- Title:
- A Randomized Trial of Endometrial Scratching before In Vitro Fertilization
- Journal:
- N Engl J Med 2019; 380:325-334
- Author(s):
- Sarah Lensen, Ph.D., Diana Osavlyuk, M.Sc., Sarah Armstrong, M.B., Ch.B., M.R.C.O.G., Caroline Stadelmann, M.D., Aurélie Hennes, M.Sc., Emma Napier, B.Sc., Jack Wilkinson, Ph.D., Lynn Sadler, M.P.H., Devashana Gupta, C.R.E.I., Annika Strandell, M.D., Ph.D., Christina Bergh, M.D., Ph.D., Kugajeevan Vigneswaran, M.R.C.O.G., Wan T. Teh, F.R.A.N.Z.C.O.G., Haitham Hamoda, M.D., F.R.C.O.G., Lisa Webber, M.R.C.O.G., Sarah A. Wakeman, M.B., Ch.B., Leigh Searle, F.R.A.N.Z.C.O.G., Priya Bhide, M.D., F.R.C.O.G., Simon McDowell, C.R.E.I., Karen Peeraer, Ph.D., Yacoub Khalaf, M.D., F.R.C.O.G., and Cynthia Farquhar, F.R.A.N.Z.C.O.G., M.P.H
- Author(s) affiliation:
- 1From the Department of Obstetrics and Gynaecology, University of Auckland (S.L., D.O., C.F.), and Women's Health (L. Sadler) and Fertility Plus (D.G., C.F.), Auckland District Health Board, Auckland, Fertility Associates, Christchurch (S.A.W.), and Fertility Associates, Wellington (L. Searle, S.M.) - all in New Zealand; Bath Fertility Centre, Bath (S.A., E.N.), the Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester (J.W.), and the Department of Obstetrics and Gynaecology, King's College Hospital (K.V., H.H.), University College Hospital (L.W.), Homerton Fertility Centre, Homerton University Hospital NHS Foundation Trust (P.B.), and Guy's Hospital (Y.K.), London - all in the United Kingdom; the Department of Obstetrics and Gynecology, Institute of Clinical Sciences, University of Gothenburg, Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden (C.S., A.S., C.B.); Leuven University Fertility Center, Department of Obstetrics and Gynecology, University Hospitals, Leuven, Belgium (A.H., K.P.); and Reproductive Services, Royal Women's Hospital, Melbourne, VIC, Australia (W.T.T.).
- Short description:
- The success rate of in vitro fertilization (IVF) remains modest; the probability of live birth is approximately 25 to 30% per initiated cycle.1-3 Endometrial scratching, which involves the obtaining of an endometrial-biopsy sample with a sampler such as the pipelle, has been proposed to increase the success rate of IVF. It has been postulated that the endometrial injury, or “scratch,” that results from the biopsy may facilitate embryo implantation by inflammatory and immunologic mechanisms. Pooled results from randomized trials have suggested benefit from this procedure, especially in women in whom implantation had failed previously. However, many trials have had methodologic limitations, including small size, and unclear methods of randomization and concealment of trial-group assignments; some have been published only as conference abstracts. One of the larger trials with a robust design showed a lack of benefit from endometrial scratching; a subgroup analysis suggested lower rates of pregnancy with this intervention than with no intervention among women in whom implantation had failed repeatedly. Despite conflicting evidence, a recent survey showed that 83% of fertility clinicians in the United Kingdom, Australia, and New Zealand offer or recommend endometrial scratching, which can cost patients as much as £400 (approximately $500 U.S.). We conducted the Pipelle for Pregnancy (PIP) trial to investigate whether endometrial scratching, delivered by an endometrial pipelle biopsy, increases the probability of live birth in women undergoing IVF.
- Link to the journal
Abstract taken from PubMed
- Background:
- Endometrial scratching (with the use of a pipelle biopsy) is a technique proposed to facilitate embryo implantation and increase the probability of pregnancy in women undergoing in vitro fertilization (IVF).
- Methods:
- We conducted a pragmatic, multicenter, open-label, randomized, controlled trial. Eligible women were undergoing IVF (fresh-embryo or frozen-embryo transfer), with no recent exposure to disruptive intrauterine instrumentation (e.g., hysteroscopy). Participants were randomly assigned in a 1:1 ratio to either endometrial scratching (by pipelle biopsy between day 3 of the cycle preceding the embryo-transfer cycle and day 3 of the embryo-transfer cycle) or no intervention. The primary outcome was live birth.
- Results:
- A total of 1364 women underwent randomization. The frequency of live birth was 180 of 690 women (26.1%) in the endometrial-scratch group and 176 of 674 women (26.1%) in the control group (adjusted odds ratio, 1.00; 95% confidence interval, 0.78 to 1.27). There were no significant between-group differences in the rates of ongoing pregnancy, clinical pregnancy, multiple pregnancy, ectopic pregnancy, or miscarriage. The median score for pain from endometrial scratching (on a scale of 0 to 10, with higher scores indicating worse pain) was 3.5 (interquartile range, 1.9 to 6.0).
- Conclusions:
- Endometrial scratching did not result in a higher rate of live birth than no intervention among women undergoing IVF. (Funded by the University of Auckland and others; PIP Australian New Zealand Clinical Trials Registry number, ACTRN12614000626662 .).
- Link to the paper on PubMed
- Comment in:
- Scratching the Endometrium in In Vitro Fertilization - Time to Stop. [N Engl J Med. 2019]