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

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ClinicalTrials.gov Identifier: NCT01782911
Recruitment Status : Suspended (Because the recruitment was difficult)
First Posted : February 4, 2013
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid

Brief Summary:
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 or disease Intervention/treatment Phase
Androgen Profile Inflammatory Markers IVF Outcome Dietary Supplement: Resveratrol Dietary Supplement: Placebo pills Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : February 1, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

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.



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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782911


Locations
Spain
Ivi Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid

Responsible Party: Juan A Garcia-Velasco, Medical Doctor, IVI Madrid
ClinicalTrials.gov Identifier: NCT01782911     History of Changes
Other Study ID Numbers: MAD-IO-01-2013-01
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Juan A Garcia-Velasco, IVI Madrid:
Androgen
IVF
Resveratrol
PCOS.

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