In this study a new sign to evaluate the evolution of pregnancy is described: the trophoblastic thickness at the embryonic implantation site. A prospective, observational study of 592 normal pregnancies with no known risk factors was carried out from January 1998 to February 1999. Serial ultrasound scans were performed from week 5 to week 12 of pregnancy. Trophoblastic thickness was measured at the embryonic implantation site to determine the significance of a difference in gestational age in weeks and a trophoblastic thickness of >/=3 mm in predicting poor prognosis in pregnancy outcome. The sensitivity of this sign in the prediction of spontaneous abortion was 82%, the specificity was 93%, the positive predictive value was 63% and the negative predictive value was 97%.
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.
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