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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)
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
266
Start Date
2026-02-04
Completion Date
2028-07-05
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
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.
hMG
Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
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.
Coriogonadotropin alfa
Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
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 (21)
Akita University Hospital - Dept of Obstetrics/Gynecology
Akita, Akita, Japan
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
Nagano Municipal Hospital - Dept of Gynecology
Nagano, Nagano, Japan
JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology
Nagano, Nagano, Japan
Sora no Mori Clinic - Dept of Obstetrics/Gynecology
Shimajiri-gun, Okinawa, Japan
Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology
Higashiosaka-shi, Osaka, Japan
Haruki Ladies Clinic - Dept of Gynecology
Osaka, Osaka, Japan
KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology
Saitama-shi, Saitama, Japan
Omiya Ladies Clinic - Dept of Gynecology
Saitama-shi, Saitama, Japan
Dokkyo Medical University Hospital - Dept of Reproduction Center
Shimotsuga-gun, Tochigi, Japan
Tokushima University Hospital - Dept of Obstetrics/Gynecology
Tokushima, Tokushima, Japan
Juntendo University Hospital - Dept of Obstetrics/ Gynecology
Bunkyō City, Tokyo-To, Japan
University of Tokyo Hospital - Dept of Obstetrics
Bunkyō City, Tokyo-To, Japan
Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology
Chiyoda-ku, Tokyo-To, Japan
Toho University Omori Medical Center - Dept of Obstetrics/Gynecology
Ōta-ku, Tokyo-To, Japan
Sugiyama Clinic Shinjuku - Dept of Reproductive Medical
Shinjuku-ku, Tokyo-To, Japan