A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
This prospective study will collect safety information from more than 600 patients treated with Pergoveris®.
During the Post-Marketing Surveillance (PMS) period, data about the patient´s background, patient's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) will be collected for study purposes.
The post marketing surveillance is based on all cases treated with Pergoveris®.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)|
- Frequency and severity of all adverse events regardless of the causal relationship to Pergoveris® [ Time Frame: 30 month ] [ Designated as safety issue: Yes ]
- Clinical pregnancy [ Time Frame: 30 month ] [ Designated as safety issue: No ]
- Percentage of patients with more than one follicle greater than 17mm on day of human chorionic gonadotrophin (HCG) administration [ Time Frame: 30 month ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416987
|Korea, Republic of|
|Merck Serono Research Site|
|Seoul, Korea, Republic of|
|Study Director:||Medical Responsible||Merck Ltd.|