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

Study Overview
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Brief Summary
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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).

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

Conditions
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Androgen Profile, Inflammatory Markers, IVF Outcome

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Dietary Supplement: Placebo pills


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol<br>Patients will be given 2 g of resveratrol a day from the onset of menses until ovarian pick-up. | Dietary Supplement: Resveratrol<br>* The patients will take 2 g of resveratrol per day for 40 days.<br>|
| Placebo Comparator: Control<br>Patients will be given pills lacking medication from the onset of menses until the ovum pick-up. | Dietary Supplement: Placebo pills<br>* The patients will take placebo for 40 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of resveratrol on oocyte quality |  | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Androgen, Resveratrol, PCOS.