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

Infertility Clinical Trial

— BIRTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941341
• Other study ID #: FIN-BEM-2015-01
• Status: Completed
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: February 2020
• Source: Finox AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1222
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• r-hFSH
As per standard practice

Locations

Country	Name	City	State
Spain	IVI Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Finox AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of oocytes retrieved		34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
Secondary	Number of fertilised oocytes		1 day after ovum pick-up
Secondary	Quality of oocytes		At Day 4-5
Secondary	Number and quality of transferred embryos		Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval
Secondary	Fertilization and implantation rate		5 to 6 weeks after oocyte retrieval
Secondary	Incidence of serious adverse events, including moderate-to-severe OHSS		From Day 1 of stimulation