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.
Granata Bio Corporation
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
- Age range
- 18–42 years
- Sex
- Female
- Healthy volunteers
- No
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) d…
Interventions
- DrughMG subcutaneous injection
daily subcutaneous injection
- DrugPlacebo
daily subcutaneous injection
Locations (16)
- HRC FertilityEncino, California
- Illume FertilityNorwalk, Connecticut
- Reproductive Associates of Delaware CCRMNewark, Delaware
- IVF Florida Reproductive AssociatesMargate, Florida
- Center for Reproductive MedicineWinter Park, Florida
- Reproductive Biology Associates (RBA)Atlanta, Georgia