Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
NCT ID: NCT02942849
Last Updated: 2020-02-05
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
1195 participants
OBSERVATIONAL
2016-09-30
2018-12-31
Brief Summary
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Detailed Description
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About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.
As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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r-hFSH
As per standard clinical practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age over 18 years (inclusive) at the time of the screening visit
* Signed informed patient consent
* Received only Bemfola® for ovarian stimulation
* Pituitary suppression with GnRH-antagonists
Exclusion Criteria
* Tumours of the hypothalamus or pituitary gland
* Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
* Gynaecological haemorrhages of unknown aetiology
* Ovarian, uterine or mammary carcinoma
18 Years
FEMALE
No
Sponsors
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Finox AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jan-Steffen Krüssel, MD
Role: PRINCIPAL_INVESTIGATOR
Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)
Locations
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Team Kinderwunsch Oldenburg
Oldenburg, Lower Saxony, Germany
Countries
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Other Identifiers
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FIN-BEM-2016-04
Identifier Type: -
Identifier Source: org_study_id
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