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

NCT01408615 | Completed

• 1 other identifier: P08165
• Study Type: observational
• Target: 472
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (4)

• Number of Oocytes Retrieved

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

• Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)

  During treatment and up to 30 days after cessation of treatment

• 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

Study Arms (1)

All Enrolled Participants

Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program.

Drug: corifollitropin alfa

Interventions

corifollitropin alfa DRUG

100 or 150 microgram single subcutaneous injection

Also known as: Elonva

All Enrolled Participants

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Infertility, Female

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: August 3, 2011
• Study Start: September 20, 2011
• Primary Completion: November 18, 2016
• Study Completion: November 18, 2016
• Last Updated: February 3, 2022

Record last verified: 2022-02