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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01408615
Other study ID # P08165
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2011
Est. completion date November 18, 2016

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 472
Est. completion date November 18, 2016
Est. primary completion date November 18, 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
corifollitropin alfa
100 or 150 microgram single subcutaneous injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

Outcome

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