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This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FE 999049 6 µg | Experimental |
| |
| FE 999049 9 µg | Experimental |
| |
| FE 999049 12 µg | Experimental |
| |
| FOLLISTIM 150 IU | Active Comparator | follitropin beta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FE 999049 | Drug |
| ||
| follitropin beta |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | End of stimulation (max 16 days after investigational medicinal product (IMP) start) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of follicles during stimulation | Up to 16 days | |
| Size of follicles during stimulation | Up to 16 days | |
| Endocrine profile measured by circulating levels of hormones |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site (there may be other sites in this country) | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33272623 | Result | Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4. |
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| Drug |
|
|
| Up to 16 days |
| Total IMP dose administered measured from first until last dose (end of stimulation) | Up to 16 days |
| Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing | 5 days (from oocyte retrieval to embryo transfer) |
| Successful pregnancy rate | 5-6 weeks after transfer |
| Frequency of adverse events | From signing informed consent form until end of trial visit = 8-9 weeks |
| Intensity of adverse events | From signing informed consent form until end of trial visit = 8-9 weeks |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000608977 | FE 999049 |
| C571802 | follitropin beta |
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