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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)

RecruitingPhase 3Ages 18 Years - 42 YearsFemaleMerck Healthcare KGaA, Darmstadt, Germany, an aff…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Follitropin alfa/lutropin alfa (MBJ-0011)
  • hMG
  • Cetrorelix acetate
  • Coriogonadotropin alfa
  • Progesterone gel
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Where

21 sites
Akita University Hospital - Dept of Obstetrics/Gynecology
Akita, Japan
Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
Chiba, Japan
YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
Maebashi, Japan
Kamiya Ladies Clinic - Dept of Gynecology
Sapporo, Japan
Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
Kobe, Japan
Sophia Ladies Clinic - Dept of Obstetrics/Gynecology
Sagamihara-shi, Japan
Ladies Clinic Cosmos - Dept of Infertility Treatment
Kochi, Japan
Nagano Municipal Hospital - Dept of Gynecology
Nagano, Japan

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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