NCT01782911

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

Same day

First QC Date

January 28, 2013

Last Update Submit

August 19, 2019

Conditions

Androgen ProfileInflammatory MarkersIVF Outcome

Keywords

AndrogenIVFResveratrolPCOS.

Outcome Measures

Primary Outcomes (1)

  • Effect of resveratrol on oocyte quality

    40 days

Secondary Outcomes (4)

  • Effect of resveratrol on testosterone levels.

    40 days

  • Effects of resveratrol on inflammatory markers

    40 days

  • Effects of resveratrol on the fertilization rate.

    40 days

  • Effects of resveratrol on the pregnancy rate.

    40 days

Study Arms (2)

Resveratrol

EXPERIMENTAL

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

Dietary Supplement: Resveratrol

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo pills

Interventions

ResveratrolDIETARY_SUPPLEMENT

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

Resveratrol
Placebo pillsDIETARY_SUPPLEMENT

The patients will take placebo for 40 days.

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged from 18 to 40 years old.
  • PCOS diagnosis (according to Rotterdam criteria).
  • Mild or moderate male factor, tubal factor or unknown infertility.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivi Madrid

Madrid, 28023, Spain

Location

Related Publications (1)

  • 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.

    PMID: 32851663DERIVED

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 4, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

ES(1)