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A parallel-group treatment, 2-arm study to compare the efficacy andsafety of follitropin alfa and lutropin alfa fixed dose combinationversus hMG for inducing follicular development in Japaneseparticipants with LH and FSH deficiency undergoing ART (HINATA)

A study to compare the efficacy and safety of follitropin alfa/lutropinalfa versus hMG in Japanese participants with LH and FSH deficiencyundergoing ART (HINATA)

Ishii Kyoko

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan

MBJ_clinicaltrial_information@merckgroup.com

Contact for Clinical Trial Information

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan

+81-3-6756-0800

MBJ_clinicaltrial_information@merckgroup.com

Recruiting

Jan. 31, 2026

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

- Participants who are premenopausal wishing to conceive-Participants with maximum 1 previous stimulation for assistedreproductive technology (ART) without pregnancy
- Japanese Participants
- Participants are women with FSH and LH deficiency congenital oracquired
- Participants have a vaginal ultrasound scan showing both ovariesand no clinically significant uterine abnormality and a normal antralfollicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) indiameter per ovary
- A semen analysis of the male partner been performed within3 months prior to signature of informed consent and suitablefor ART
- Participants have a normal cervical ThinPrep cytologic test, (TCT) orPap smear within 12 monthsof Screening. If not available, a cervical smear will beperformed as part of screening
- Other protocol defined criteria may apply

- Participants with history of severe OHSS in any previous ovarianstimulation cycle
- Participants with Polycystic ovarian syndrome (PCOS) according toRotterdam 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-, ormammary carcinoma)
- Participants with ovarian enlargement or cyst of unknown etiology,orpresence of an ovarian cyst greater than > 25 mm before Day 1
- other protocol defined exclusion criteria may apply

Female

Infertility

[Arm 1]
Arm Title: Follitropin alfa/lutropin alfa
Type: Experimental
Description: Participants will receive fixedcombination product of recombinantFollitropin alfa (rechFSH)/lutropinalfa (rechLH) in a 2:1 ratio.
Arm 2]
Arm Title: Human MenopausalGonadotropin (hMG)
Type: Active Comparator
Description: NA

Outcome Measure: Total number of oocytes retrieved
TimeFrame: At approximately 36 to 38 hours afterr-hCG administration (Day 4)
Description: Mean number of oocytes retrievedwill be calculated. Oocyte retrievalwas a technique used in in-vitrofertilization in order to removeoocytes from the ovary of the female,enabling fertilization outside thebody.

Nov. 26, 2025

No

none