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RECRUITING
NCT07340827
PHASE3

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

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 42 Years

Study Type

INTERVENTIONAL

Enrollment

333

Start Date

2026-02-05

Completion Date

2029-06-30

Last Updated

2026-03-18

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Follitropin alfa/lutropin alfa (MBJ-0011)

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.

DRUG

hMG

Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.

DRUG

Cetrorelix acetate

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.

DRUG

Coriogonadotropin alfa

Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.

DRUG

Progesterone gel

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.

Locations (10)

Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology

Chiba, Chiba, Japan

YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology

Maebashi, Gunma, Japan

Kamiya Ladies Clinic - Dept of Gynecology

Sapporo, Hokkaido, Japan

Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology

Kobe, Hyōgo, Japan

Sophia Ladies Clinic - Dept of Obstetrics/Gynecology

Sagamihara-shi, Kanagawa, Japan

Ladies Clinic Cosmos - Dept of Infertility Treatment

Kochi, Kochi, Japan

JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology

Nagano, Nagano, Japan

Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology

Higashiosaka-shi, Osaka, Japan

KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology

Saitama-shi, Saitama, Japan

University of Tokyo Hospital - Dept of Obstetrics

Bunkyō City, Tokyo-To, Japan