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

Organon

Status: Completed

Conditions: Infertility, Female

Treatments: Drug: corifollitropin alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT01408615

P08165

Details and patient eligibility

About

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.

Enrollment: 472 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

472 participants in 1 patient group

All Enrolled Participants

Description:

Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program.

Treatment:

Drug: corifollitropin alfa