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

Recruiting Phase 3 Interventional Study
Infertility (IVF Patients)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 42
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
659 (estimated)
Sponsor
Granata Bio Corporation · Industry
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About 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.

Trial Locations
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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 recommend…
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