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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01110707 | A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve | PHASE2 | COMPLETED | 131 | — | — | Jan 10, 2005 | Nov 15, 2006 | Mar 27, 2018 | 1 | Spain |
Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.
| Arm | Type | Description |
|---|---|---|
| r-hFSH + r-hLH | EXPERIMENTAL | - |
| r-hFSH alone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Recombinant human follicle stimulating hormone (r-hFSH) | DRUG | Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]). |
| Recombinant human luteinizing hormone (r-hLH) | DRUG | Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. |
Inclusion Criteria: All subjects must meet the following inclusion criteria within the 6 months prior to starting the pituitary suppression unless otherwise specified: * Postmenopausal woman aged between 35 and 40 years that wishes to become pregnant * Subjects with basal serum level (beginning of...