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NCT Number: NCT07340827

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)

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Akita University Hospital - Dept of Obstetrics/Gynecology, Akita, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: MBJ-0011, r-hFSH/r-hLH

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.

Other names: GnRH, antagonist

Coriogonadotropin alfa

Drug

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

Other names: r-hCG

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.

Primary outcomes

  1. Total number of oocytes retrieved

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

    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.

Secondary outcomes

  1. Total dose of gonadotropin (IU) used

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

    Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH.

  2. Number of Days of Gonadotropin Treatment

    Time frame: At Visit 3 after ovarian stimulation from Day 5-18

    Total number of days of ovarian stimulation will be reported.

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

    Time frame: During Ovarian stimulation (Day 5 to Day 18)

  4. Serum Estradiol (E2) levels

    Time frame: At Visit 3 after ovarian stimulation from Day 5-18

  5. Proportion of 2 Pronuclei Embryos/Fertilized Oocytes

    Time frame: At 18 (Plus or minus two hours) hours after insemination

    The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported.

  6. Number of blastocysts frozen

    Time frame: 5 days after insemination

    After the transfer of 1 fresh blastocysts - spare ones will be frozen.

  7. Number of Participants With Clinical Pregnancy

    Time frame: 35-42 days after Visit 5 (Blastocyst transfer)

    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).

  8. Number of Participants With Ongoing Pregnancy

    Time frame: up to 80 days after blastocyst transfer (pregnancy week 11 to 12)

    Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat.

  9. Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events

    Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

  10. Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

  11. Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome

    Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

  12. Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome

    Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

  13. Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs

    Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

  14. Number of Participants Experiencing Local Reactions

    Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy

    Pain redness, swelling, bruising, and itching around the injection site will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Communication Center

CONTACT

[email protected]

+49 6151 72 5200

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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