Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)

M J Pelinck,Q D Pieterse,N E Van Hoogenhuijze ,Wietske Hermes ,Martine Nijs ,Astrid E P Cantineau ,Kathrin Fleischer ,Gijs Teklenburg ,Jeroen Van Disseldorp ,Eduard Scheenjes ,Minouche Van Rumste ,Catharina A.h Janssen ,Frank Willem Jansen ,Jacques W.m Maas ,Eva R Groenewoud ,Marinus J.c Eijkemans ,Egbert A Brinkhuis ,Madelon Van Wely ,Marcel H Van Hooff ,M.f.g Verberg ,Alexander V Sluijmer ,Jolanda C Boxmeer ,Jenneke C Kasius ,Cornelis B Lambalk ,Jantien Visser ,Etelka Moll ,Jan Peter De Bruin ,Cornelia De Koning ,A Petra Manger ,Femke Mol ,Ben J Cohlen ,Helen L Torrance ,M L Bandell ,J.m.j Smeenk ,Maaike A F Traas ,Joop Laven ,J.e Den Hartog ,Lucy F Van Der Voet ,Frank J Broekmans ,A Preys-Bosman,R Van Oppenraaij

doi:10.1186/s12905-017-0378-y

Abstract

BackgroundSuccess rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called ‘scratching’, has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle.MethodMulticenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2nd fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2nd IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure.DiscussionMultiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle.Trial registrationNTR 5342, registered July 31st, 2015.Protocol versionVersion 4.10, January 4th, 2017.

Highlights

Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation
Multiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing In-vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles
The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle

Summary

Introduction

Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle. A Cochrane review by Nastri et al suggests that for women undergoing ART, an endometrial scratch in the month prior to COH improves the chance of achieving a clinical pregnancy and live birth in women with two or more previously failed embryo transfers, but the evidence is of moderate quality at best [17]. The study introduced here aims to determine if endometrial scratching in the cycle prior to COH in women with one previously failed full IVF/ICSI cycle increases the chance of live birth. The study contains an embedded study that aims to determine characteristics, such as RNA profiles, of the endometrial lining that are associated with implantation failure

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