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 now · Phase 3

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT07340827

Run by

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

People needed

266

Starts

2026-02-04

Expected to finish

2028-07-05

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants who are premenopausal wishing to conceive
• Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
• Japanese Participants
• Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
• Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
• A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology
• Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening
• Other protocol defined criteria may apply

You may not qualify if…

• Participants with history of severe OHSS in any previous ovarian stimulation cycle
• Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
• Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
• Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
• Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
• other protocol defined exclusion criteria may apply

Where it is running

• Akita University Hospital - Dept of Obstetrics/Gynecology — Akita, Akita, Japan (enrolling)
• Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology — Chiba, Chiba, Japan (enrolling)
• YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology — Maebashi, Gunma, Japan (enrolling)
• Kamiya Ladies Clinic - Dept of Gynecology — Sapporo, Hokkaido, Japan (enrolling)
• Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology — Kobe, Hyōgo, Japan (enrolling)
• Sophia Ladies Clinic - Dept of Obstetrics/Gynecology — Sagamihara-shi, Kanagawa, Japan (enrolling)
• Ladies Clinic Cosmos - Dept of Infertility Treatment — Kochi, Kochi, Japan (enrolling)
• Nagano Municipal Hospital - Dept of Gynecology — Nagano, Nagano, Japan (enrolling)
• JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology — Nagano, Nagano, Japan (enrolling)
• Sora no Mori Clinic - Dept of Obstetrics/Gynecology — Shimajiri-gun, Okinawa, Japan (enrolling)
• Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology — Higashiosaka-shi, Osaka, Japan (enrolling)
• Haruki Ladies Clinic - Dept of Gynecology — Osaka, Osaka, Japan (enrolling)
• KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology — Saitama-shi, Saitama, Japan (enrolling)
• Omiya Ladies Clinic - Dept of Gynecology — Saitama-shi, Saitama, Japan (enrolling)
• Dokkyo Medical University Hospital - Dept of Reproduction Center — Shimotsuga-gun, Tochigi, Japan (enrolling)
• Tokushima University Hospital - Dept of Obstetrics/Gynecology — Tokushima, Tokushima, Japan (enrolling)
• Juntendo University Hospital - Dept of Obstetrics/ Gynecology — Bunkyō City, Tokyo-To, Japan (enrolling)
• University of Tokyo Hospital - Dept of Obstetrics — Bunkyō City, Tokyo-To, Japan (enrolling)
• Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology — Chiyoda-ku, Tokyo-To, Japan (enrolling)
• Toho University Omori Medical Center - Dept of Obstetrics/Gynecology — Ōta-ku, Tokyo-To, Japan (enrolling)
• Sugiyama Clinic Shinjuku - Dept of Reproductive Medical — Shinjuku-ku, Tokyo-To, Japan (enrolling)

Full record on ClinicalTrials.gov

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