Actively 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)
Led by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Updated on 2026-03-18
333
Participants Needed
10
Research Sites
177 weeks
Total Duration
On this page
Sponsors
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women wishing to conceive
- Maximum of 1 previous ART stimulation without pregnancy
- Japanese women
- Diagnosed with LH and FSH deficiency, congenital or acquired
- Vaginal ultrasound showing both ovaries with no significant uterine abnormalities
- Normal antral follicle count of at least 5 follicles (2 to 10 mm) per ovary
- Male partner's semen analysis within 3 months suitable for ART
- Normal cervical ThinPrep cytologic test or Pap smear within 12 months
- Other protocol-defined criteria may apply
You will not qualify if you...
- History of severe ovarian hyperstimulation syndrome (OHSS) in previous cycles
- Polycystic ovarian syndrome according to Rotterdam criteria
- Contraindication or hypersensitivity to gonadotropins or their excipients
- Known or suspected gonadotropin- or estrogen-dependent malignancies
- Ovarian enlargement, cysts of unknown cause, or cysts larger than 25 mm before Day 1
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
Chiba, Chiba, Japan, 261-8501
Actively Recruiting
2
YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
Maebashi, Gunma, Japan, 371-0031
Actively Recruiting
3
Kamiya Ladies Clinic - Dept of Gynecology
Sapporo, Hokkaido, Japan, 060-0003
Actively Recruiting
4
Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
Kobe, Hyōgo, Japan, 650-0021
Actively Recruiting
5
Sophia Ladies Clinic - Dept of Obstetrics/Gynecology
Sagamihara-shi, Kanagawa, Japan, 252-0233
Actively Recruiting
6
Ladies Clinic Cosmos - Dept of Infertility Treatment
Kochi, Kochi, Japan, 780-0072
Actively Recruiting
7
JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology
Nagano, Nagano, Japan, 388-8004
Actively Recruiting
8
Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology
Higashiosaka-shi, Osaka, Japan, 577-0012
Actively Recruiting
9
KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology
Saitama-shi, Saitama, Japan, 330-0855
Actively Recruiting
10
University of Tokyo Hospital - Dept of Obstetrics
Bunkyō City, Tokyo-To, Japan, 113-8655
Actively Recruiting
Research Team
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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