Actively Recruiting
A Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Human Menopausal Gonadotropin in Infertility Assessing Multiple Follicle Development, Pregnancy, and Cumulative Live Birth in ART Cycles
Led by Granata Bio Corporation · Updated on 2026-04-27
659
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of human menopausal gonadotropin (hMG) in women diagnosed with infertility undergoing Assisted Reproductive Technology (ART) cycles. This phase 3, multicenter, randomized, placebo-controlled, double-blind study aims to assess the efficacy and safety of hMG in developing multiple follicles, achieving pregnancy, and increasing cumulative live birth rates over a 12-month period. Participants will receive either daily subcutaneous injections of hMG or a placebo. The study involves up to two ovarian stimulation cycles followed by frozen embryo transfer (FET). Researchers will monitor hormone levels, number and quality of oocytes, fertilization rates, blastocyst formation, and pregnancy milestones through various laboratory and imaging assessments. During the trial, participants will undergo regular evaluations including ultrasounds, blood tests for hormone measurements, and embryo biopsies. Researchers will track pregnancy progress through serum hCG tests and ultrasound confirmations of fetal heartbeat. The study follows participants for outcomes such as live birth rates up to nine months after embryo transfer. Participants must comply with study procedures and provide delivery and neonatal health data for the study duration.
CONDITIONS
Brief Title
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-menopausal women aged 18-42 years at consent
- Body mass index (BMI) between 18 and less than 38 kg/m² at consent
- Menstrual cycles lasting between 21 and 35 days
- Normal mammogram or breast ultrasound within 2 years if over 40, or as recommended if younger
- Anti-Müllerian hormone (AMH) level greater than 1.2 ng/ml within 6 months prior to screening
- Donor sperm must be from a donor aged 18-40 and meet regulatory requirements if used
- Transvaginal ultrasound confirming presence and accessibility of both ovaries without enlargement within 6 months prior to screening
- Valid medical indication for IVF treatment and embryo transfer with intention to achieve pregnancy within 12 months
- Normal uterine cavity confirmed by hysterosalpingography, hysteroscopy, or saline infusion sonography within 1 year prior to screening
- Normal cervical cytology and high-risk HPV testing per guidelines
- Negative tests for hepatitis B surface antigen, hepatitis C antibody, and HIV antibody at screening
- Absence of hydrosalpinx confirmed by appropriate imaging within past 12 months
- Willingness to undergo up to two ovarian stimulation cycles before frozen embryo transfer
- Willing to self-administer study medications
- Willing to have trophectoderm biopsy of all blastocyst stage embryos
- Willing to accept transfer of one euploid embryo
- Willing to vitrify and warm embryos intending frozen embryo transfer
- Ability and willingness to comply with study protocol and provide delivery and neonatal health data
You will not qualify if you...
- Persistent ovarian cystic lesions greater than or equal to 20 mm or clinically relevant for more than one cycle
- Hepatic impairment with liver function tests over twice the upper limit of normal
- Renal impairment with creatinine clearance below 60 mL/min/1.73 m²
- Uncontrolled adrenal or thyroid dysfunction or uncontrolled diabetes (HbA1C over 7% within 3 months)
- More than one IVF cycle canceled due to failure to meet ovulation trigger criteria
- History of recurrent implantation failure as defined by absence of implantation after multiple good-quality embryo transfers
- Recurrent pregnancy loss defined by two or more miscarriages documented clinically
- Known history of anovulation
- Antral follicle count less than 5 at screening
- Presence of dominant follicles with functional activity prior to randomization
- Past or current estrogen-dependent malignancy
- Untreated atypical endometrial hyperplasia
- Contraindications to oral contraceptives
- History of ovarian hyperstimulation syndrome (OHSS)
- Morphological sperm abnormalities or prior failed fertilization in previous IVF cycles
- Use of donor sperm back up or rescue for fertilization
- Use of certain sperm treatments such as calcium ionophore or methyl xanthines
- Need for surgically retrieved sperm
- Use of investigational drugs within 3 months prior to screening
- Use of medications interfering with study drug or reproductive function unless allowed
- Current use or dependence on contraindicated psychotropic medications unless benefits outweigh risks
- Required chronic use of NSAIDs during cycle
- Treatment with specific fertility drugs within 1 month prior to randomization
- Pregnancy, lactation, or contraindication to gonadotropins
- Known thrombophilia or history of blood clots unless cleared by a hematologist
- Clinically significant abnormal karyotype in patient or partner
- Current tobacco or marijuana use
- Recent abuse of alcohol or drugs within past 12 months
- Use of high-dose biotin supplements without proper washout
- Use of bioidentical hormones during stimulation or recent prior use without washout
- History of chemotherapy or radiotherapy
- Undiagnosed uterine bleeding
- Tumors or malformations incompatible with pregnancy
- Active pelvic inflammatory disease
- Untreated or severe uterine fibroids or pathology affecting implantation
- Severe endometriosis confirmed by imaging or surgery
- Participation in another study protocol
- Couples with shared autosomal recessive genetic conditions associated with serious offspring health outcomes
- Planned use of a gestational carrier
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 22 days per stimulation cycle, up to two cycles
Participants receive daily subcutaneous injections of either human menopausal gonadotropin or placebo to stimulate ovarian follicle development before undergoing controlled ovarian stimulation and embryo transfer procedures.
Multiple visits during each stimulation cycle for monitoring and assessments
Duration - Up to 12 months after embryo transfer
Participants are monitored after embryo transfer for pregnancy outcomes including biochemical pregnancy, clinical pregnancy, ongoing pregnancy, and live birth.
Several visits including approximately 3 key visits post-embryo transfer for pregnancy assessments
Trial Site Locations
Total: 16 locations
1
HRC Fertility
Encino, California, United States, 91436
Actively Recruiting
2
Illume Fertility
Norwalk, Connecticut, United States, 06851
Actively Recruiting
3
Reproductive Associates of Delaware CCRM
Newark, Delaware, United States, 19713
Not Yet Recruiting
4
IVF Florida Reproductive Associates
Margate, Florida, United States, 33036
Actively Recruiting
5
Center for Reproductive Medicine
Winter Park, Florida, United States, 32789
Actively Recruiting
6
Reproductive Biology Associates (RBA)
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Fertility Institute of Hawaii
Honolulu, Hawaii, United States, 96814
Actively Recruiting
8
Fertility Centers of Illinois
Chicago, Illinois, United States, 60610
Actively Recruiting
9
Shady Grove Fertility - Rockville
Rockville, Maryland, United States, 20850
Actively Recruiting
10
Boston IVF
Waltham, Massachusetts, United States, 02451
Actively Recruiting
11
Reach Fertility
Charlotte, North Carolina, United States, 28207
Actively Recruiting
12
Carolina Conceptions
Raleigh, North Carolina, United States, 27607
Actively Recruiting
13
Pinnacle Fertility - Oregon
Portland, Oregon, United States, 97205
Actively Recruiting
14
Main Line Fertility
Bryn Mawr, Pennsylvania, United States, 19010
Actively Recruiting
15
CARE Fertility
Bedford, Texas, United States, 76022
Actively Recruiting
16
Shady Grove Houston
Webster, Texas, United States, 77598
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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