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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01408615

Enrollment

472

Registered

2011-08-03

Start date

2011-09-20

Completion date

2016-11-18

Last updated

2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

DRUGcorifollitropin alfa

100 or 150 microgram single subcutaneous injection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)	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 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026