Human Menopausal Gonadotropin for Infertility

(GRACE Trial)

Recruiting at 14 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Granata Bio Corporation

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

659 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women aged 18-42 with a BMI of ≥18 and <38, regular menstrual cycles (21-35 days), normal uterine cavity and ovaries, negative for certain infections, and have valid reasons for IVF treatment. Women over 40 need a normal mammogram. If using donor sperm, the donor must be 18-40 years old.

Inclusion Criteria

BMI ≥18 and <38 kg/m² at the time of consent

Menstrual cycles between 21-35 days

My last breast screening was normal and done within the last 2 years.

Exclusion Criteria

Greater than one IVF cycle canceled due to inability to meet ovulation trigger criteria

History of recurrent implantation failure (RIF) as defined by the Lugano Consensus

Recurrent pregnancy loss (RPL) defined by two or more miscarriages

What Are the Treatments Tested in This Trial?

Interventions

• Human Menopausal Gonadotropin

Trial Overview

The study tests if hMG injections can improve the development of multiple follicles, pregnancy rates, and cumulative live births in women undergoing ART cycles compared to placebo. It's multicenter, randomized, double-blind meaning neither participants nor researchers know who gets what until after results are collected.

How Is the Trial Designed?

Group I: hMG Experimental Treatment 1 Intervention

Human Menopausal Gonadotropin, daily subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

Placebo, daily subcutaneous injection

Who Is Running the Clinical Trial?

Granata Bio Corporation

Lead Sponsor