Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00725491 | A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703) | PHASE3 | COMPLETED | 259 | — | — | May 1, 2007 | Dec 1, 2008 | Feb 3, 2022 | - | — |
| NCT00988260 | Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED) | PHASE2 | COMPLETED | 266 | — | — | Feb 3, 2003 | Apr 12, 2004 | Aug 15, 2024 | - | — |
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ganirelix |
| 2 | ACTIVE_COMPARATOR | triptorelin |
| Ganirelix 0.125 mg | EXPERIMENTAL | - |
| Ganirelix 0.25 mg | EXPERIMENTAL | - |
| Ganirelix 0.5 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ganirelix | DRUG | On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration. |
| triptorelin | DRUG | a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 \<= 50 pg/ml (\<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG. |
Inclusion Criteria: * females of infertile couples for whom COS and IVF or ICSI is indicated * body mass index between 18 and 29 kg/m2 * willing and able to give written informed consent. Exclusion Criteria: * More than three previous COS cycles for assisted reproduction since last established on...