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Also known as Recombinant human follicle-stimulating hormone (r-hFSH), Gonalef® (Follitropin alfa), Gonalef®, follitropin alfa, r-hFSH, SJ-0021
Recombinant human follicle-stimulating hormone · 2 trials · 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 | - |
| r-hLH (825 International Units [IU]) | EXPERIMENTAL | - |
| r-hLH (2750 IU) | EXPERIMENTAL | - |
| r-hLH (5500 IU) | EXPERIMENTAL | - |
| r-hLH (11000 IU) | EXPERIMENTAL | - |
| r-hLH (22000 IU) | EXPERIMENTAL | - |
| u-hCG (5000 IU) | 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. |
| r-hFSH | DRUG | Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day). |
| r-hLH | DRUG | Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L). |
| u-hCG | DRUG | Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L). |
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. It is being studied in women with reduced ovarian reserve, a group that often responds less well to standard fertility stimulation protocols.
Recombinant human follicle-stimulating hormone targets F9, also known as coagulation factor IX. It is an exogenous protein, meaning it is a protein produced outside the body and introduced as a therapeutic agent rather than a conventional small molecule drug.
Recombinant human follicle-stimulating hormone is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is the sponsor responsible for advancing this infertility asset through clinical development.
Recombinant human follicle-stimulating hormone is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The completed Phase 2 trial enrolled 131 participants and was active-controlled and randomized.
Recombinant human follicle-stimulating hormone has been studied in one completed Phase 2 trial, NCT01110707. This randomized, active-controlled study evaluated the efficacy and safety of combined treatment with lutropin alfa and recombinant human luteinizing hormone during controlled ovarian stimulation in women with reduced ovarian reserve.
Yes, recombinant human follicle-stimulating hormone is also known as r-hFSH. The abbreviation r-hFSH stands for recombinant human follicle-stimulating hormone, and both names refer to the same investigational infertility treatment being developed by Merck KGaA.