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Brief Title: Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
Official Title: Randomized, Single Blind, Prospective Clinical Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
Study ID: NCT02785822
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Fundaci贸 Puigvert, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Name: Juan J Espinos, MD
Affiliation: Fundaci贸 Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: STUDY_CHAIR