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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)

NCT07340827

RecruitingPhase 3

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

Conditions: Infertility

Interventions: Follitropin alfa/lutropin alfa (MBJ-0011), hMG, Cetrorelix acetate, Coriogonadotropin alfa, Progesterone gel

Countries: Japan

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 42 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (21)

Akita, Akita, Japan
Chiba, Chiba, Japan
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Sagamihara-shi, Kanagawa, Japan
Kochi, Kochi, Japan
Nagano, Nagano, Japan
Nagano, Nagano, Japan
Shimajiri-gun, Okinawa, Japan
Higashiosaka-shi, Osaka, Japan
Osaka, Osaka, Japan
Saitama-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Shimotsuga-gun, Tochigi, Japan
Tokushima, Tokushima, Japan
Bunkyō City, Tokyo-To, Japan
Bunkyō City, Tokyo-To, Japan
Chiyoda-ku, Tokyo-To, Japan
Ōta-ku, Tokyo-To, Japan
Shinjuku-ku, Tokyo-To, Japan