Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02785822
Status:
TERMINATED
Last Update Posted:
2019-02-25
First Post:
2016-05-25
Brief Title:
Study to Compare hFSH-HP Fostipur and hMG-HPMeriofert in Patients With Polycystic Ovary Under a IVFICSI Cycle
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Randomized Single Blind Prospective Clinical Study to Compare hFSH-HP Fostipur and hMG-HPMeriofert in Patients With Polycystic Ovary Under a IVFICSI Cycle
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties in recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None