Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Finox AG
• Collaborator: Finox Biotech Germany GmbH

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