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Also known as Recombinant human follicle stimulating hormone (r-hFSH), Gonal-f®
Recombinant human follicle stimulating 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 follicle-stimulating hormone is used in infertility treatment, specifically for controlled ovarian stimulation and ovulation induction in women with reduced ovarian reserve. It is being studied as part of a combined treatment regimen for these patients.
Recombinant human follicle-stimulating hormone targets F9, also known as coagulation factor IX. It belongs to the exogenous protein class. By binding to F9, it is thought to influence pathways relevant to ovarian function, though its exact role in infertility treatment is still under investigation.
Recombinant human follicle-stimulating hormone is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is responsible for its clinical development in infertility indications.
Recombinant human follicle-stimulating hormone is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 2 trial has been completed.
Recombinant human follicle-stimulating hormone has been studied in one completed Phase 2 trial, NCT01110707. This randomized, active-controlled study enrolled 131 women with reduced ovarian reserve in Spain to evaluate the efficacy and safety of a combined treatment including lutropin alfa and recombinant human luteinizing hormone during controlled ovarian stimulation.
Yes, recombinant human follicle-stimulating hormone is also known as r-hFSH, which is the common abbreviation for recombinant human follicle stimulating hormone. These names refer to the same drug candidate.