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NCT Number: NCT01782911

Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients

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).

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Key information

Conditions

Androgen Profile IVF Outcome Inflammatory Markers

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ivi Madrid

Madrid, 28023, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Dietary Supplement

The patients will take 2 g of resveratrol per day for 40 days.

Placebo pills

Dietary Supplement

The patients will take placebo for 40 days.

Primary outcomes

  1. Effect of resveratrol on oocyte quality

    Time frame: 40 days

Secondary outcomes

  1. Effect of resveratrol on testosterone levels.

    Time frame: 40 days

  2. Effects of resveratrol on inflammatory markers

    Time frame: 40 days

  3. Effects of resveratrol on the fertilization rate.

    Time frame: 40 days

  4. Effects of resveratrol on the pregnancy rate.

    Time frame: 40 days

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Official study title

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

Acronym: RES-IVF

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2013
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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