Status
Recruiting
Phase
Phase 3
Enrollment
266
Locations
21
Results
Not posted
Publications
0
Study summary
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 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
Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
DRUG
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
Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
DRUG
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.
Timeline
First posted
Jan 14, 2026
Study start
Feb 4, 2026
Primary completion
Jul 5, 2028
Study completion
Jul 5, 2028
Results posted
Not reported
Registry updated
Jul 24, 2026
Outcomes
Total number of oocytes retrieved
Time frame · At approximately 36 to 38 hours after r-hCG administration (Day 4)
Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
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)
Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH.
Number of Days of Gonadotropin Treatment
Time frame · At Visit 3 after ovarian stimulation from Day 5-18
Total number of days of ovarian stimulation will be reported.
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
The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported.
Number of blastocysts frozen
Time frame · 5 days after insemination
After the transfer of 1 fresh blastocysts - spare ones will be frozen.
Number of Participants With Clinical Pregnancy
Time frame · 35-42 days after Visit 5 (Blastocyst transfer)
A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or with or without heartbeat (fetal sac).
Number of Participants With Ongoing Pregnancy
Time frame · up to 80 days after blastocyst transfer (pregnancy week 11 to 12)
Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat.
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
Eligibility
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
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Akita University Hospital - Dept of Obstetrics/Gynecology
Akita, Akita, Japan
Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
Chiba, Chiba, Japan
YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
Maebashi, Gunma, Japan
Kamiya Ladies Clinic - Dept of Gynecology
Sapporo, Hokkaido, Japan
Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
Kobe, Hyōgo, Japan
Sophia Ladies Clinic - Dept of Obstetrics/Gynecology
Sagamihara-shi, Kanagawa, Japan
Ladies Clinic Cosmos - Dept of Infertility Treatment
Kochi, Kochi, Japan
Nagano Municipal Hospital - Dept of Gynecology
Nagano, Nagano, Japan
JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology
Nagano, Nagano, Japan
Sora no Mori Clinic - Dept of Obstetrics/Gynecology
Shimajiri-gun, Okinawa, Japan
Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology
Higashiosaka-shi, Osaka, Japan
Haruki Ladies Clinic - Dept of Gynecology
Osaka, Osaka, Japan
KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology
Saitama-shi, Saitama, Japan
Omiya Ladies Clinic - Dept of Gynecology
Saitama-shi, Saitama, Japan
Dokkyo Medical University Hospital - Dept of Reproduction Center
Shimotsuga-gun, Tochigi, Japan
Tokushima University Hospital - Dept of Obstetrics/Gynecology
Tokushima, Tokushima, Japan
Juntendo University Hospital - Dept of Obstetrics/ Gynecology
Bunkyō City, Tokyo-To, Japan
University of Tokyo Hospital - Dept of Obstetrics
Bunkyō City, Tokyo-To, Japan
Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology
Chiyoda-ku, Tokyo-To, Japan
Toho University Omori Medical Center - Dept of Obstetrics/Gynecology
Ōta-ku, Tokyo-To, Japan
Sugiyama Clinic Shinjuku - Dept of Reproductive Medical
Shinjuku-ku, Tokyo-To, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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