Infertility
Conditions
Keywords
Bemfola, r-hFSH, ART, Oocytes, OHSS, Pregnancy
Brief summary
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
Interventions
DRUGr-hFSH
As per standard practice
Sponsors
Finox AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of oocytes retrieved | 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of fertilised oocytes | 1 day after ovum pick-up |
| Quality of oocytes | At Day 4-5 |
| 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 |
Countries
Spain
Outcome results
None listed