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RECRUITING Phase 3 ClinicalTrials.gov

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)

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany • ClinicalTrials.gov ID: NCT07340827

Registry updated: 2026-09-08
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Description

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.

Interventions

  • 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.
  • hMG (Drug)
    Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
  • 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.
  • Coriogonadotropin alfa (Drug)
    Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
  • 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.

Eligibility criteria

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

Conditions

Infertility

Locations

  • Akita University Hospital - Dept of Obstetrics/Gynecology — Akita, Akita, Japan
  • Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology — Chiba, Chiba, Japan
  • YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology — Maebashi, Gunma, Japan
  • Kamiya Ladies Clinic - Dept of Gynecology — Sapporo, Hokkaido, Japan
  • Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology — Kobe, Hyōgo, Japan
  • Sophia Ladies Clinic - Dept of Obstetrics/Gynecology — Sagamihara-shi, Kanagawa, Japan
  • Ladies Clinic Cosmos - Dept of Infertility Treatment — Kochi, Kochi, Japan
  • Nagano Municipal Hospital - Dept of Gynecology — Nagano, Nagano, Japan
  • JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology — Nagano, Nagano, Japan
  • Sora no Mori Clinic - Dept of Obstetrics/Gynecology — Shimajiri-gun, Okinawa, Japan
  • Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology — Higashiosaka-shi, Osaka, Japan
  • Haruki Ladies Clinic - Dept of Gynecology — Osaka, Osaka, Japan
  • KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology — Saitama-shi, Saitama, Japan
  • Omiya Ladies Clinic - Dept of Gynecology — Saitama-shi, Saitama, Japan
  • Dokkyo Medical University Hospital - Dept of Reproduction Center — Shimotsuga-gun, Tochigi, Japan
  • Tokushima University Hospital - Dept of Obstetrics/Gynecology — Tokushima, Tokushima, Japan
  • Juntendo University Hospital - Dept of Obstetrics/ Gynecology — Bunkyō City, Tokyo-To, Japan
  • University of Tokyo Hospital - Dept of Obstetrics — Bunkyō City, Tokyo-To, Japan
  • Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology — Chiyoda-ku, Tokyo-To, Japan
  • Toho University Omori Medical Center - Dept of Obstetrics/Gynecology — Ōta-ku, Tokyo-To, Japan
  • Sugiyama Clinic Shinjuku - Dept of Reproductive Medical — Shinjuku-ku, Tokyo-To, Japan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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