Investigating the effect of resveratrol administration on the expression of factors involved in mitochondrial function and biogenesis in granulosa cells of patients with PCOS who are candidates for ART: a three-blind randomized controlled clinical trial

Improving the symptoms of PCOS and the results of ART with the help of resveratrol and using this supplement to manage the treatment of patients

Forty patients with polycystic ovary syndrome are included in the project. Patients are randomly divided into two groups: the group receives eight hundred milligrams of resveratrol per day, and the group receives two placebo capsules for 60 days.

Sampling of Omid infertility clinic Performing experiments in the embryology laboratory of Tehran University of Medical Sciences

Patients with infertility caused by PCOS in the age range of 18-40 years. The diagnosis of PCOS will be based on the Rotterdam criteria and having at least two of the following three criteria: amenorrhea or oligomenorrhea, clinical/or biochemical signs of hyperandrogenism, polycystic ovary observation on ultrasound. (Ultrasound criterion for polycystic ovaries is the presence of at least 12 follicles with a diameter of 2 to 9 mm or an increase in ovarian volume of more than 10 cubic centimeters in the transvaginal ultrasound scan). Exclusion criteria: include pregnancy, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes, or impaired glucose tolerance. Also, people who have used antioxidant supplements, ovulation-inducing drugs, or drugs affecting the hormonal profile 6 months before the start of the plan will not be included in the plan.

Resveratrol drug user group Placebo consumer group

Evaluation of Sirtuin1, PGC1-α, UCP2 proteins expression Evaluation of PGC1-α, UCP2, Nrf1, TFAM gene expression Evaluation of antioxidant genes Assessment of intracellular ATP Determining the number of mtDNA copies Examination of TAC and TOS Investigating the antioxidant markers of follicular fluid Evaluation of ART results

Due to the addition of the investigation of antioxidant genes and the investigation of antioxidant indicators in follicular fluid and granulosa cells, which are related to mitochondrial function, these items were added to the primary outcome variables. Examination of chemical and clinical pregnancy is also done, which was added in the secondary outcome variables section.

Eligible patients after visiting the women's clinic respectively will be included in the study randomly. Block randomization It will be in such a way that within each floor, the method of blocks is used interchangeably. Blocks are binary and include AB and BA will be. The randomization tool will be a table of random numbers that will be used For the numbers 0 to 4 in the table of random numbers from the sequences A and B and for Numbers 5 to 9 are used from the sequence of B.A. It is necessary to mention the letter A It means the intervention group and the letter B means the control group. Direction Concealment We use random allocation concealment to The way that the assigned group is not known before assigning the individual. the door In this method, each random sequence is created on a card It will be registered and the cards will be placed in sealed envelopes in order They are placed. To preserve the random sequence, on The outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed inside box respectively A is placed. At the time of starting the registration of participants, based on The order of entry of qualified participants into the study, one of the envelopes The letter is opened, and the assigned group of that participant is revealed.

This study will be triple-blind and the patient, the researcher, and the statistical analyst Patients do not have any information about the type of group therapy and the person who deciphers the code It is outside the research team. The studied drug is resveratrol and placebo In a completely similar shape and appearance, each with 60 pieces in a package There are similar ones in the place of medicine based on random allocation to people The study will be presented. It should be noted that the medicinal content of each Which of the bottles was coded by a person outside the research package The bottles are labeled and the research team is aware of their interpretation do not have

All the data obtained in the research will be published in one of the relevant scientific journals.

Beginning of access spring 1403

Researchers working in academic institutions

The data of this research can be used as an adjuvant treatment method in patients with polycystic ovary syndrome undergoing IVF/ICSI.

Negar Ajabi Ardeh jani

By sending an email to the corresponding author.