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