NCT07216742

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

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 659 (estimated)
• Sponsor: Granata Bio Corporation · Industry
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility (IVF Patients)

Interventions

Type	Name	Description
DRUG	hMG subcutaneous injection	daily subcutaneous injection
DRUG	Placebo	daily subcutaneous injection

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-10-15
• Last updated: 2026-03-19

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study