Clinical Trial

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)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 changes
notable Trial sites expanded: 11 -> 21 locations 2026-07-25
notable Enrollment reduced: 333 -> 266 participants 2026-06-12
notable Primary completion moved earlier: 2028-10-31 -> 2028-07-05 2026-06-12
minor Completion moved earlier: 2029-06-30 -> 2028-07-05 2026-06-12
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 2026-02-04
Primary Completion 2028-07-05 (estimated)
Study Completion 2028-07-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-10