No higher live birth rate with pre-FIV endometrial scraping

Author CME: Vicki Brower

Authors of the studySarah Lensen, Diana Osavlyuk, et al.

Target audience and target statement:

Obstetricians / Gynecologists and Assisted Fertility Specialists

The goal was to determine whether endometrial scrapes prior to in vitro fertilization (IVF) resulted in higher rates of embryo implantation, pregnancy, and live births compared to the absence of intervention.

Question addressed:

• Does scraping the endometrium before IVF increase the chances of birth in women (primary endpoint)?
• Does this procedure result in ongoing pregnancy, clinical pregnancy, multiple pregnancies, ectopic pregnancy, biochemical pregnancy, miscarriage, stillbirth, miscarriage, pain during the procedure, bleeding the day after the procedure and maternal and neonatal outcomes (secondary endpoints)?

Summary and perspective of the study:

According to an important international randomized trial, endometrial scrapes before in vitro fertilization (IVF), although intended to improve pregnancy rates, did not improve live birth rates without treatment in any subgroup.

Sarah Lensen, Ph.D., from the University of Auckland, New Zealand, and her colleagues, said the intervention produced a live birth for 26.1% of women, compared to 26.1% of women. , 1% of controls (OR adjusted 1.00, 95% CI 0.78-1.27).

In addition, there were no significant differences in other outcomes of pregnancy, such as clinically confirmed pregnancy, ectopic pregnancy, or miscarriage rates, the authors wrote. New England Journal of Medicine. The current results are in line with what the same researchers presented at the meeting of the European Society of Human Reproduction and Embryology of 2018 in Barcelona.

Lensen and colleagues randomized 1,364 women over 3 years to 13 sites (2014-2017): 690 experienced endometrial scarring from the 3rd day of the cycle preceding the IVF cycle and the 3rd day of the cycle IVF, and 674 served as witnesses. Twenty-five percent of women in the study had at least two unsuccessful embryo transfers.

There was no significant difference between the groups of live births or pregnancy outcomes examined. The live birth rate was 180 out of 690 in the treated group and 176 out of the 674 control group, with no significant difference in primary or secondary outcomes.

In two subgroups of particular interest – women in whom implantation had failed at least twice or women in whom implantation had failed once – there had been also no evidence of benefit, said the authors. They noted that "subgroup badyzes did not identify any population of women likely to benefit". However, treated women experienced pain (the median was 3.5 out of 10) and 14 had side effects such as dizziness, nausea, and excessive bleeding.

With respect to the ubiquity of the procedure in patients undergoing IVF, a recent survey found that 83% of fertility clinicians in the UK, Australia and New Zealand offer or recommend scrapes of the endometrium, which can cost about 500 dollars to patients.

In an accompanying editorial, Ben W. Mol, MD, of the Monash University in Victoria, Australia, and Kurt T. Barnhart, MD, of the University of Pennsylvania in Philadelphia, pointed out that the trial had not reached the main result, and had no "suggestion of advantage" in the secondary results.

The procedure reflects current standards of care and the population – including women undergoing IVF for the first time and women whose previous cycles have been treated in centers in several countries – could be generalized to populations suffering from infertility in the community. whole world, they wrote. "Therefore, the results of this test should be trusted."

These results contrast with a 2016 Cochrane review document suggesting that, overall, there was an increased likelihood of clinical pregnancy with an endometrial scratch. Lensen's group warned that most of the trials included in this review presented a high risk of bias. Mol and Barnhart also found that the quality of this evidence was "moderate", highlighting a multitude of limitations of the Cochran review's trials, notably not prospectively recorded, showing an unrealistic significant effect on samples of limited size, using suboptimal randomization techniques or having been stopped prematurely.

Overall, the success rate of IVF remains "modest" at between 25 and 30% per cycle, said Lensen and colleagues.

The theory behind endometrial scratching is that a small endometrial injury could facilitate the implantation of the embryo via inflammatory and immunological mechanisms, do they have? added. The results of previous tests are far from unanimous to indicate effectiveness, with a single larger test "with a robust design" showing a lack of benefits, while an badysis in subgroup suggested lower pregnancy rates with this procedure. The grouped results of Cochrane review suggest a benefit, particularly for women who have failed IVF.

Mol and Barnhart pointed out that the ongoing "well-conducted" trial reinforced the idea that all adjuvants to fertility treatments and IVF should be carefully evaluated before being offered to patients who "might be receptive to anything that could hypothetically increase their chances of having a baby."

Source References: New England Journal of MedicineJanuary 24, 2019; DOI: 10.1056 / NEJMoa1808737

Editorial: New England Journal of MedicineJanuary 24, 2019; DOI: 10.1056 / NEJMe1815042

Highlights of the study: Explanation of results

According to the authors of this study, this pragmatic randomized trial conducted in five countries improves the "generalizability" of findings, according to which endometrial scarring had no impact on live birth rates. The editorialists agreed, suggesting that it was "Time Stop Stop" scratching the endometrium in IVF.

"Despite constant advances in techniques and technology since the introduction of IVF more than 40 years ago, [endometrial scratching] The authors have succeeded in less than half of the cycles initiated, "the authors added, adding that there is currently no regulatory framework for taking such procedures into account (27 according to a recent Cochrane study). of a higher rate of live births ".

Yet, "this simple and inexpensive procedure has been widely adopted by infertility specialists and used by tens of thousands of women around the world, at a typical fee of US $ 200-500", emphasized Lensen and his colleagues.

They criticized the design flaws of the Cochrane review meta-badysis and noted that the first "correctly conducted" randomized trial evaluating this procedure showed a relative risk of 0.83 (95% CI, 0.59 to 1). , 19) for the first end of pregnancy. The only "comfort" offered by the current trial is that it "caused no harm" other than pain and bleeding, they said.

This study emphasizes that all adjuvants to IVF and fertility treatments in general should be carefully evaluated before being offered to infertile couples likely to be receptive to anything that could hypothetically increase their chances of getting better. To have a baby, according to editorialists.

"An unanswered public health issue is whether IVF clinics and doctors around the world should continue to offer unbadessed adjuvants, recognizing the likelihood that they will be ineffective when properly evaluated and that some might cause damage, "they wrote.

"Misleading information about the effectiveness of adjuvants is already the subject of litigation involving couples who have used IVF," they added, referring to a couple who became the first in the UK to pursue an IVF clinic for having sold "without any value or evidence." additional interventions. Fertility specialists should "do no harm and do not offer false hope or sell snake oil," they concluded.

2019-01-28T13: 30: 00-0500