Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Trial Parameters
Brief Summary
The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in women with a diagnosis of infertility.
Eligibility Criteria
Inclusion Criteria: * Pre-menopausal women aged 18-42 years old at the time of consent. * BMI ≥18 and \<38 kg/m² at the time of consent. * Menstrual cycles between 21-35 days. * Normal mammogram or breast ultrasound if patient is \>40 or if participant is younger as indicated by physician recommendation, within 2 years of screening. * Anti-Müllerian hormone (AMH) \>1.2 ng/ml within 6 months of screening. * If donor sperm is used, donor must be 18-40 years of age at the time of collection and compliant with 21 Code of Regulations (CFR) section 1271 Subpart C. * Transvaginal ultrasound (TVUS) documenting presence and adequate visualization of both ovaries without ovarian enlargement, normal adnexa, and both ovaries accessible for oocyte retrieval at screening or within 6 months of screening. * Valid medical indication for in vitro fertilization (IVF) treatment and subsequent embryo transfer (i.e. history of infertility according to current American Society of Reproductive Medicine (ASRM)