Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
r-FSH · 1 trial · 1 indication
Oocytes recovery rate (oocytes per \>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \>14 mm in diameter.
| Arm | Type | Description |
|---|---|---|
| r-FSH + r-hLH | EXPERIMENTAL | Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist. |
| r-FSH | ACTIVE_COMPARATOR | Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist. |
| Name | Type | Description |
|---|---|---|
| r-FSH | DRUG | r-FSH will be administered as specified in the arm description. |
| r-hLH | DRUG | r-hLH will be administered as specified in the arm description. |
| Analogous GnRH antagonist | DRUG | Analogous GnRH antagonist will be administered as specified in the arm description. |
| r-hCG | DRUG | r-hCG will be administered as specified in the arm description. |
| Progesterone | DRUG | Progesterone will be administered as specified in the arm description. |
Inclusion Criteria: * Participants who were at risk of poor response by at least one of the following criteria: a) \<3 follicles in last cycle, or less than or equal to (\</=) 2 metaphase II oocytes, or estradiol (E2) \<600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicl...
r-FSH is an investigational small molecule being developed for ovarian stimulation, a procedure used in fertility treatment to induce the ovaries to produce multiple eggs. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
r-FSH is being developed by Merck KGaA, a German multinational pharmaceutical company. Merck KGaA trades on the OTC market under the ticker MKGAF.
r-FSH is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.
r-FSH has one completed Phase 2 clinical trial registered as NCT01112358, titled "Lutropin Alfa in Women at Risk of Poor Response." The trial enrolled 58 female participants in Spain and studied ovarian stimulation with an active control.
The completed clinical trial for r-FSH is titled "Lutropin Alfa in Women at Risk of Poor Response," suggesting that r-FSH may be the same compound as lutropin alfa. However, the drug is primarily referred to as r-FSH in development.