University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
Perugia, Umbria, 06156, Italy
NCT Number: NCT04386499
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.
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Notify Me18 year–42 year
Female
Interventional
Not applicable
Perugia, Umbria, 06156, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6
Other names: Genante (S&R Farmaceutici S.p.A, Italy)
400 mcg of folic acid
Time frame: 6 months
Number of follicles >16 mm
Time frame: 6 months
number of recovered oocytes
Time frame: 6 months
percentage of metaphase II oocytes
Time frame: 6 months
fertilization rates
Time frame: 6 months
number of embryos
Time frame: 6 months
number of blastocysts
Time frame: 6 months
duration of ovarian stimulation (days)
Time frame: 6 months
dosage of gonadotropins (total IU during ovarian stimulation)
Time frame: 18 months
number of embryos per transfer
Time frame: 18 months
Implantation rate
Time frame: 18 months
clinical pregnancy rate
Time frame: 18 months
live birth rate
Time frame: 18 months
miscarriage rate
University Of Perugia
Other
Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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