RecruitingInfertility (IVF Patients)

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

Eligible age

18–42 yrs

Accepts

Women

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: Granata Bio Corporation

You may qualify if…

✓ 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) documenting presence and adequate visualization of both ovaries without ovarian enlargement, normal adnexa, and both ovaries accessible for oocyte retrieval at screening or within 6 months of screening.
✓ Valid medical indication for in vitro fertilization (IVF) treatment and subsequent embryo transfer (i.e. history of infertility according to current American Society of Reproductive Medicine (ASRM) definition, single women or same-sex couples) with the intention to achieve pregnancy within 12 months of the first stimulation cycle.

You may not qualify if…

✕ 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.).
✕ History of recurrent implantation failure (RIF), defined according to the Lugano Consensus as the absence of implantation after transfer of ≥4 good-quality embryos in ≥3 embryo transfer (ET) cycles in women under the age of 40, using autologous oocytes.
✕ Recurrent pregnancy loss (RPL) is defined by two or more miscarriages; that is clinical pregnancies with the same partner and documented by ultrasonography or histopathological examination.
✕ Known history of anovulation.
✕ Antral Follicle Count (AFC) \<5 at screening.