clinical trial · 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)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·phase3·recruiting·n = 333
InfertilityFollitropin alfa/lutropin alfa (MBJ-0011)hMGCetrorelix acetateCoriogonadotropin alfaProgesterone gel
brief 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.
started
Feb 5, 2026
primary completion
Oct 31, 2028
completion
Jun 30, 2029
last updated
Mar 18, 2026
official 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol