Abstract
BackgroundThe effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.MethodsThis single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups.DiscussionSeveral studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable.Trial registrationEthical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov.
Highlights
The effects of endometrial scratching (ES) on embryo implantation have been studied for many years
This review showed that endometrial injury on the day of oocyte retrieval decreased live birth (RR 0.31, 95% CI 0.14 to 0.69) and clinical pregnancy (RR 0.36, 95% CI 0.18 to 0.71)
When comparing egg donation cycles to other in vitro fertilization (IVF) treatments, we find two main differences: the first one is that embryo quality is presumably optimal, since all embryos come from donor eggs, avoiding the confusion factor of embryo quality according to maternal issues and the second difference is that all patients receive hormone replacement therapy with a homogeneous preparation of the endometrium, avoiding different hormonal environments caused by diverse responses to controlled ovarian stimulation in IVF
Summary
The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. A Cochrane Review by Lensen et al which includes 9 randomized controlled trials (RCTs), tried to determine the effects of ES in intrauterine insemination (IUI) cycles or in spontaneous conception cycles [6], suggesting a potential benefit of this technique. Senocak et al [7] found a better clinical pregnancy rate (CPR) and ongoing pregnancy rate (OPR) when scratching was performed the cycle prior to the insemination (OR 2,29, 95%IC:1.14–5.05), but a previous meta-analysis by Vitagliano et al [8] found similar differences when it was performed during the stimulation cycle (OR 2,04, p < 0,001)
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