Comparing follitropin alfa/lutropin alfa versus hMG for Japanese women with LH and FSH deficiency undergoing assisted reproductive treatment.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial enrolls premenopausal Japanese women with congenital or acquired LH and FSH deficiency who are planning assisted reproductive technology (ART). Participants receive controlled ovarian stimulation with either follitropin alfa/lutropin alfa (MBJ-0011) or hMG, with standard co-medications such as cetrorelix acetate, corio gonadotropin alfa, and progesterone gel used according to the protocol. Investigators will monitor ovarian response, pregnancy outcomes, and safety over about 5.5 months for nonpregnant participants or up to 13 months if pregnancy occurs. Key eligibility includes an antral follicle count of at least 5 per ovary, a partner semen analysis suitable for ART, and no clinically significant uterine abnormality.

Why it matters

Who can join: the full rules

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

Where it's running

• Akita University Hospital - Dept of Obstetrics/Gynecology
  Akita, Akita, Japan Recruiting
• Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
  Chiba, Chiba, Japan Recruiting
• YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
  Maebashi, Gunma, Japan Recruiting
• Kamiya Ladies Clinic - Dept of Gynecology
  Sapporo, Hokkaido, Japan Recruiting
• Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
  Kobe, Hyōgo, Japan Recruiting
• Sophia Ladies Clinic - Dept of Obstetrics/Gynecology
  Sagamihara-shi, Kanagawa, Japan Recruiting

Study contacts

• Study coordinator: Communication Center
• Email: service@emdgroup.com
• Phone: +49 6151 72 5200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-assisted embryo selection on day 5 in IVF for infertility

  This trial tests whether an AI-based embryo selection tool can help pick the best embryo for transfer on day 5 in IVF/ICSI to improve pregnancy chances for people with infertility.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT07844083

• Preserving sperm quality with aging through cryopreservation

  This study tests whether freezing and thawing sperm can help keep younger-like DNA and molecular traits in men as they age.

  Recruiting IVI Murcia · Murcia, Murcia · NCT07814235

• Unstimulated Egg Retrieval with CAPA-IVM and Euploid Embryo Transfer

  This study tests whether eggs can be collected without ovarian stimulation, matured in the lab, and used to create a single euploid embryo for transfer in infertility patients.

  Recruiting CARE Fertility Texas · Bedford, Texas · NCT07801105

• Ultra-Long GnRH-a Pretreatment Before Frozen Embryo Transfer for Deep Infiltrating Endometriosis

  In people under 40 with deep infiltrating endometriosis and infertility, the study tests whether two injections of a GnRH agonist before hormone support improve pregnancy outcomes in their first frozen-thawed embryo transfer.

  Recruiting Phase 4 Nanjing University · Nanjing, Jiangsu · NCT07696351

• Endometrial Waves and Pregnancy in FET Cycles with Hormone Therapy

  This study tests whether patterns of uterine contractions during hormone-prepared frozen embryo transfer affect pregnancy outcomes.

  Recruiting Mỹ Đức Hospital · Ho Chi Minh City · NCT07675213

• Environmental and lifestyle factors linked to ART success in infertility patients

  This study follows 5,000 infertile men and women to see how environmental exposures and lifestyle relate to the success of assisted reproductive technology.

  Recruiting The Third Xiangya Hospital of Central South University · Changsha, Hunan · NCT07641387

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.