Skip to main content
OpenTrials
Completed

NCT Number: NCT01408615

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corifollitropin alfa

Drug

100 or 150 microgram single subcutaneous injection

Other names: Elonva

Primary outcomes

  1. Number of Oocytes Retrieved

    Time frame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)

  2. Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: During treatment and up to 30 days after cessation of treatment

  3. Number of Participants who report an serious adverse event (SAE)

    Time frame: During treatment and up to 30 days after cessation of treatment

  4. Number of Participants who report an adverse event (AE)

    Time frame: During treatment and up to 30 days after cessation of treatment

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2011
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.