N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
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|ClinicalTrials.gov Identifier: NCT04122729|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
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.
|Condition or disease|
|In Vitro Fertilization Controlled Ovarian Stimulation|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation|
|Actual Study Start Date :||September 25, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
- Oocytes retrieved [ Time Frame: 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).
- Genotype of the N680S polymorphism of the FSHR gene [ Time Frame: Through study completion, an average of 1 year ]Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples
- Genotype of the N312S polymorphism of the LHCGR gene [ Time Frame: Through study completion, an average of 1 year ]Genotype of the N312S polymorphism of the LHCGR gene will be tested on blood samples
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122729
|Contact: Cristina Macarrilla||+34 932 534 email@example.com|
|Hospital Universitario Fundación Alcorcón||Recruiting|
|Alcorcón, Madrid, Spain|
|Contact: Berta Mª Martín, PhD|
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|Hospital General Universitario Gregorio Marañon||Recruiting|
|Contact: Miguel Caballero, PhD|
|Hospital Universitario 12 de Octubre||Recruiting|
|Contact: Laura de la Fuente, PhD +34 917 452 520|
|Hospital Universitario La Paz||Recruiting|
|Contact: Sonia Lobo, PhD +34 917 277 219|
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|Contact: Irene Heras, PhD|
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|Contact: José Mª Rubio, PhD|
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|Contact: Ana Casas, PhD|
|Study Director:||María Carrera, PhD||Hospital Universitario 12 de Octubre|