Study to Test the Safety and Effectiveness of Human Menopausal Gonadotropin Injections for Women with Infertility Undergoing Assisted Reproductive Technology to Improve Pregnancy and Live Birth Rates

What this Trial Is About

Researchers are evaluating the effects of human menopausal gonadotropin hMG in women diagnosed with infertility undergoing Assisted Reproductive Technology ART cycles. This phase 3, multicenter, randomized, placebo-controlled, double-blind study aims to assess the efficacy and safety of hMG in developing multiple follicles, achieving pregnancy, and increasing cumulative live birth rates over a 12-month period. Participants will receive either daily subcutaneous injections of hMG or a placebo. The study involves up to two ovarian stimulation cycles followed by frozen embryo transfer FET. Researchers will monitor hormone levels, number and quality of oocytes, fertilization rates, blastocyst formation, and pregnancy milestones through various laboratory and imaging assessments. During the trial, participants will undergo regular evaluations including ultrasounds, blood tests for hormone measurements, and embryo biopsies. Researchers will track pregnancy progress through serum hCG tests and ultrasound confirmations of fetal heartbeat. The study follows participants for outcomes such as live birth rates up to nine months after embryo transfer. Participants must comply with study procedures and provide delivery and neonatal health data for the study duration.

Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.