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

Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of ELONVA in Usual Practice

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: corifollitropin alfa

• Study Type: Observational
• Enrollment (Actual): 472

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Enrolled Participants; Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program.	Drug: corifollitropin alfa; 100 or 150 microgram single subcutaneous injection; Other Names: Elonva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2011
• Primary Completion (Actual): November 18, 2016
• Study Completion (Actual): November 18, 2016

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: P08165