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Recruiting NCT07340827

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)

Phase III Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follitropin alfa/lutropin alfa (MBJ-0011), hMG, Cetrorelix acetate, Coriogonadotropin alfa.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 42 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Combination product 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.
  • Drug hMG
    Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
  • Drug 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.
  • Drug Coriogonadotropin alfa
    Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
  • Drug 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.

Primary outcome measures

  • Total number of oocytes retrieved [Time frame: At approximately 36 to 38 hours after r-hCG administration (Day 4)]
Secondary outcome measures (12)
  • Total dose of gonadotropin (IU) used [Time frame: At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)]
  • Number of Days of Gonadotropin Treatment [Time frame: 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 [Time frame: During Ovarian stimulation (Day 5 to Day 18)]
  • Serum Estradiol (E2) levels [Time frame: At Visit 3 after ovarian stimulation from Day 5-18]
  • Proportion of 2 Pronuclei Embryos/Fertilized Oocytes [Time frame: At 18 (Plus or minus two hours) hours after insemination]
  • Number of blastocysts frozen [Time frame: 5 days after insemination]
  • Number of Participants With Clinical Pregnancy [Time frame: 35-42 days after Visit 5 (Blastocyst transfer)]
  • Number of Participants With Ongoing Pregnancy [Time frame: 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 [Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy]
  • Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS) [Time frame: 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 [Time frame: 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 [Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 21 centers
  • 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
  • … and 13 more centers

Identifiers

NCT: NCT07340827 · MS132705_0007 · jRCT2031250671

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗