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
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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COMPLETED
472 participants
OBSERVATIONAL
2011-09-20
2016-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
100 or 150 microgram single subcutaneous injection
Interventions
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corifollitropin alfa
100 or 150 microgram single subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Other Identifiers
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P08165
Identifier Type: -
Identifier Source: org_study_id
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