A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)

• Status: Completed
• Trial end date: 2016-11-18
• Target enrollment: 0
• Participant gender: Female

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 with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted reproductive technology (ART) program.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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