Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant human luteinizing hormone · 1 trial · 2 indications
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...
Recombinant human luteinizing hormone is being studied for use in infertility, specifically for ovulation induction in women with reduced ovarian reserve. It is an investigational therapy in clinical development and is not yet approved for this use.
Recombinant human luteinizing hormone is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for infertility treatment.
Recombinant human luteinizing hormone is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for infertility.
Recombinant human luteinizing hormone has one completed Phase 2 trial, NCT01110707, which enrolled 131 women with reduced ovarian reserve. The study was conducted in Spain and evaluated the drug combined with lutropin alpha for ovulation induction.
Recombinant human luteinizing hormone is not the same as lutropin alpha, though they are related. In the clinical trial NCT01110707, lutropin alpha was used as a parallel control to compare the efficacy and safety of combined treatment with recombinant human luteinizing hormone.