To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark GENANTE) on gamete quality in order to improve the reproductive process during ART.
The purpose of the study is to evaluate the effect of a new nutraceutical formulation containing resveratrol (trademark Genante) on gamete quality in order to improve the reproductive protocols during Assisted reproductive technology (ART) protocols. The study is a randomized, single blind, parallel, comparative, experimental study during the pre-treatment before in vitro fertilization-embryo transfer (IVF-ET). A total number of 100 patients will be enrolled: 50 patients with a pretreatment control group (control group) and 50 patients with experimental pretreatment study group (resveratrol group). Patients will be assigned to groups during the recruitment phase in a randomized manner. In the control group, the treatment will consist of taking 400 microg once a day of folic acid commonly suggested as part of clinical practice, while in the Resveratrol Group, patients will receive one tablet twice a day (two tablets/day) of Genante. It is specified that the pretreatment with Genante includes folic acid in accordance with the clinical practice, 400 total microg per day. Both treatments will last for 3 months before the IVF procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6
400 mcg of folic acid
University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
Perugia, Umbria, Italy
follicles
Number of follicles \>16 mm
Time frame: 6 months
oocytes
number of recovered oocytes
Time frame: 6 months
MII oocytes
percentage of metaphase II oocytes
Time frame: 6 months
fertilization
fertilization rates
Time frame: 6 months
embryos
number of embryos
Time frame: 6 months
blastocysts
number of blastocysts
Time frame: 6 months
gonadotropins days
duration of ovarian stimulation (days)
Time frame: 6 months
gonadotropins IU
dosage of gonadotropins (total IU during ovarian stimulation)
Time frame: 6 months
embryos number
number of embryos per transfer
Time frame: 18 months
implantation
Implantation rate
Time frame: 18 months
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pregnancy
clinical pregnancy rate
Time frame: 18 months
live birth
live birth rate
Time frame: 18 months
miscarriage
miscarriage rate
Time frame: 18 months