Overview

Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.

Status:
Completed
Trial end date:
2019-04-01
Target enrollment:
0
Participant gender:
Female
Summary
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Finox AG
Criteria
Inclusion Criteria:

- Women aged ≥ 18 years

- Currently undergoing an IVF or ICSI cycle or are oocyte-donors

- Have completed controlled ovarian stimulation

- Have received at least 5 doses of Bemfola®

- Are pituitary suppressed with a GnRH antagonist

- Have undergone oocyte retrieval

- Have signed the Informed Consent Form

Exclusion Criteria:

- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the
excipients listed

- Presence of tumours of the hypothalamus or pituitary gland