Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031250671 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Follitropin alfa/lutropin alfa | Experimental | Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio. |
|
| Arm 2: Human Menopausal Gonadotropin (hMG) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin alfa/lutropin alfa (MBJ-0011) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of oocytes retrieved | 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. | At approximately 36 to 38 hours after r-hCG administration (Day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of gonadotropin (IU) used | Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH. | At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days) |
| Number of Days of Gonadotropin Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Contact | +49 6151 72 5200 | service@emdgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology | Recruiting | Chiba | Chiba | 261-8501 | Japan |
Not provided
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
Not provided
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21.
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union.
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Not provided
Not provided
Not provided
Not provided
|
|
| hMG | Drug | Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation. |
|
| Cetrorelix acetate | 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. |
|
|
| Coriogonadotropin alfa | Drug | Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation. |
|
|
| Progesterone gel | 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. |
|
Total number of days of ovarian stimulation will be reported.
| 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 | During Ovarian stimulation (Day 5 to Day 18) |
| Serum Estradiol (E2) levels | At Visit 3 after ovarian stimulation from Day 5-18 |
| Proportion of 2 Pronuclei Embryos/Fertilized Oocytes | The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported. | At 18 (Plus or minus two hours) hours after insemination |
| Number of blastocysts frozen | After the transfer of 1 fresh blastocysts - spare ones will be frozen. | 5 days after insemination |
| Number of Participants With Clinical Pregnancy | 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). | 35-42 days after Visit 5 (Blastocyst transfer) |
| Number of Participants With Ongoing Pregnancy | Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat. | 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 | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy |
| Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS) | 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 | 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 | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy |
| Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy |
| Number of Participants Experiencing Local Reactions | Pain redness, swelling, bruising, and itching around the injection site will be assessed. | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy |
| YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology | Recruiting | Maebashi | Gunma | 371-0031 | Japan |
|
| Kamiya Ladies Clinic - Dept of Gynecology | Recruiting | Sapporo | Hokkaido | 060-0003 | Japan |
|
| Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology | Recruiting | Kobe | Hyōgo | 650-0021 | Japan |
|
| Sophia Ladies Clinic - Dept of Obstetrics/Gynecology | Recruiting | Sagamihara-shi | Kanagawa | 252-0233 | Japan |
|
| Ladies Clinic Cosmos - Dept of Infertility Treatment | Recruiting | Kochi | Kochi | 780-0072 | Japan |
|
| JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology | Recruiting | Nagano | Nagano | 388-8004 | Japan |
|
| Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology | Recruiting | Higashiosaka-shi | Osaka | 577-0012 | Japan |
|
| KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology | Recruiting | Saitama-shi | Saitama | 330-0855 | Japan |
|
| University of Tokyo Hospital - Dept of Obstetrics | Recruiting | Bunkyō City | Tokyo-To | 113-8655 | Japan |
|
| Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology | Recruiting | Chiyoda-ku | Tokyo-To | 100-0005 | Japan |
|
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C062876 | cetrorelix |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided