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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Page 1 of 3 (10 locations)

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