Biological Effects of Treatment With Resveratrol in ART Patients

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Dietary Supplement: Resveratrol; Dietary Supplement: Folic acid

• Registration Number: NCT04386499
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2020-03-11
• Status Verified: 2020-05
• Study Completion: 2020-05-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D
Folic acid	Folic acid	Folic Acid 400 ug

Primary Outcome Measures

Name	Time	Method
gonadotropins days	6 months	duration of ovarian stimulation (days)
blastocysts	6 months	number of blastocysts
fertilization	6 months	fertilization rates
MII oocytes	6 months	percentage of metaphase II oocytes
embryos	6 months	number of embryos
follicles	6 months	Number of follicles \>16 mm
gonadotropins IU	6 months	dosage of gonadotropins (total IU during ovarian stimulation)
oocytes	6 months	number of recovered oocytes

Secondary Outcome Measures

Name	Time	Method
embryos number	18 months	number of embryos per transfer
pregnancy	18 months	clinical pregnancy rate
implantation	18 months	Implantation rate
live birth	18 months	live birth rate
miscarriage	18 months	miscarriage rate

Trial Locations

Locations (1)

University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.; 🇮🇹 Perugia, Umbria, Italy