In Vitro Fertilization Clinical Trial
Official title:
Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation
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.
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.
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