NCT02785822

Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.

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.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	hMG-HP	Ovarian stimulation with hMG-HP (150 IU / day)
DRUG	hFSH-HP	Ovarian stimulation with hFSH-HP (150 IU / day)

Timeline

• Start date: 2017-02-23
• Primary completion: 2018-05-09
• Completion: 2018-05-09
• First posted: 2016-05-30
• Last updated: 2019-02-25

Locations

2 sites across 1 country: Spain