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r-hFSH · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Infertile woman wishing to conceive and justifying ovarian stimulation treatment with gonadotrophins for in vivo conception * Aged 20-40 years (inclusive) * Male partner with acceptable semen analysis for intra-uterine insemination, according to center's standard practice * Ha...
r-hFSH is an investigational drug being studied for the treatment of infertility. It is being developed by Merck KGaA and is currently in Phase 2 clinical development. The drug is intended for use in infertile women, as evaluated in a clinical trial.
r-hFSH is a recombinant human follicle-stimulating hormone. It works by stimulating the ovaries to produce mature eggs, which is essential for ovulation and fertility. This mechanism is the basis for its use in treating infertility.
r-hFSH is being developed by Merck KGaA, a pharmaceutical company. The company's stock is traded under the ticker symbol MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of r-hFSH for infertility.
r-hFSH is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of infertility, with one completed Phase 2 trial.
r-hFSH has been studied in one clinical trial, identified as NCT01735422. This was a Phase 2 study that evaluated the safety and efficacy of recombinant human luteinizing hormone compared with urinary human chorionic gonadotrophin to trigger ovulation in infertile women. The trial was completed and enrolled 67 participants.
r-hFSH is not the same as r-hLH. r-hFSH is recombinant human follicle-stimulating hormone, while r-hLH is recombinant human luteinizing hormone. The clinical trial NCT01735422 compared r-hLH with u-hCG, not with r-hFSH. These are distinct hormones with different roles in fertility treatment.