Actively Recruiting

Phase 3
Age: 18Years - 42Years
FEMALE
ID07340827

A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART

Led by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Updated on 2026-03-18

333

Participants Needed

10

Research Sites

34 weeks

Total Duration

On this page

Sponsors

M

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Lead Sponsor

M

Merck KGaA, Darmstadt, Germany

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a fixed combination of recombinant follitropin alfa and lutropin alfa compared to human menopausal gonadotropin (hMG) in Japanese women with luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency undergoing assisted reproductive technology (ART). This Phase 3 study focuses on follicular development and aims to understand how these treatments perform in this patient group. The study duration is about 5.5 months for participants who do not become pregnant and up to 13 months for those with confirmed pregnancy in Part A. Participants will be randomly assigned to receive either the fixed combination of follitropin alfa and lutropin alfa in a 2:1 ratio or hMG. Both treatments are administered subcutaneously once daily for up to 18 days during ovarian stimulation. Additional medications include daily injections of cetrorelix acetate from Day 5 or 6 until the day of recombinant human chorionic gonadotropin (r-hCG), followed by a subcutaneous injection of corio gonadotropin alfa during final follicular maturation. After oocyte retrieval, participants will self-administer progesterone gel intravaginally daily to support the luteal phase. Throughout the study, participants will undergo various assessments including follicle counts via ultrasound, serum estradiol measurements, and embryo evaluations such as fertilization rates and blastocyst freezing. Safety monitoring will track adverse events, including ovarian hyperstimulation syndrome (OHSS), laboratory changes, and local reactions. The primary outcome is the total number of oocytes retrieved approximately 36 to 38 hours after r-hCG administration. Secondary outcomes include gonadotropin dosage, treatment duration, pregnancy rates, and safety events. Regular visits and monitoring will support adherence and collect data over the study period.

CONDITIONS

Brief Title

A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants who are premenopausal wishing to conceive
  • Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
  • Japanese Participants
  • Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
  • Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
  • A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology
  • Participants have a normal cervical ThinPrep�ae cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening
  • Other protocol defined criteria may apply
Not Eligible

You will not qualify if you...

  • Participants with history of severe OHSS in any previous ovarian stimulation cycle
  • Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
  • Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
  • Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
  • Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
  • other protocol defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Up to 18 days of ovarian stimulation plus luteal phase support starting at oocyte retrieval

Participants receive daily subcutaneous injections of either a fixed combination of Follitropin alfa and Lutropin alfa or Human Menopausal Gonadotropin (hMG) to stimulate ovarian follicular development. Additional medications including Cetrorelix acetate are administered daily from Day 5 or 6 of stimulation until the day of r-hCG, followed by Coriogonadotropin alfa for final follicular maturation and progesterone gel for luteal phase support.

Approximately 3 visits during ovarian stimulation plus visits for oocyte retrieval and luteal phase support

Follow-up

Duration - Up to 13 months after blastocyst transfer

Participants are monitored for pregnancy outcomes and potential adverse events including ovarian hyperstimulation syndrome for up to 13 months after blastocyst transfer.

Periodic visits over several months for pregnancy and safety monitoring

Trial Site Locations

Total: 10 locations

1

Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology

Chiba, Chiba, Japan, 261-8501

Actively Recruiting

2

YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology

Maebashi, Gunma, Japan, 371-0031

Actively Recruiting

3

Kamiya Ladies Clinic - Dept of Gynecology

Sapporo, Hokkaido, Japan, 060-0003

Actively Recruiting

4

Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology

Kobe, Hyōgo, Japan, 650-0021

Actively Recruiting

5

Sophia Ladies Clinic - Dept of Obstetrics/Gynecology

Sagamihara-shi, Kanagawa, Japan, 252-0233

Actively Recruiting

6

Ladies Clinic Cosmos - Dept of Infertility Treatment

Kochi, Kochi, Japan, 780-0072

Actively Recruiting

7

JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology

Nagano, Nagano, Japan, 388-8004

Actively Recruiting

8

Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology

Higashiosaka-shi, Osaka, Japan, 577-0012

Actively Recruiting

9

KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology

Saitama-shi, Saitama, Japan, 330-0855

Actively Recruiting

10

University of Tokyo Hospital - Dept of Obstetrics

Bunkyō City, Tokyo-To, Japan, 113-8655

Actively Recruiting

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Research Team

C

Communication Center

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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