The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus
Barcelona, Spain
Number of Patients Producing Anti-FSH Antibodies.
The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.
Time frame: 4 months.
Number of Oocytes Retrieved
the number of oocytes retrieved in the first cycle and in the second cycle are compared.
Time frame: after 2 weeks of treatment
Total Dose of FSH Units Used.
Time frame: after 2 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.