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

Inflammatory Markers Clinical Trial

— RES-IVF  

Official title:

Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782911
• Other study ID #: MAD-IO-01-2013-01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: February 1, 2013

Study information

• Verified date: August 2019
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 1, 2013
• Est. primary completion date: February 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Androgen Profile
• Inflammatory Markers
• IVF Outcome

Intervention

Dietary Supplement:
• Resveratrol
The patients will take 2 g of resveratrol per day for 40 days.
• Placebo pills
The patients will take placebo for 40 days.

Locations

Country	Name	City	State
Spain	Ivi Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of resveratrol on oocyte quality		40 days
Secondary	Effect of resveratrol on testosterone levels.		40 days
Secondary	Effects of resveratrol on inflammatory markers		40 days
Secondary	Effects of resveratrol on the fertilization rate.		40 days
Secondary	Effects of resveratrol on the pregnancy rate.		40 days