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.
Persistent (for >1 cycle), clinically relevant (per PI discretion) ovarian cystic lesion (≥20 mm), including ovarian endometrioma or dermoid cyst.
Participants with hepatic impairment (liver function tests > 2x upper limit of normal). Participants with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2).
Uncontrolled adrenal, thyroid dysfunction or uncontrolled diabetes (HbA1C >7% within 3 months from screening).
Greater than one IVF cycle canceled due to inability to meet ovulation trigger criteria (i.e. at least 2-3 follicles reach ≥18 mm.).
Parallel
hMG subcutaneous injection
Drugdaily subcutaneous injection
Placebo
Drugdaily subcutaneous injection
cumulative live birth rate
cumulative live birth rate following vitrified-thawed, single-euploid blastocyst transfer(s)
Positive pregnancy (serum β-human chorionic gonadotropin [hCG])
Clinical pregnancy (intrauterine gestational sac with fetal heartbeat)
Ongoing pregnancy (intrauterine pregnancy with fetal heartbeat)
Live birth rate
Incidence, severity, timing, and duration of treatment-emergent adverse events (TEAEs), including action taken and outcome
Injection sites reactions (e.g., pain, erythema, swelling)
Incidence of early and late ovarian hyperstimulation syndrome (OHSS)
Development of treatment-emergent anti-drug antibodies
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