Comparing follitropin alfa/lutropin alfa versus hMG for Japanese women with LH and FSH deficiency undergoing assisted reproductive treatment.
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
This will test whether a combined follitropin alfa/lutropin alfa injection works as well as hMG for Japanese premenopausal women with LH and FSH deficiency who are undergoing assisted reproductive technology.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 333 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Industry-sponsored |
| Locations | 10 sites (Chiba, Chiba and 9 other locations) |
| Trial ID | NCT07340827 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Premenopausal Japanese women who wish to conceive, have congenital or acquired LH and FSH deficiency, an antral follicle count of ≥5 per ovary, and no more than one prior ART stimulation without pregnancy.
Not a fit: Women without LH/FSH deficiency, those with very low ovarian reserve (AFC <5), significant uterine abnormalities, or partners with sperm unsuitable for ART are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined follitropin alfa/lutropin alfa regimen could provide an effective, targeted stimulation option for women with LH/FSH deficiency undergoing ART.
How similar studies have performed: Recombinant combined FSH+LH therapies similar to follitropin alfa/lutropin alfa (for example, marketed FSH+LH combinations) have shown benefit in some patients with LH deficiency, so this approach builds on prior clinical experience.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chiba, Chiba and 9 other locations
- 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)
- Ladies Clinic Cosmos - Dept of Infertility Treatment — Kochi, Kochi, Japan (Recruiting)
- JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology — Nagano, Nagano, Japan (Recruiting)
- Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology — Higashiosaka-shi, Osaka, Japan (Recruiting)
- KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology — Saitama-shi, Saitama, Japan (Recruiting)
- University of Tokyo Hospital - Dept of Obstetrics — Bunkyō City, Tokyo-To, Japan (Recruiting)
Study contacts
- Study coordinator: Communication Center
- Email: service@emdgroup.com
- Phone: +49 6151 72 5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.