Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Launched by FINOX AG · Oct 21, 2016
Trial Information
Current as of May 24, 2025
Completed
Keywords
ClinConnect Summary
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. T...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female subject justifying an IVF/ICSI treatment
- • 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:
- • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
- • 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
About Finox Ag
Finox AG is a biotechnology company dedicated to advancing the development of innovative therapeutics and diagnostics in the field of women's health. With a strong focus on addressing unmet medical needs, Finox AG employs cutting-edge research and development methodologies to create solutions that enhance patient outcomes. The company is committed to conducting high-quality clinical trials, ensuring compliance with regulatory standards, and fostering collaboration with healthcare professionals and research institutions to deliver safe and effective products to the market. Through its rigorous scientific approach and dedication to excellence, Finox AG aims to contribute significantly to the improvement of women's health globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oldenburg, Lower Saxony, Germany
Patients applied
Trial Officials
Jan-Steffen Krüssel, MD
Principal Investigator
Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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