Biological Effects of Treatment With Resveratrol in ART Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART)

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Dietary Supplement: Resveratrol
* Dietary Supplement: Folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a diagnosis of infertility BMI between 18 and 30 kg/m2, regular uterine cavity normal thyroid function normal blood parameters Exclusion Criteria: primary or secondary ovarian failure patients who adhered to Bologna Criteria (at least two of the following: advanced maternal age >40, less than 3 oocytes recovered in previous attempts, abnormal ovarian reserve test) presence of ovaries inaccessible to the oocyte pick-up, persistent ovarian cysts > 20 mm, presence of sactosalpinx heterologous fertilization, significant systemic disease or other situations unsuitable for ovarian stimulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel, single blind, grouped randomised, interventional clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol<br>A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D | Dietary Supplement: Resveratrol<br>* mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6<br>* Other names: Genante (S&R Farmaceutici S.p.A, Italy);|
| Active Comparator: Folic acid<br>Folic Acid 400 ug | Dietary Supplement: Folic acid<br>* 400 mcg of folic acid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follicles | Number of follicles >16 mm | 6 months | 
| oocytes | number of recovered oocytes | 6 months | 
| MII oocytes | percentage of metaphase II oocytes | 6 months | 
| fertilization | fertilization rates | 6 months | 
| embryos | number of embryos | 6 months | 
| blastocysts | number of blastocysts | 6 months | 
| gonadotropins days | duration of ovarian stimulation (days) | 6 months | 
| gonadotropins IU | dosage of gonadotropins (total IU during ovarian stimulation) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryos number | number of embryos per transfer | 18 months | 
| implantation | Implantation rate | 18 months | 
| pregnancy | clinical pregnancy rate | 18 months | 
| live birth | live birth rate | 18 months | 
| miscarriage | miscarriage rate | 18 months |