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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Combination product: Follitropin alfa/lutropin alfa (MBJ-0011); Drug: Cetrorelix acetate; Drug: Coriogonadotropin alfa; Drug: Progesterone gel; Drug: hMG

• Study Type: Interventional
• Enrollment (Estimated): 333
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Communication Center; Phone Number: +49 6151 72 5200; Email: service@emdgroup.com

Study Locations

• Japan
  • Chiba
    • Chiba, Chiba, Japan, 261-8501
      • Recruiting
      • Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
      • Contact: Email: kawaikiyotaka@wfc-mom.jp
      • Principal Investigator: Kiyotaka Kawai
  • Gunma
    • Maebashi, Gunma, Japan, 371-0031
      • Recruiting
      • YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
      • Contact: Email: yoshimasa0709yokota@gmail.com
      • Principal Investigator: Yoshimasa Yokota
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0003
      • Recruiting
      • Kamiya Ladies Clinic - Dept of Gynecology
      • Contact: Email: nanakoiwami@gmail.com
      • Principal Investigator: Nanako Iwami
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0021
      • Recruiting
      • Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
      • Contact: Email: kokeguchi@hanabusaclinic.com
      • Principal Investigator: Shoji Kokeguchi
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0233
      • Recruiting
      • Sophia Ladies Clinic - Dept of Obstetrics/Gynecology
      • Contact: Email: hase009@sophia-lc.jp
      • Principal Investigator: Tomoya Hasegawa
  • Kochi
    • Kochi, Kochi, Japan, 780-0072
      • Recruiting
      • Ladies Clinic Cosmos - Dept of Infertility Treatment
      • Contact: Email: ch.kuwahara@lccosmos.jp
      • Principal Investigator: Akira Kuwahara
  • Nagano
    • Nagano, Nagano, Japan, 388-8004
      • Recruiting
      • JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology
      • Contact: Email: ryohei-n@yg8.so-net.ne.jp
      • Principal Investigator: Ryohei Nishimura
  • Osaka
    • Higashiosaka-shi, Osaka, Japan, 577-0012
      • Recruiting
      • Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology
      • Contact: Email: chiken2026@yahoo.co.jp
      • Principal Investigator: Aisaku Fukuda
  • Saitama
    • Saitama-shi, Saitama, Japan, 330-0855
      • Recruiting
      • KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology
      • Principal Investigator: Yuji Kashiwazaki
      • Contact: Email: yujiy1012@yahoo.co.jp
  • Tokyo-To
    • Bunkyō City, Tokyo-To, Japan, 113-8655
      • Recruiting
      • University of Tokyo Hospital - Dept of Obstetrics
      • Contact: Email: haradamtky@gmail.com
      • Principal Investigator: Miyuki Harada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Follitropin alfa/lutropin alfa; 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); 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.; Other Names: r-hFSH/r-hLH; MBJ-0011; Drug: Cetrorelix acetate; 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.; Other Names: GnRH; antagonist; Drug: Coriogonadotropin alfa; Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.; Other Names: r-hCG; Drug: Progesterone gel; 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.
Active Comparator: Arm 2: Human Menopausal Gonadotropin (hMG)	Drug: Cetrorelix acetate; 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.; Other Names: GnRH; antagonist; Drug: Coriogonadotropin alfa; Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.; Other Names: r-hCG; Drug: Progesterone gel; 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.; Drug: hMG; Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of gonadotropin (IU) used	Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH.	At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)
Number of Days of Gonadotropin Treatment	Total number of days of ovarian stimulation will be reported.	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	The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported.	At 18 (Plus or minus two hours) hours after insemination
Number of blastocysts frozen	After the transfer of 1 fresh blastocysts - spare ones will be frozen.	5 days after insemination
Number of Participants With Clinical Pregnancy	A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or with or without heartbeat (fetal sac).	35-42 days after Visit 5 (Blastocyst transfer)
Number of Participants With Ongoing Pregnancy	Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat.	up to 80 days after blastocyst transfer (pregnancy week 11 to 12)
Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events		5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)		5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome		5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome		5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs		5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants Experiencing Local Reactions	Pain redness, swelling, bruising, and itching around the injection site will be assessed.	5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

Collaborators and Investigators

• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Gonadotropins, infertility, prefilled pen
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone; cetrorelix
• Other Study ID Numbers: MS132705_0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No