Status:
RECRUITING
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)
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE3
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) deficienc...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
February 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT07340827
Start Date
February 5 2026
End Date
June 30 2029
Last Update
March 18 2026
Active Locations (10)
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1
Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
Chiba, Chiba, Japan, 261-8501
2
YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
Maebashi, Gunma, Japan, 371-0031
3
Kamiya Ladies Clinic - Dept of Gynecology
Sapporo, Hokkaido, Japan, 060-0003
4
Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
Kobe, Hyōgo, Japan, 650-0021