Infertility Clinical Trial
Official title:
Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression
This will be a prospective, non-comparative, multi-centre, multi-country, observational
post-authorization study in Germany and Austria. The study will evaluate the use of
follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI.
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.
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