Reproductive Techniques, Assisted Clinical Trial
Official title:
Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH Versus Recombinant FSH in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism. Genodon Trial
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.
The aim of this study is to determine whether the number of oocytes obtained in women oocyte
donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene
polymorphism.
This is an exploratory, prospective, randomized, comparative, open trial with control group
treated according to the usual therapeutic approach in our institution for ovarian
stimulation for oocyte donors prospective exploratory study control group .
Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for
the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor
members of each group will be randomly assigned to receive daily 225 IU of recombinant or
urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid
unintentional bias, allocation to treatment group will take place at the time in which
ovarian stimulation according begins with a list of random allocation of treatments for each
of the groups (SS , SN and NN) that will be associated the code of the patient and are
prepared and will be available before the start of the study. The code assignment and
treatment of the patient will consecutively in the order of the list and must be recorded in
the medical history of the patient. The next scheduled patient will be assigned to the code
and the next immediate treatment in this list.
The protocol for controlled ovarian stimulation in oocyte donors, will be performed always
according to the usual protocol in the Instituto Bernabeu.
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