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

NCT07216742 | Recruiting Phase 3 FDA Drug

• 1 other identifier: GBHMG-301
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 16

Brief 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)

Keywords

Controlled ovarian stimulation; Gonadotropins; frozen embryo transfer; cumulative live birth rate; hMG

Outcome Measures

Primary Outcomes (1)

• cumulative live birth rate

  cumulative live birth rate following vitrified-thawed, single-euploid blastocyst transfer(s)

  12 months

Secondary Outcomes (26)

• Positive pregnancy (serum β-human chorionic gonadotropin [hCG])

  10 +/-2 days after Embryo transfer

• Clinical pregnancy (intrauterine gestational sac with fetal heartbeat)

  5 weeks ± 6 days post-embryo transfer

• Ongoing pregnancy (intrauterine pregnancy with fetal heartbeat)

  10 weeks ± 6 days post-embryo transfer (ET)

• Live birth rate

  9 months after ET

• Number of oocytes retrieved per stimulation cycle

  12-22 days after controlled ovarian stimulation start

Other Outcomes (14)

• Incidence, severity, timing, and duration of treatment-emergent adverse events (TEAEs), including action taken and outcome

  up to 10 weeks post embryo transfer

• Injection sites reactions (e.g., pain, erythema, swelling)

  20 days after Controlled ovarian stimulation start

• Incidence of early and late ovarian hyperstimulation syndrome (OHSS)

  up to 10 weeks post Embryo transfer

Study Arms (2)

hMG

EXPERIMENTAL

Human Menopausal Gonadotropin, daily subcutaneous injection

Drug: hMG subcutaneous injection

Placebo

PLACEBO COMPARATOR

Placebo, daily subcutaneous injection

Drug: Placebo

Interventions

hMG subcutaneous injection DRUG

daily subcutaneous injection

hMG

Placebo DRUG

daily subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a normal uterine cavity (i.e. no müllerian duct anomaly, uterine fibroids, endometrial polyps, intrauterine adhesions, adenomyosis) at screening or within 1 year prior to screening.
• Normal cervical cytology/high risk human papillomavirus (HPV) testing per American College of Obstetrician/Obstetrician Gynecologist (OB/GYN) (ACOG) guidelines.
• Negative serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody tests at screening.
• Absence of hydrosalpinx confirmed by hysterosalpingogram (HSG), sonohysterogram, laparoscopy, or other appropriate imaging within the past 12 months.
• Willing to undergo up to two ovarian stimulation cycles prior to frozen embryo transfer.
• Willing to self-administer study medications.
• Willing to have trophectoderm biopsy of all blastocyst stage embryos.

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.
• One or more dominant follicles (≥11 mm) observed on TVUS prior to randomization on stimulation day 1 with evidence of functional activity defined as serum Estradiol level \>100 pg/ml.
• Past or current history of an estrogen dependent malignancy
• Untreated atypical endometrial hyperplasia
• Any contraindication to the use of oral contraceptives
• History of OHSS.
• Morphological sperm evidence of globozoospermia or prior failed oocyte fertilization in previous IVF cycle.
• The use of donor sperm back up or rescue for fertilization of oocytes.

Sponsors & Collaborators

• Granata Bio Corporation: lead

Study Sites (16)

HRC Fertility

Encino, California, 91436, United States

RECRUITING

Illume Fertility

Norwalk, Connecticut, 06851, United States

RECRUITING

Reproductive Associates of Delaware CCRM

Newark, Delaware, 19713, United States

NOT YET RECRUITING

IVF Florida Reproductive Associates

Margate, Florida, 33036, United States

RECRUITING

Center for Reproductive Medicine

Winter Park, Florida, 32789, United States

RECRUITING

Reproductive Biology Associates (RBA)

Atlanta, Georgia, 30342, United States

RECRUITING

Fertility Institute of Hawaii

Honolulu, Hawaii, 96814, United States

RECRUITING

Fertility Centers of Illinois

Chicago, Illinois, 60610, United States

RECRUITING

Shady Grove Fertility - Rockville

Rockville, Maryland, 20850, United States

RECRUITING

Boston IVF

Waltham, Massachusetts, 02451, United States

RECRUITING

Reach Fertility

Charlotte, North Carolina, 28207, United States

RECRUITING

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

RECRUITING

Pinnacle Fertility - Oregon

Portland, Oregon, 97205, United States

RECRUITING

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010, United States

RECRUITING

CARE Fertility

Bedford, Texas, 76022, United States

RECRUITING

Shady Grove Houston

Webster, Texas, 77598, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)