A Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of a Human Menopausal Gonadotropin in the Development of Multiple Follicles, Pregnancy, and Cumulative Live Birth as Part of an Assisted Reproductive Technology (ART) Cycle.
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.
• 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) definition, single women or same-sex couples) with the intention to achieve pregnancy within 12 months of the first stimulation cycle.
• Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a normal uterine cavity (i.e. no müllerian duct anomaly, uterine fibroids, endometrial polyps, intrauterine adhesions, adenomyosis) at screening or within 1 year prior to screening.
• Normal cervical cytology/high risk human papillomavirus (HPV) testing per American College of Obstetrician/Obstetrician Gynecologist (OB/GYN) (ACOG) guidelines.
• Negative serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody tests at screening.
• Absence of hydrosalpinx confirmed by hysterosalpingogram (HSG), sonohysterogram, laparoscopy, or other appropriate imaging within the past 12 months.
• Willing to undergo up to two ovarian stimulation cycles prior to frozen embryo transfer.
• Willing to self-administer study medications.
• Willing to have trophectoderm biopsy of all blastocyst stage embryos.
• Willing to accept transfer of one euploid embryo.
• Willing to vitrify and warm embryo(s) with intention to have a Frozen Embryo Transfer (FET).
• Willing and able to comply with the protocol and schedule of events for the duration of the study as well as providing delivery data and neonatal health data.