Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
Status:
Terminated
Trial end date:
2018-05-09
Target enrollment:
Participant gender:
Summary
Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is
associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in
isolation, its therapeutic management has special connotations sometimes favoring the low
response although the standard is the tendency to hyperresponsiveness.
Although there are studies comparing the combination of FSH and LH and FSH in controlled
hyperstimulation of these patients, there are no previous prospective randomized studies
comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).
Therefore the aim of this study is to prove that both drugs are comparable in the treatment
of these patients. The test substances are marketed in Spain (Fostipur and Meriofert,
respectively) with an indication for use in these patients. In this study both medicines will
be administered in a randomized way under the usual conditions in which it is used in routine
clinical practice to compare the quantity of mature oocytes respect to the total oocytes
obtained, as a primary outcome measure.
Phase:
Phase 4
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator:
Programa de Reproducción Asistida F. Puigvert - HSCSP