DRKS00022943
Completed
Not Applicable
Prospective Observational Post-Authorisation Study on Fresh-transfer and Freeze-all treatments of ART patients undergoing controlled ovarian stimulation with Follitropin alfa (Bemfola®) - FREEZE-A
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GEDEON RICHTER PHARMA GmbH
- Enrollment
- 956
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible patients must meet the following criteria:
- •\- Adult female patient with an indication for IVF/ICSI treatment
- •\- Planned first ART stimulation cycle
- •\- Planned to receive Bemfola® as monotherapy for ovarian stimulation
- •\- Signed Informed Patient Consent form (ICF)
Exclusion Criteria
- •Eligible patients must not meet the following criteria:
- •\- History of previous poor response to gonadotropins outside ART
- •\- Planned Fertility Protection (due to malignancies etc.)
- •\- Ovarian Random Start and Duo Stimulations
- •\- Serum AMH\-Level \< 1,0 ng/ml
Outcomes
Primary Outcomes
Not specified
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