. According to the survey, the U.S. received 7% of Canada's national volume of in vitro fertilization patients last year. A full 80% of those patients were seeking egg donation, which has become virtually unavailable in their own country since a ban on payment to donors, said Dr. Hughes.

“If a patient in Canada has an altruistic donor she can certainly have care, but in the absence of that, donor egg patients have been traveling to the States in increasing numbers,” he said.

The economy may also be providing additional incentives in this context, as more U.S. women are considering egg donation as a means to supplement their income.

“Clinics are reporting a surge in egg donors as a result of the economic climate,” reported Wendy Kramer from the Donor Sibling Registry. She cited a Wall Street Journal headline from last December, which read “Women Line Up to Donate Eggs—for Money.”

Regardless of the economy, cross-border fertility “tourism” is a growing reality that will continue to flourish as long as countries differ regarding regulation and access, Dr. Adamson said.

“One can expect in the future there will probably be slow harmonization of legislation, guidelines, and oversight, but I don't see that there will be complete unanimity for decades and decades to come—if ever,” he said.

The survey was a joint effort of Assisted Human Reproduction Canada, and the U.S. Society for Assisted Reproductive Technology.

It involved the polling of 392 U.S. and 34 Canadian fertility providers. A total of 125 (32%) U.S. providers responded, and it was estimated that they were responsible for providing about 42% of national fertility services, said Dr. Hughes. The Canadian response rate was 82%, representing 77% of that country's fertility services.

U.S. clinics reported a total of 1,809 patients entering the country for treatment, 1,400 for IVF. “That's about 4% of the national volume, but in absolute terms these numbers need to at least be doubled,” he said, explaining that the responders provided less than half of the fertility services in the country. “There are probably 5,000 incoming patients, about 3,000 of them for IVF,” he concluded.

Regardless of the economy, cross-border fertility 'tourism' is a growing reality that will continue to flourish.

Source DR. ADAMSON

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