Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial (REAdME)

What this Trial Is About

Researchers are studying how fertility-limiting pelvic diseases like adenomyosis, uterine fibroids, and deep infiltrating endometriosis affect the receptivity of the endometrium in women with infertility. They aim to compare endometrial characteristics in women with these conditions to those with minimal or mild endometriosis and to healthy women whose infertility is due only to male factors. This project addresses the unclear treatment options available for these conditions and explores their systemic impact on fertility. The study has two parts: laboratory and clinical. In the laboratory phase, scientists will analyze endometrial samples from women with these diseases and healthy controls using techniques like bulk RNA sequencing and single-nucleus RNA sequencing to identify gene expression differences. The clinical phase will review reproductive outcomes in women managed either surgically or conservatively for infertility linked to adenomyosis and uterine fibroids. Samples will be collected during the first three years from five groups of infertile women categorized by their specific condition. Participants will provide endometrial tissue samples collected by hysteroscopy during the secretory phase of their cycle. Researchers will observe the uterine cavity and may remove any interfering pathologies during this procedure. Outcomes measured include the loss of endometrial receptivity at 12 weeks and pregnancy rates over two years. The study is observational and non-randomized, with all care provided under medical supervision. The total participation period includes sample collection and follow-up assessments related to fertility outcomes.

Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial