NCT02941341
Completed
Not Applicable
Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
Finox AG1 site in 1 country1,222 target enrollmentOctober 2016
ConditionsInfertility
Drugsr-hFSH
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Finox AG
- Enrollment
- 1222
- Locations
- 1
- Primary Endpoint
- Total number of oocytes retrieved
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Total number of oocytes retrieved
Time Frame: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
Secondary Outcomes
- 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)
Study Sites (1)
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