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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Instituto Valenciano de Infertilidad, IVI VALENCIA.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Israel Ortega, Instituto Valenciano de Infertilidad, Spain Identifier:
First received: January 28, 2013
Last updated: January 31, 2013
Last verified: January 2013
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).

Condition Intervention Phase
Androgen Profile
Inflammatory Markers
IVF Outcome
Dietary Supplement: Resveratrol
Dietary Supplement: Placebo pills
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.

Resource links provided by NLM:

Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • Effect of resveratrol on oocyte quality [ Time Frame: 40 days ]

Secondary Outcome Measures:
  • Effect of resveratrol on testosterone levels. [ Time Frame: 40 days ]
  • Effects of resveratrol on inflammatory markers [ Time Frame: 40 days ]
  • Effects of resveratrol on the fertilization rate. [ Time Frame: 40 days ]
  • Effects of resveratrol on the pregnancy rate. [ Time Frame: 40 days ]

Estimated Enrollment: 70
Study Start Date: February 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01782911

Contact: Israel Ortega, Medical doctor 91 180 2900

Ivi Madrid Not yet recruiting
Madrid, Spain, 28023
Contact: IVI MADRID    91 180 29 00   
Principal Investigator: Israel Ortega, MD         
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

Responsible Party: Israel Ortega, Medical Doctor, Instituto Valenciano de Infertilidad, Spain Identifier: NCT01782911     History of Changes
Other Study ID Numbers: MAD-IO-01-2013-01
Study First Received: January 28, 2013
Last Updated: January 31, 2013

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents processed this record on May 22, 2017