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

NCT ID: NCT01408615

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-20

Study Completion Date

2016-11-18

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Enrolled Participants

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

corifollitropin alfa

Intervention Type DRUG

100 or 150 microgram single subcutaneous injection

Interventions

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corifollitropin alfa

100 or 150 microgram single subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Elonva

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P08165

Identifier Type: -

Identifier Source: org_study_id

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