Cumulative live birth rates in egg donor IVF cycles with or without endometrial scratching: Is there a residual effect in subsequent embryo transfers? Follow-up results of a RCT in clinical practice.

INTRODUCTION: Endometrial scratching (ES) is a simple technique that has been claimed to improve pregnancy rates in patients undergoing assisted reproduction techniques. Our objective was to acknowledge the effects of ES in subsequent embryo transfers by assessing the cumulative live birth rates (LBR) in patients undergoing egg-donor in vitro fertilization (IVF). MATERIAL AND METHODS: We performed a follow-up analysis of the cumulative reproductive outcomes of the 352 patients included in the Endoscratch Trial (NCT03108157) during the twelve months following the randomization date. We compared the outcomes of patients who underwent an ES for the second and/or successive embryo transfers versus those who did not have an ES performed, in order to determine a possible carry over effect that could lead to different LBR in these groups. RESULTS: Our analysis reveals that both groups (with and without ES performed before the first embryo transfer) had similar cumulative LBR (69.9% vs 65.9% in group A and B respectively, RR: 1.20, 95% confidence interval (CI): 0.92 - 1.22, p = 0.42). When we analyzed the results comparing patients who had received at least an ES before any of the embryo transfers during that period, we did not find any differences in LBR either (68.0% in patients with at least an ES and 67.8% in patients without ES, RR 1.00, 95%CI 0.87 - 1.16, p = 0.96). CONCLUSION: According to our results, we cannot state that ES has a long term effect on endometrial receptivity of egg recipients as cumulative LBR do not differ from those of patients who do not receive it.

Is Endometrial Scratching Beneficial for Patients Undergoing a Donor-Egg Cycle with or without Previous Implantation Failures? Results of a Post-Hoc Analysis of an RCT.

Endometrial scratching (ES) has been proposed as a useful technique to improve outcomes in in vitro fertilization (IVF) cycles, particularly in patients with previous implantation failures. Our objective was to determine if patients undergoing egg-donor IVF cycles had better live birth rates after ES, according to their previous implantation failures. Secondary outcomes were pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, and multiple pregnancy rate. We analysed the results of 352 patients included in the Endoscratch Trial (NCT03108157). A total of 209 were patients with one or no previous implantation failures (105 with an ES done in the previous cycle, group A1, and 104 without ES, group B1), and 143 were patients with at least two previous failed implantations (71 patients with ES, group A2, and 72 without ES, group B2). We found an improvement in pregnancy rates (62.9% in group A1 vs. 55.8% in group B1 vs. 70.4% in group A2 vs. 76.4% in group B2, p = 0.028) in patients with at least two previous implantation failures, but this difference was not statistically different when we compared clinical pregnancy rates (59.1% vs. 51.0% vs. 64.8% vs. 68.1% in groups A1, B1, A2 and B2, respectively, p = 0.104) and live birth rates (52.4% vs. 43.3% vs. 57.8% vs. 55.6% in groups A1, B1, A2 and B2, respectively, p = 0.218). According to these results, we conclude that there is no evidence to recommend ES in egg-donor IVF cycles, regardless of the number of previous failed cycles.

Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol.

BACKGROUND: 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. METHODS: This 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. DISCUSSION: Several 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 REGISTRATION: Ethical 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.

Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157).

The potential benefit of endometrial scratching (ES) on embryo implantation is still a controversial subject. At present, the single retrospective study in egg donor IVF cycles concluded that ES has no beneficial effect. Our objective was to determine if there are differences in clinical pregnancy rates (CPR) in egg donor cycles when an ES is performed. This is a randomized controlled trial (RCT) in egg donor IVF patients conducted at ProcreaTec Fertility Center in Madrid. Three hundred fifty-two patients were included in total. One hundred sixty-one patients completed the protocol in group A and 172 patients in group B. Patients allocated to group A received an ES in the luteal phase of the cycle preceding the embryo transfer cycle. Group B patients did not receive any intervention. Primary outcome of this RCT was CPR. Secondary outcomes were implantation (IR), miscarriage (MR), ongoing pregnancy (OPR), multiple pregnancy (MulPR), and live birth rates (LBR). CPR was 104 of 161 (64.6%) in group A and 102 of 172 (59.3%) in group B (RR 1.09, 95% confidence interval (CI) (0.92-1.29); p = 0.378). OPR, MR, MulPR, and LBR were also comparable. No major complications were detected after ES and pregnancy complications were comparable. Our results show that there is no beneficial role of ES in egg donor IVF cycles, considering these patients as the ideal model as they share homogeneous embryo quality and endometrial preparation protocols. This trial was registered on April 5, 2017, as the ENDOSCRATCH trial (NCT03108157).