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)

NCT07340827 | Recruiting Phase 3

• 1 other identifier: MS132705_0007
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART). The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.

Conditions

Infertility

Keywords

Gonadotropins, infertility, prefilled pen

Outcome Measures

Primary Outcomes (1)

• Total number of oocytes retrieved

  Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

  At approximately 36 to 38 hours after r-hCG administration (Day 4)

Secondary Outcomes (14)

• Total dose of gonadotropin (IU) used

  At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)

• Number of Days of Gonadotropin Treatment

  At Visit 3 after ovarian stimulation from Day 5-18

• Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter

  During Ovarian stimulation (Day 5 to Day 18)

• Serum Estradiol (E2) levels

  At Visit 3 after ovarian stimulation from Day 5-18

• Proportion of 2 Pronuclei Embryos/Fertilized Oocytes

  At 18 (Plus or minus two hours) hours after insemination

Study Arms (2)

Arm 1: Follitropin alfa/lutropin alfa

EXPERIMENTAL

Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.

Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011); Drug: Cetrorelix acetate; Drug: Coriogonadotropin alfa; Drug: Progesterone gel

Arm 2: Human Menopausal Gonadotropin (hMG)

ACTIVE COMPARATOR

Drug: hMG; Drug: Cetrorelix acetate; Drug: Coriogonadotropin alfa; Drug: Progesterone gel

Interventions

Cetrorelix acetate DRUG

Participants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG.

Also known as: GnRH, antagonist

Arm 1: Follitropin alfa/lutropin alfa; Arm 2: Human Menopausal Gonadotropin (hMG)

Coriogonadotropin alfa DRUG

Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.

Also known as: r-hCG

Arm 1: Follitropin alfa/lutropin alfa; Arm 2: Human Menopausal Gonadotropin (hMG)

Progesterone gel DRUG

Participants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support.

Arm 1: Follitropin alfa/lutropin alfa; Arm 2: Human Menopausal Gonadotropin (hMG)

Follitropin alfa/lutropin alfa (MBJ-0011) COMBINATION_PRODUCT

Follitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days.

Also known as: MBJ-0011, r-hFSH/r-hLH

Arm 1: Follitropin alfa/lutropin alfa

hMG DRUG

Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.

Arm 2: Human Menopausal Gonadotropin (hMG)

Eligibility Criteria

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

You may qualify if:

• 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® 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: collaborator
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (10)

Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology

Chiba, Chiba, 261-8501, Japan

RECRUITING

YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology

Maebashi, Gunma, 371-0031, Japan

RECRUITING

Kamiya Ladies Clinic - Dept of Gynecology

Sapporo, Hokkaido, 060-0003, Japan

RECRUITING

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

Kobe, Hyōgo, 650-0021, Japan

RECRUITING

Sophia Ladies Clinic - Dept of Obstetrics/Gynecology

Sagamihara-shi, Kanagawa, 252-0233, Japan

RECRUITING

Ladies Clinic Cosmos - Dept of Infertility Treatment

Kochi, Kochi, 780-0072, Japan

RECRUITING

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

Nagano, Nagano, 388-8004, Japan

RECRUITING

Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology

Higashiosaka-shi, Osaka, 577-0012, Japan

RECRUITING

KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology

Saitama-shi, Saitama, 330-0855, Japan

RECRUITING

University of Tokyo Hospital - Dept of Obstetrics

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

RECRUITING

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Central Study Contacts

Communication Center

CONTACT

+49 6151 72 5200; service@emdgroup.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union.
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

JP (10)