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)

Официальное название

A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART

Обзор

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.

Вмешательства

• Комбинированный продукт Follitropin alfa/lutropin alfa (MBJ-0011)
  Follitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days.
• Препарат hMG
  Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
• Препарат Cetrorelix acetate
  Participants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG.
• Препарат Coriogonadotropin alfa
  Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
• Препарат Progesterone gel
  Participants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support.

Первичные конечные точки

• Total number of oocytes retrieved [Срок оценки: At approximately 36 to 38 hours after r-hCG administration (Day 4)]

Вторичные конечные точки (12)

• Total dose of gonadotropin (IU) used [Срок оценки: At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)]
• Number of Days of Gonadotropin Treatment [Срок оценки: At Visit 3 after ovarian stimulation from Day 5-18]
• Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter [Срок оценки: During Ovarian stimulation (Day 5 to Day 18)]
• Serum Estradiol (E2) levels [Срок оценки: At Visit 3 after ovarian stimulation from Day 5-18]
• Proportion of 2 Pronuclei Embryos/Fertilized Oocytes [Срок оценки: At 18 (Plus or minus two hours) hours after insemination]
• Number of blastocysts frozen [Срок оценки: 5 days after insemination]
• Number of Participants With Clinical Pregnancy [Срок оценки: 35-42 days after Visit 5 (Blastocyst transfer)]
• Number of Participants With Ongoing Pregnancy [Срок оценки: up to 80 days after blastocyst transfer (pregnancy week 11 to 12)]
• Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events [Срок оценки: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy]
• Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS) [Срок оценки: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy]
• Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome [Срок оценки: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy]
• Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome [Срок оценки: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Япония · 21 центр

• Akita University Hospital - Dept of Obstetrics/Gynecology — Akita
• Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology — Chiba
• YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology — Maebashi
• Kamiya Ladies Clinic - Dept of Gynecology — Sapporo
• Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gyn — Kobe
• Sophia Ladies Clinic - Dept of Obstetrics/Gynecology — Sagamihara-shi
• Ladies Clinic Cosmos - Dept of Infertility Treatment — Kochi
• Nagano Municipal Hospital - Dept of Gynecology — Nagano
• … и ещё 13 центров

Идентификаторы

NCT: NCT07340827 · MS132705_0007 · jRCT2031250671

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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