Actively Recruiting

Phase 3
Age: 18Years - 42Years
FEMALE
NCT07216742

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

Led by Granata Bio Corporation · Updated on 2026-04-27

659

Participants Needed

16

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pre-menopausal women aged 18-42 years old at the time of consent.
  • BMI 18 and <38 kg/m8 at the time of consent.
  • Menstrual cycles between 21-35 days.
  • Normal mammogram or breast ultrasound if older than 40 or recommended by physician, within 2 years of screening.
  • Anti-M�fcllerian hormone (AMH) >1.2 ng/ml within 6 months of screening.
  • If using donor sperm, donor must be 18-40 years old and meet regulatory standards.
  • Transvaginal ultrasound showing both ovaries present, normal, and accessible for oocyte retrieval at screening or within 6 months.
  • Valid medical indication for IVF and embryo transfer with intention to become pregnant within 12 months.
  • Normal uterine cavity confirmed within 1 year prior to screening.
  • Normal cervical cytology and high-risk HPV testing per guidelines.
  • Negative tests for hepatitis B, hepatitis C, and HIV at screening.
  • No hydrosalpinx confirmed by imaging within the past 12 months.
  • Willing to undergo up to two ovarian stimulation cycles before frozen embryo transfer.
  • Willing to self-administer study medications.
  • Agree to have trophectoderm biopsy on all blastocyst embryos.
  • Willing to accept transfer of one euploid embryo.
  • Willing to vitrify and warm embryos for frozen embryo transfer.
  • Willing and able to follow study protocol and provide delivery and neonatal data.
Not Eligible

You will not qualify if you...

  • Persistent ovarian cysts larger than 20 mm, including endometrioma or dermoid cyst.
  • Liver impairment with liver tests over twice the normal limit or kidney impairment with creatinine clearance below 60 mL/min/1.73 m2.
  • Uncontrolled adrenal or thyroid problems or uncontrolled diabetes with HbA1C over 7% within 3 months.
  • More than one IVF cycle canceled due to insufficient follicle development.
  • History of recurrent implantation failure after multiple good-quality embryo transfers.
  • History of two or more miscarriages with the same partner.
  • Known anovulation.
  • Antral follicle count below 5 at screening.
  • Presence of dominant follicles larger than 11 mm with elevated estradiol before randomization.
  • Past or current estrogen-dependent cancer.
  • Untreated atypical endometrial hyperplasia.
  • Contraindications to oral contraceptives.
  • History of ovarian hyperstimulation syndrome.
  • Severe sperm abnormalities or prior failed fertilization in IVF.
  • Use of donor sperm back up, calcium ionophore, or surgically retrieved sperm.
  • Use of investigational drugs or medications interfering with reproductive function within specified timeframes.
  • Use of certain psychotropic medications contraindicated in pregnancy.
  • Chronic use of NSAIDs during cycle.
  • Recent treatment with fertility-related medications within 1 month.
  • Pregnancy, breastfeeding, or contraindication to gonadotropins.
  • Known blood clotting disorders without clearance.
  • Significant chromosomal abnormalities in patient or partner.
  • Current tobacco or marijuana use.
  • Recent alcohol or drug abuse.
  • Use of high-dose biotin supplements without washout.
  • Use of bioidentical hormones without washout.
  • History of chemotherapy or radiotherapy.
  • Undiagnosed uterine bleeding.
  • Tumors or malformations incompatible with pregnancy.
  • Active pelvic inflammatory disease.
  • Untreated fibroids or severe uterine pathology.
  • Severe endometriosis confirmed by imaging.
  • Participation in another study.
  • Couples with shared serious genetic conditions.
  • Planned use of gestational carrier.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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