evaluation of resveratrol effect on the expression of the apoptosis-associated genes in granulosa cells of PCOS patients applicant to ART (triple-blinded randomized controlled trial)

evaluation of resveratrol effect on the expression of the apoptosis-associated genes in granulosa cells of PCOS patients applicant to artificial reproductive techniques (ART)

A clinical trial with two groups of treatment and control (drug and placebo) with equal numbers in each group, triple-blind, randomized (table of random numbers) and concealed (code instead of people's names), phase 3 on a sample of 40 patients.

Admission is done in Shariati Hospital، Tehran، infertility ward. Patients participating in the experiment receive either medication or a placebo for 60 days leading up to the day of the egg pick-up operation. Both the patient and the research team only see the code or color of the drug package and do not know its content. The data analyst is also unaware of the study side of the subjects (either real drug or placebo).

inclusion criteria: diagnosed with PCOS; aged between 18 and 40 yo; exclusion criteria: pregnancy; adrenal hyperplasia; androgen-secreting tumors; hyperprolactinemia; thyroid malfunction; diabetes/glucose intolerance; male infertility factors; BMI > 30; taking anti-oxidant supplements, ovulation stimulating drugs and drugs with effect on hormone profile less than 6 months prior to entering the study.

treatment group: containing 20 patients each taking 800mg of resveratrol in form of pills for 60 days in a row. control group: containing 20 patients taking similar pills without resveratrol substance for 60 days in a row.

expression of caspase3, 7 and survivin genes; ART outcomes; lipid profile, insulin and glucose; sex hormones.

If patients meet the criteria of the study and sign an informed consent form they will be divided into two groups after referring to the infertility ward of the hospital. using the random block method and using a random number table (numbers 0 to 4 in group A and numbers 5 to 9 in group B). In this way, it is not known before the allocation of the individual of that person's group. In this method, each of the randomly obtained sequences is written on a card and the cards are placed in sealed envelopes respectively. In order to maintain a random sequence, each envelope is numbered in the same order. Finally, the envelope is sealed and placed in a box. At the time of inclusion of eligible patients, one of the letter envelopes is opened and the allocated group of that patient is revealed. Hiding will also be done to prevent directional selection by replacing the names of people with code (numbers).

The original drug and placebo will be divided into the same dose, number, and container and then determined by someone outside of the experiment by a different code or color. (The information contained in the envelope sealed will be kept with this person until the end of the experiment.) Patients who participated in the experiment without knowing the contents of the packages (drug or placebo) will receive one of the two packages and will be given as per instructions. None of the people involved in the study will be informed of the contents of the packages until the end of the data collection and analysis.

All data obtained in the research will be published in one of the valid and related scientific journals.

june 2024

Researchers working in academic institutions

The data of this study can be used as an adjuvant therapy in patients with polycystic ovary syndrome underwent IVF/ICSI.

Mohammadhosein Bagheri Email : mho3in77@yahoo.com phone : +989367542605 address: Tehran, Enghelab St., Qods St., Poursina, medicine faculty, embryology ward

By sending an email to the corresponding author. The applicant can receive the required information within one week if the information is available by specifying the affiliated scientific-educational center.