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
Study ID
NCT07340827
Phase
PHASE3
Status
Recruiting
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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jan 14, 2026
Start date
Feb 5, 2026
Status verified
May 2026
Primary completion
Jul 5, 2028
Completion
Jul 5, 2028

Study Design

Enrollment
266 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Arm 2: Human Menopausal Gonadotropin (hMG)

Primary Outcome Measure

Total number of oocytes retrieved [ Time Frame: At approximately 36 to 38 hours after r-hCG administration (Day 4) ]

Central Contacts

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