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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Instituto Valenciano de Infertilidad, IVI VALENCIA
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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782911

Contacts
Contact: Israel Ortega, Medical doctor 91 180 2900 israel.ortega@ivi.es

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

No publications provided

Responsible Party: Israel Ortega, Medical Doctor, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov 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
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
Androgen
IVF
Resveratrol
PCOS.

Additional relevant MeSH terms:
Resveratrol
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014