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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408615
• Other study ID #: P08165
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

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