A Randomized Controlled Trial Comparing Frozen Embryo Transfer Guided by Endometrial Receptivity Analysis Versus Standard Timing in Patients with Recurrent Implantation Failure

What this Trial Is About

Researchers are evaluating the clinical effectiveness of endometrial receptivity analysis (ERA) to guide the timing of frozen embryo transfer in women with recurrent implantation failure (RIF). RIF is defined as failure to achieve pregnancy after three embryo transfers and may be caused by a mismatch in timing between the embryo and the uterine lining. This multicenter, double-blind randomized controlled trial aims to compare ERA-guided embryo transfer timing to standard timing in improving pregnancy rates in women under 40 years old with RIF. Participants will first undergo an endometrial biopsy during a hormonal treatment cycle to perform ERA, which analyzes gene expression to identify the optimal implantation window. They will then be randomly assigned to either the intervention group, where frozen embryo transfer is timed according to ERA results, or the control group, where transfer occurs at standard timing after 5 days of progesterone use. Both groups receive similar hormonal preparation, and embryo transfer occurs within 1 to 3 months after biopsy. Follow-up continues until one week postpartum for those achieving pregnancy. During the study, participants will have blood tests, ultrasounds, and detailed recording of medical and reproductive history. Researchers will measure ongoing pregnancy rates at 10-12 weeks after transfer as the primary outcome, along with secondary outcomes including biochemical and clinical pregnancy rates, miscarriage rates, obstetric complications, and neonatal health indicators. Safety and efficacy will be monitored through regular assessments until delivery or pregnancy loss, with a total sample size of approximately 734 women planned for enrollment.

Comparing FET Guided by ERA Vs Standard Timing in Patients with Recurrent Implantation Failure