Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04122729
Status:
UNKNOWN
Last Update Posted:
2019-10-10
First Post:
2019-10-09
Brief Title:
N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
Sponsor:
Angelini Farmacéutica
Organization:
Angelini Farmacéutica
Study Overview
Official Title:
Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation
It is a non-interventional observational cross-sectional and retrospective national and multicenter study in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months
It is a non-interventional observational cross-sectional and retrospective national and multicenter study in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months
Detailed Description:
The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used human FSH and recombinant FSH in patients undergoing two consecutive cycles of IVFICSI with controlled ovarian stimulation
All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation
In order to avoid any bias the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS ie half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH and conversely the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH In order to avoid potential modifications to the inclusion criteria the time elapsed between the two cycles should not exceed 6 months
All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation
In order to avoid any bias the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS ie half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH and conversely the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH In order to avoid potential modifications to the inclusion criteria the time elapsed between the two cycles should not exceed 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None