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

Completed

• Conditions: Infertility

• Registration Number: NCT02941341
• Lead Sponsor: Finox AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Primary Completion: 2018-04
• Study Completion: 2019-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1222

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of oocytes retrieved	34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment

Secondary Outcome Measures

Name	Time	Method
Quality of oocytes	At Day 4-5
Number of fertilised oocytes	1 day after ovum pick-up
Number and quality of transferred embryos	Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval
Fertilization and implantation rate	5 to 6 weeks after oocyte retrieval
Incidence of serious adverse events, including moderate-to-severe OHSS	From Day 1 of stimulation

Trial Locations

Locations (1)

IVI Barcelona; 🇪🇸 Barcelona, Spain