Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients (RES-IVF)

August 19, 2019 updated by: Juan A Garcia-Velasco, IVI Madrid

Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.

Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • IVI Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged from 18 to 40 years old.
  • PCOS diagnosis (according to Rotterdam criteria).
  • Mild or moderate male factor, tubal factor or unknown infertility.

Exclusion Criteria:

  • Follicle stimulation hormone (third of day of menstruation) > 10 milli international units/L.
  • Endometriosis (III o IV).
  • Congenital adrenal hyperplasia.
  • Cushing syndrome.
  • Hyperprolactinemia.
  • Thyroid disease.
  • Androgenic hormone secretor tumors.
  • Patients included in this trial did not take either oral contraceptives, steroids or other medications that could modify the ovarian function, insulin sensitivity or lipid metabolism 3 months before the onset of the trial.
  • Severe male factor (sperm concentration < 5 mill/ml).
  • Patients undergoing oocyte vitrification to avoid hyperstimulation syndrome will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol
Patients will be given 2 g of resveratrol a day from the onset of menses until ovarian pick-up.
Dietary supplement: Resveratrol
The patients will take 2 g of resveratrol per day for 40 days.
Placebo Comparator: Control
Patients will be given pills lacking medication from the onset of menses until the ovum pick-up.
Dietary supplement: Placebo pills
The patients will take placebo for 40 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of resveratrol on oocyte quality
Time Frame: 40 days
40 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of resveratrol on testosterone levels.
Time Frame: 40 days
40 days
Effects of resveratrol on inflammatory markers
Time Frame: 40 days
40 days
Effects of resveratrol on the fertilization rate.
Time Frame: 40 days
40 days
Effects of resveratrol on the pregnancy rate.
Time Frame: 40 days
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAD-IO-01-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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