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

Completed

• Conditions: Infertility, Female
• Interventions: Drug: corifollitropin alfa

• Registration Number: NCT01408615
• Lead Sponsor: Organon and Co

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Study Start: 2011-09-20
• Primary Completion: 2016-11-18
• Study Completion: 2016-11-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 472

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Enrolled Participants	corifollitropin alfa	Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program.

Primary Outcome Measures

Name	Time	Method
Number of Participants who report an serious adverse event (SAE)	During treatment and up to 30 days after cessation of treatment
Number of Participants who report an adverse event (AE)	During treatment and up to 30 days after cessation of treatment
Number of Oocytes Retrieved	At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)
Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)	During treatment and up to 30 days after cessation of treatment