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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)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Aug 7, 2026, no change to tracked fieldsv6-v7
  2. Trial sites expanded: 11 → 21 locations Start date: Feb 5, 2026 to Feb 4, 2026v5 Show 1 more changeShow less
    • Start date: Feb 5, 2026 to Feb 4, 2026
  3. Enrollment reduced: 333 → 266 participants Primary completion moved earlier from Oct 31, 2028 to Jul 5, 2028 · Completion moved earlier from Jun 30, 2029 to Jul 5, 2028 · Study sites: 10 to 11v4 Show 3 more changesShow less
    • Primary completion moved earlier from Oct 31, 2028 to Jul 5, 2028
    • Completion moved earlier from Jun 30, 2029 to Jul 5, 2028
    • Study sites: 10 to 11
  4. Study sites: 8 to 10v3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 8 · Start date changed from estimate of Jan 31, 2026 to Feb 5, 2026v2 Show 2 more changesShow less
    • Study sites: 1 to 8
    • Start date changed from estimate of Jan 31, 2026 to Feb 5, 2026
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merck KGaA
43 trials monitored
See 4 trials at risk
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.
Trial Details
NCT Number NCT07340827
Lead Sponsor Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Infertility
Enrollment 266 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov