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

N/ACompletedNCT02941341

Finox AG1,222 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,222

Conditions

Infertility

Interventions

r-hFSHDRUG

As per standard practice

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IVI Barcelona

Barcelona, Spain

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

Number of fertilised oocytes

Time frame: 1 day after ovum pick-up

Quality of oocytes

Time frame: At Day 4-5

Number and quality of transferred embryos

Time frame: Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval

Fertilization and implantation rate

Time frame: 5 to 6 weeks after oocyte retrieval

Incidence of serious adverse events, including moderate-to-severe OHSS

Time frame: From Day 1 of stimulation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.