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

Finox

Status: Completed

Conditions: Infertility

Treatments: Drug: r-hFSH

Study type: Observational

Funder types: Industry

Identifiers

NCT02942849

FIN-BEM-2016-04

Details and patient eligibility

About

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

Full description

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. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.

Enrollment: 1,195 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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