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 and is studied in assisted reproductive technology. It is a small molecule developed by Merck KGaA. The clinical program recorded for Pergoveris covers infertility in adult women, with a Phase 3 study conducted in Germany.
Pergoveris is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 3 ESPART study evaluating Pergoveris in assisted reproductive technology for infertility.
Pergoveris is in Phase 3 development for infertility. Its recorded Phase 3 trial, ESPART, is completed, and no active trials are currently listed for the program. Pergoveris is investigational in this clinical development setting.
Pergoveris has been studied in the Phase 3 ESPART trial, NCT02047227, titled Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris in Assisted Reproductive Technology. The trial enrolled 939 female participants aged 18 years and older in Germany and is completed.
The ESPART trial of Pergoveris was a Phase 3 randomized study with an active control design and no blinding. It enrolled 939 female participants aged 18 years and older with infertility in Germany and did not include healthy volunteers. The study is completed.
Yes, Pergoveris and Pergoveris® refer to the same product from Merck KGaA. Pergoveris® is the registered name styling of Pergoveris, which is in Phase 3 development for infertility and was evaluated in the completed ESPART trial, NCT02047227.