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

NCT ID: NCT01782911

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2013-02-01

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).

Conditions

Androgen Profile; Inflammatory Markers; IVF Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Resveratrol

Patients will be given 2 g of resveratrol a day from the onset of menses until ovarian pick-up.

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

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

Control

Patients will be given pills lacking medication from the onset of menses until the ovum pick-up.

Group Type: PLACEBO_COMPARATOR

Placebo pills

Intervention Type: DIETARY_SUPPLEMENT

The patients will take placebo for 40 days.

Interventions

Resveratrol

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo pills

The patients will take placebo for 40 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IVI Madrid

OTHER

Sponsor Role: lead

Responsible Party

Juan A Garcia-Velasco

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ivi Madrid

Madrid, , Spain

Countries

Spain

References

Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.

Reference Type: DERIVED

PMID: 32851663 (View on PubMed)

Other Identifiers

MAD-IO-01-2013-01

Identifier Type: -

Identifier Source: org_study_id