Prospective Observational Post-Authorisation Study on Fresh-transfer and Freeze-all treatments of ART patients undergoing controlled ovarian stimulation with Follitropin alfa (Bemfola®)
- Conditions
- ART - Assisted Reproductive Technology
- Registration Number
- DRKS00022943
- Lead Sponsor
- GEDEON RICHTER PHARMA GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 956
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of typical characteristics of previously planned (elective) and unplanned freeze-all procedures after stimulation with Bemfola®, with a specific focus on non-elective freeze-all procedures as a response to the risk of ovarian hyperstimulation syndrome (OHSS)
- Secondary Outcome Measures
Name Time Method Analysis of frequency, indications, burdens and results of the freeze-all procedure<br>Assessment of the medicinal endometrial preparation (priming) when transferring cryopreserved embryos<br>Obtaining data from the daily practice (real-world data) on further treatment parameters for fertilization, cryopreservation, embryo development, luteal phase support, as well as implantation and pregnancy rates<br>Description of the tolerability profile of Bemfola®, including the incidence of Ovarian Hyperstimulation Syndrome (OHSS) and other adverse drug reactions (ADRs)