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Endometrial scratching prior to a fresh embryo or frozen embryo transfer did not result in a higher rate of live births for women undergoing in vitro fertilization (IVF), according to results from a recent randomized controlled trial published in the New England Journal of Medicine.
Sarah Lensen, PhD, of the University of Auckland in New Zealand, and her colleagues recruited 1,364 women from 13 sites in 5 countries in 2014-2017 who did not have a recent history of disruptive intrauterine instrumentation such as hysteroscopy or endometrial biopsy and were planning an IVF cycle with a fresh or frozen embryo transfer. The women were randomized to receive endometrial scratching through pipelle biopsy between day 3 of the cycle prior to IVF and day 3 of the IVF cycle. Live birth was the primary outcome, while secondary outcomes measured included ongoing pregnancy, clinical pregnancy, multiple pregnancy, ectopic pregnancy, and biochemical pregnancy, as well as miscarriage, termination of pregnancy, stillbirth, and other maternal and neonatal outcomes.
For the endometrial scratch group, the rate of live birth was 26% (180 of 690 women), compared with 26% (176 of 674 women) in the control group (adjusted odds ratio, 1.00; 95% confidence interval, 0.78-1.27, P = .97). The rate of ongoing pregnancy, clinical pregnancy, ectopic pregnancy, and miscarriage also did not significantly differ between groups.
Among women who underwent endometrial scratching, there was a median pain score of 3.5 points from a range of 0-10 points; 37 women reported a pain scale score of 0, while 6 said their pain score was a 10. Adverse reactions to endometrial scratching included fainting, dizziness and/or nausea (7 women); excessive pain (5 women), including 1 woman who went to the emergency department after a concurrent endometrial scratch and sonohysterogram procedure; and excessive bleeding (2 women).
The researchers noted several limitations in their study, including its unblinded design; tracking of adverse outcomes in the endometrial scratch group only; and a definition of implantation failure not based on embryo or transfer quality, but on the number of previous unsuccessful transfers. There were also “imbalances favoring the endometrial scratch group” based on the number of available oocytes per participant and willingness to begin their IVF cycle.
“Women in the endometrial scratch group may have been more likely to start their cycle in order to capitalize on their exposure to the endometrial scratch. However, results were materially unchanged in a per-protocol analysis,” the researchers said.
This study was funded in part by the University of Auckland, the A+ Trust, Auckland District Health Board, the Nurture Foundation, and the Maurice and Phyllis Paykel Trust. Dr. Priya Bhide received personal fees from Ferring Pharmaceuticals, and grants from Bart’s Charity, Pharmasure Pharmaceuticals, and Finox Pharmaceuticals. The other authors reported no relevant financial disclosures.
SOURCE: Lensen S et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1808737.
The results of a large, pragmatic trial by Lensen et al., examining the effects of endometrial scratching, which used current standards of care for in vitro fertilization (IVF) and included women undergoing treatment for the first time in addition to those who have had previously failed cycles, should be trusted despite contrary data from other studies, Ben W. Mol, MD, PhD, and Kurt T. Barnhart, MD, MSCE, wrote in a related editorial.
Although a Cochrane systematic review of 14 randomized controlled trials found evidence of an increased live birth rate for women undergoing IVF after an endometrial scratch procedure (risk ratio, 1.42; 95% confidence interval, 1.08-1.85), many trials in the meta-analysis had “unrealistic” large effect sizes within limited sample sizes, were not optimally randomized, were stopped prematurely, or were not prospectively registered, they noted.
“Rigorous synthesis of bad data cannot overcome bias from uncontrolled or poorly conducted studies; it may result only in tighter confidence around a spurious conclusion, an answer that is precisely wrong,” they said.
However, as the results from Lensen et al. show, there were a low number of reported adverse events, and “on the basis of the current report, the IVF community can take solace in the observation that ‘scratching’ apparently caused no harm, other than some procedure-associated pain and bleeding.”
Any adjuvant to IVF should be “evaluated carefully before being offered to infertility couples” and it is still an unanswered question as to whether IVF doctors should continue to offer unevaluated adjuvants to their patients, Dr. Mol and Dr. Barnhart said.
“The population affected by infertility has been described as vulnerable. The goals of reproductive medicine are the same as those of other fields of medicine: Provide compassionate and effective care, do no harm, and do not offer false hope or sell snake oil,” the authors concluded.
Dr. Mol is at Monash University in Clayton, Australia, and Dr. Barnhart is at the University of Pennsylvania in Philadelphia. This commentary summarizes their editorial on the study by Lensen et al. (N Eng J Med. 2019. doi: 10.1056/NEJMe1815042 ). Dr. Mol disclosed ties with Merck, Guerbet, and ObsEva, outside the submitted work. Dr. Barnhart had no relevant disclosures.
The results of a large, pragmatic trial by Lensen et al., examining the effects of endometrial scratching, which used current standards of care for in vitro fertilization (IVF) and included women undergoing treatment for the first time in addition to those who have had previously failed cycles, should be trusted despite contrary data from other studies, Ben W. Mol, MD, PhD, and Kurt T. Barnhart, MD, MSCE, wrote in a related editorial.
Although a Cochrane systematic review of 14 randomized controlled trials found evidence of an increased live birth rate for women undergoing IVF after an endometrial scratch procedure (risk ratio, 1.42; 95% confidence interval, 1.08-1.85), many trials in the meta-analysis had “unrealistic” large effect sizes within limited sample sizes, were not optimally randomized, were stopped prematurely, or were not prospectively registered, they noted.
“Rigorous synthesis of bad data cannot overcome bias from uncontrolled or poorly conducted studies; it may result only in tighter confidence around a spurious conclusion, an answer that is precisely wrong,” they said.
However, as the results from Lensen et al. show, there were a low number of reported adverse events, and “on the basis of the current report, the IVF community can take solace in the observation that ‘scratching’ apparently caused no harm, other than some procedure-associated pain and bleeding.”
Any adjuvant to IVF should be “evaluated carefully before being offered to infertility couples” and it is still an unanswered question as to whether IVF doctors should continue to offer unevaluated adjuvants to their patients, Dr. Mol and Dr. Barnhart said.
“The population affected by infertility has been described as vulnerable. The goals of reproductive medicine are the same as those of other fields of medicine: Provide compassionate and effective care, do no harm, and do not offer false hope or sell snake oil,” the authors concluded.
Dr. Mol is at Monash University in Clayton, Australia, and Dr. Barnhart is at the University of Pennsylvania in Philadelphia. This commentary summarizes their editorial on the study by Lensen et al. (N Eng J Med. 2019. doi: 10.1056/NEJMe1815042 ). Dr. Mol disclosed ties with Merck, Guerbet, and ObsEva, outside the submitted work. Dr. Barnhart had no relevant disclosures.
The results of a large, pragmatic trial by Lensen et al., examining the effects of endometrial scratching, which used current standards of care for in vitro fertilization (IVF) and included women undergoing treatment for the first time in addition to those who have had previously failed cycles, should be trusted despite contrary data from other studies, Ben W. Mol, MD, PhD, and Kurt T. Barnhart, MD, MSCE, wrote in a related editorial.
Although a Cochrane systematic review of 14 randomized controlled trials found evidence of an increased live birth rate for women undergoing IVF after an endometrial scratch procedure (risk ratio, 1.42; 95% confidence interval, 1.08-1.85), many trials in the meta-analysis had “unrealistic” large effect sizes within limited sample sizes, were not optimally randomized, were stopped prematurely, or were not prospectively registered, they noted.
“Rigorous synthesis of bad data cannot overcome bias from uncontrolled or poorly conducted studies; it may result only in tighter confidence around a spurious conclusion, an answer that is precisely wrong,” they said.
However, as the results from Lensen et al. show, there were a low number of reported adverse events, and “on the basis of the current report, the IVF community can take solace in the observation that ‘scratching’ apparently caused no harm, other than some procedure-associated pain and bleeding.”
Any adjuvant to IVF should be “evaluated carefully before being offered to infertility couples” and it is still an unanswered question as to whether IVF doctors should continue to offer unevaluated adjuvants to their patients, Dr. Mol and Dr. Barnhart said.
“The population affected by infertility has been described as vulnerable. The goals of reproductive medicine are the same as those of other fields of medicine: Provide compassionate and effective care, do no harm, and do not offer false hope or sell snake oil,” the authors concluded.
Dr. Mol is at Monash University in Clayton, Australia, and Dr. Barnhart is at the University of Pennsylvania in Philadelphia. This commentary summarizes their editorial on the study by Lensen et al. (N Eng J Med. 2019. doi: 10.1056/NEJMe1815042 ). Dr. Mol disclosed ties with Merck, Guerbet, and ObsEva, outside the submitted work. Dr. Barnhart had no relevant disclosures.
Endometrial scratching prior to a fresh embryo or frozen embryo transfer did not result in a higher rate of live births for women undergoing in vitro fertilization (IVF), according to results from a recent randomized controlled trial published in the New England Journal of Medicine.
Sarah Lensen, PhD, of the University of Auckland in New Zealand, and her colleagues recruited 1,364 women from 13 sites in 5 countries in 2014-2017 who did not have a recent history of disruptive intrauterine instrumentation such as hysteroscopy or endometrial biopsy and were planning an IVF cycle with a fresh or frozen embryo transfer. The women were randomized to receive endometrial scratching through pipelle biopsy between day 3 of the cycle prior to IVF and day 3 of the IVF cycle. Live birth was the primary outcome, while secondary outcomes measured included ongoing pregnancy, clinical pregnancy, multiple pregnancy, ectopic pregnancy, and biochemical pregnancy, as well as miscarriage, termination of pregnancy, stillbirth, and other maternal and neonatal outcomes.
For the endometrial scratch group, the rate of live birth was 26% (180 of 690 women), compared with 26% (176 of 674 women) in the control group (adjusted odds ratio, 1.00; 95% confidence interval, 0.78-1.27, P = .97). The rate of ongoing pregnancy, clinical pregnancy, ectopic pregnancy, and miscarriage also did not significantly differ between groups.
Among women who underwent endometrial scratching, there was a median pain score of 3.5 points from a range of 0-10 points; 37 women reported a pain scale score of 0, while 6 said their pain score was a 10. Adverse reactions to endometrial scratching included fainting, dizziness and/or nausea (7 women); excessive pain (5 women), including 1 woman who went to the emergency department after a concurrent endometrial scratch and sonohysterogram procedure; and excessive bleeding (2 women).
The researchers noted several limitations in their study, including its unblinded design; tracking of adverse outcomes in the endometrial scratch group only; and a definition of implantation failure not based on embryo or transfer quality, but on the number of previous unsuccessful transfers. There were also “imbalances favoring the endometrial scratch group” based on the number of available oocytes per participant and willingness to begin their IVF cycle.
“Women in the endometrial scratch group may have been more likely to start their cycle in order to capitalize on their exposure to the endometrial scratch. However, results were materially unchanged in a per-protocol analysis,” the researchers said.
This study was funded in part by the University of Auckland, the A+ Trust, Auckland District Health Board, the Nurture Foundation, and the Maurice and Phyllis Paykel Trust. Dr. Priya Bhide received personal fees from Ferring Pharmaceuticals, and grants from Bart’s Charity, Pharmasure Pharmaceuticals, and Finox Pharmaceuticals. The other authors reported no relevant financial disclosures.
SOURCE: Lensen S et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1808737.
Endometrial scratching prior to a fresh embryo or frozen embryo transfer did not result in a higher rate of live births for women undergoing in vitro fertilization (IVF), according to results from a recent randomized controlled trial published in the New England Journal of Medicine.
Sarah Lensen, PhD, of the University of Auckland in New Zealand, and her colleagues recruited 1,364 women from 13 sites in 5 countries in 2014-2017 who did not have a recent history of disruptive intrauterine instrumentation such as hysteroscopy or endometrial biopsy and were planning an IVF cycle with a fresh or frozen embryo transfer. The women were randomized to receive endometrial scratching through pipelle biopsy between day 3 of the cycle prior to IVF and day 3 of the IVF cycle. Live birth was the primary outcome, while secondary outcomes measured included ongoing pregnancy, clinical pregnancy, multiple pregnancy, ectopic pregnancy, and biochemical pregnancy, as well as miscarriage, termination of pregnancy, stillbirth, and other maternal and neonatal outcomes.
For the endometrial scratch group, the rate of live birth was 26% (180 of 690 women), compared with 26% (176 of 674 women) in the control group (adjusted odds ratio, 1.00; 95% confidence interval, 0.78-1.27, P = .97). The rate of ongoing pregnancy, clinical pregnancy, ectopic pregnancy, and miscarriage also did not significantly differ between groups.
Among women who underwent endometrial scratching, there was a median pain score of 3.5 points from a range of 0-10 points; 37 women reported a pain scale score of 0, while 6 said their pain score was a 10. Adverse reactions to endometrial scratching included fainting, dizziness and/or nausea (7 women); excessive pain (5 women), including 1 woman who went to the emergency department after a concurrent endometrial scratch and sonohysterogram procedure; and excessive bleeding (2 women).
The researchers noted several limitations in their study, including its unblinded design; tracking of adverse outcomes in the endometrial scratch group only; and a definition of implantation failure not based on embryo or transfer quality, but on the number of previous unsuccessful transfers. There were also “imbalances favoring the endometrial scratch group” based on the number of available oocytes per participant and willingness to begin their IVF cycle.
“Women in the endometrial scratch group may have been more likely to start their cycle in order to capitalize on their exposure to the endometrial scratch. However, results were materially unchanged in a per-protocol analysis,” the researchers said.
This study was funded in part by the University of Auckland, the A+ Trust, Auckland District Health Board, the Nurture Foundation, and the Maurice and Phyllis Paykel Trust. Dr. Priya Bhide received personal fees from Ferring Pharmaceuticals, and grants from Bart’s Charity, Pharmasure Pharmaceuticals, and Finox Pharmaceuticals. The other authors reported no relevant financial disclosures.
SOURCE: Lensen S et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1808737.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: The live birth rate for women in the endometrial scratch group was 26% of 690 participants, compared with 26% of 674 women in the control group, a nonsignificant difference.
Study details: A multicenter, open-label, randomized controlled trial of 1,364 women undergoing IVF at 13 different sites in 5 countries.
Disclosures: This study was funded in part by the University of Auckland, the A+ Trust, Auckland District Health Board, the Nurture Foundation, and the Maurice and Phyllis Paykel Trust. Dr. Priya Bhide received personal fees from Ferring Pharmaceuticals, and grants from Bart’s Charity, Pharmasure Pharmaceuticals, and Finox Pharmaceuticals. The other authors reported no relevant financial disclosures.
Source: Lensen S et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1808737.