Evaluating Follitropin AlfaLutropin Alfa Combination Compared to Human Menopausal Gonadotropin for LH and FSH Deficiency in Japanese Women Undergoing Assisted Reproductive Technology

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combination of follitropin alfa and lutropin alfa in Japanese women with luteinizing hormone LH and follicle stimulating hormone FSH deficiency who are undergoing assisted reproductive technology ART. This Phase 3 study focuses on women who have had at most one previous ART stimulation without pregnancy and aims to compare this combination product with human menopausal gonadotropin hMG. Participants will receive either a fixed combination of recombinant follitropin alfa and lutropin alfa in a 21 ratio or hMG during ovarian stimulation. The follitropin alfalutropin alfa combination is administered subcutaneously once daily starting with 150 IU of follitropin alfa and 75 IU of lutropin alfa for up to 18 days. Additional medications such as cetrorelix acetate, corio gonadotropin alfa, and progesterone gel are used during ovarian stimulation, final follicular maturation, and luteal phase support. During the study, participants will be monitored through vaginal ultrasound scans, semen analysis, and cytologic tests. Researchers will measure the total number of oocytes retrieved, hormone levels, number of follicles, fertilization rates, blastocyst freezing, and pregnancy outcomes. Safety will be assessed by tracking adverse events, ovarian hyperstimulation syndrome occurrences, laboratory changes, and local reactions over approximately 5.5 months for nonpregnant participants and up to 13 months for those with confirmed pregnancy.

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)