Biological Effects of Treatment With Resveratrol in ART Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Dietary supplement: Resveratrol; Dietary supplement: Folic acid

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resveratrol; A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D	Dietary supplement: Resveratrol; 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)
Active Comparator: Folic acid; Folic Acid 400 ug	Dietary supplement: Folic acid; 400 mcg of folic acid

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

Collaborators and Investigators

• Sponsor: University Of Perugia
• Investigators: Principal Investigator: Sandro Gerli, MD, University Of Perugia

Publications and helpful links

General Publications

• Gerli S, Della Morte C, Ceccobelli M, Mariani M, Favilli A, Leonardi L, Lanti A, Iannitti RG, Fioretti B. Biological and clinical effects of a resveratrol-based multivitamin supplement on intracytoplasmic sperm injection cycles: a single-center, randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Aug 1:1-9. doi: 10.1080/14767058.2021.1958313. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Hematinics; Folic Acid; Resveratrol
• Other Study ID Numbers: SR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No