Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pergoveris · 1 trial · 1 indication
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
| Arm | Type | Description |
|---|---|---|
| Pergoveris® | EXPERIMENTAL | - |
| GONAL-f® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pergoveris® | DRUG | Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. |
| GONAL-f® | DRUG | GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. |
| Recombinant human chorionic gonadotrophin (r-hCG) | DRUG | On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously |
Inclusion Criteria: * Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol * Female subjects, less tha...
Pergoveris is used for infertility in women undergoing assisted reproductive technology. It is a small molecule being developed by Merck & Company, Inc. (MRK) and has completed a Phase 3 clinical trial for this indication.
Pergoveris is developed by Merck & Company, Inc., which trades under the ticker MRK. The company conducted a Phase 3 study to evaluate the efficacy and safety of Pergoveris in assisted reproductive technology.
Pergoveris is in Phase 3 clinical development. A Phase 3 study, NCT02047227, has been completed. The drug is investigational and not yet approved for use.
Pergoveris has one completed Phase 3 clinical trial, NCT02047227, titled 'Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)'. The trial enrolled 939 female participants aged 18 years and older in Germany.
Pergoveris is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial for infertility. Approval status has not been established.