Clinical trial NCT01782911: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients
Official title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgen Profile
Inflammatory Markers
IVF Outcome
Keywords: Androgen
IVF
Resveratrol
PCOS.
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Effect of resveratrol on oocyte quality
timeFrame: 40 days
Secondary outcomes:
measure: Effect of resveratrol on testosterone levels.
timeFrame: 40 days
measure: Effects of resveratrol on inflammatory markers
timeFrame: 40 days
measure: Effects of resveratrol on the fertilization rate.
timeFrame: 40 days
measure: Effects of resveratrol on the pregnancy rate.
timeFrame: 40 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ivi Madrid
Study officials:
References:
citation: 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.