N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS

• Conditions: Controlled Ovarian Stimulation; In Vitro Fertilization

• Registration Number: NCT04122729
• Lead Sponsor: Angelini Farmacéutica

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.

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 IVF/ICSI 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 (i.e., 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 Timeline

• Study Start: 2019-09-25
• Status Verified: 2019-10
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10
• Primary Completion: 2020-04
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genotype of the N680S polymorphism of the FSHR gene	Through study completion, an average of 1 year	Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples
Oocytes retrieved	Through study completion, an average of 1 year	Number of oocytes retrieved in each IVF/ICSI cycle with controlled ovarian stimulation used different nature of the FSH in each one (human FSH and recombinant FSH).

Secondary Outcome Measures

Name	Time	Method
Genotype of the N312S polymorphism of the LHCGR gene	Through study completion, an average of 1 year	Genotype of the N312S polymorphism of the LHCGR gene will be tested on blood samples

Trial Locations

Locations (12)

Hospital Clínico Universitario Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Príncipe de Asturias; 🇪🇸 Madrid, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain