A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japane… (NCT07340827) | Clinical Trial Compass
RecruitingPhase 3
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)
Japan266 participantsStarted 2026-02-05
Plain-language 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.
Who can participate
Age range
18 Years – 42 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total number of oocytes retrieved
Timeframe: At approximately 36 to 38 hours after r-hCG administration (Day 4)
Trial details
NCT IDNCT07340827
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany