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

IVI Madrid

Status: Completed

Conditions: Androgen Profile; Inflammatory Markers; IVF Outcome

Treatments: Dietary Supplement: Placebo pills; Dietary Supplement: Resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01782911

MAD-IO-01-2013-01

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Resveratrol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Resveratrol

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo pills