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

This study is not yet open for participant recruitment.
Verified January 2013 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by (Responsible Party):
Israel Ortega, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01782911
First received: January 28, 2013
Last updated: January 31, 2013
Last verified: January 2013

January 28, 2013
January 31, 2013
February 2013
April 2013   (final data collection date for primary outcome measure)
Effect of resveratrol on oocyte quality [ Time Frame: 40 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01782911 on ClinicalTrials.gov Archive Site
  • Effect of resveratrol on testosterone levels. [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Effects of resveratrol on inflammatory markers [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Effects of resveratrol on the fertilization rate. [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Effects of resveratrol on the pregnancy rate. [ Time Frame: 40 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Androgen Profile
  • Inflammatory Markers
  • IVF Outcome
  • Dietary Supplement: Resveratrol
    The patients will take 2 g of resveratrol per day for 40 days.
  • Dietary Supplement: Placebo pills
    The patients will take placebo for 40 days.
  • Experimental: Resveratrol
    Patients will be given 2 g of resveratrol a day from the onset of menses until ovarian pick-up.
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Control
    Patients will be given pills lacking medication from the onset of menses until the ovum pick-up.
    Intervention: Dietary Supplement: Placebo pills
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
Not Provided
April 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact: Israel Ortega, Medical doctor 91 180 2900 israel.ortega@ivi.es
Spain
 
NCT01782911
MAD-IO-01-2013-01
Yes
Israel Ortega, Instituto Valenciano de Infertilidad, Spain
Instituto Valenciano de Infertilidad, Spain
Not Provided
Not Provided
Instituto Valenciano de Infertilidad, Spain
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP