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

Finox

Status: Completed

Conditions: Infertility

Treatments: Drug: r-hFSH

Study type: Observational

Funder types: Industry

Identifiers

NCT02941341

FIN-BEM-2015-01

Details and patient eligibility

About

Non-comparative, observational, ambispective post-authorisation study (EPA-SP).

Enrollment: 1,222 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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