Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of ELONVA in Usual Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 472
- Primary Endpoint
- Number of Participants who report an serious adverse event (SAE)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
All Enrolled Participants
Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program.
Intervention: corifollitropin alfa (Drug)
Outcomes
Primary Outcomes
Number of Participants who report an serious adverse event (SAE)
Time Frame: During treatment and up to 30 days after cessation of treatment
Number of Participants who report an adverse event (AE)
Time Frame: During treatment and up to 30 days after cessation of treatment
Number of Oocytes Retrieved
Time Frame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)
Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: During treatment and up to 30 days after cessation of treatment
Secondary Outcomes
No secondary outcomes reported