Status:
COMPLETED
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Lead Sponsor:
Organon and Co
Conditions:
Infertility, Female
Eligibility:
FEMALE
Brief Summary
This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination ...
Eligibility Criteria
Inclusion
- \- Women with an indication for COS prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who meet the criteria as mentioned in the current Korean ELONVA local label
Exclusion
- Hypersensitivity to the active substance or to any of the excipients
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Primary ovarian failure
- Ovarian cysts or enlarged ovaries
- A history of OHSS
- A previous COS cycle that resulted in more than 30 follicles ≥ 11 mm measured by ultrasound examination
- Basal antral follicle count \> 20
- Fibroid tumors of the uterus incompatible with pregnancy
- Malformations of the reproductive organs incompatible with pregnancy
- Pregnancy
- Polycystic ovarian syndrome
Key Trial Info
Start Date :
September 20 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2016
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT01408615
Start Date
September 20 2011
End Date
November 18 2016
Last Update
February 3 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.