Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol
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(2020) 20:333
STUDY PROTOCOL
Open Access
Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol Alexandra Izquierdo1* , Laura de la Fuente2, Katharina Spies1, Jennifer Rayward1, Lourdes López1, David Lora3 and Alberto Galindo4
Abstract 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. Keywords: Endometrial scratching, Endometrial injury, In vitro fertilization, Recurrent implantation failure, Egg donation, Hysteroscopy, Endometrial receptivity
Background Embryo implantation remains one of the main challenges in assisted reproduction. Relevant improvements have been accomplished in reproductive medicine: different protocols for controlled ovarian stimulation and * Correspondence: [email protected] 1 ProcreaTec Fertility Clinic, Madrid, Spain Full list of author information is available at the end of the article
endometrial preparation, embryo culture with time-lapse technologies, embryo pre-implantational genetic testing and endometrial genetic assessment for implantation potential. Despite the fact that these changes have led to increasing pregnancy rates in the last few years, the implantation process is still inefficient, as it remains around 30% of all embryos replaced [1], and it is not yet totally understood.
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