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IRCT2016041827453N1 IRCT 2016-05-25 Vice chancellor for research of Tehran University of Medical Sciences The effects of Resveratrol on PCOS. - The effects of Resveratrol on expression of some ER stress pathway genes in granulosa cells and some circulating inflammatory markers in PCOS patients 2016-05-04 anticipated 40 Complete https://irct.ir/trial/22477 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -Randomized Controlled Trial. N/A Polycystic ovarian syndrome (PCOS). Intervention 1: For Intervention Group: Resveratrol (manufactured by Biovita company), Orally 1gr/day (2 Cap.) for 40 days from the beginning of the menstruation cycle till oocyte retrieval. Intervention 2: For Control Group: Placebo of Resveratrol, Orally 2 Cap. for 40 days from the beginning of the menstruation cycle till oocyte retrieval.
public Samaneh Brenjian
Poursina st. Tehran University of Medical sciences, Anatomy & Reproductive Biology Department
Tehran Iran (Islamic Republic of) 00982122005217 +98 21 2200 5217 sbrenjian@razi.tums.ac.ir smbrenjian@yahoo.com Tehran University of Medical sciences scientific Dr. Fardin Amidi
Poursina st., Tehran University of Medical Sciences, Embryology & Reproductive biology Department
Tehran Iran (Islamic Republic of) +98 21 2288 2402 amidifardin@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Infertility with documented PCOS based on Rotterdam criteria; 18-40 Y/O; If have male factor; it must be mild to moderate form, not non-obstructive azospermia; If have other female factor; only cervical & tubal factors are acceptable; Candidate for IVF Cycle; No insulin taking history; Not eating red grapes, pistachio, peanut and berries recently. Exclusion Criteria: Diseases due to obesity with unknown cause (Hypothyroidism, Coshing Syndrome); . FSH>10 at third day of the cycle; Severe endometriosis (Stage III or IV); Thyroid diseases; Congenital Adrenal Hyperplasia; Hyperprolactinemia; Ovarian Tumors; Taking Steroids, OCP and other drugs that affect ovarian function, insulin sensitivity or lipid metabolism in past 3 months (except routin PCOS therapy); SLE (Systemic Lupus Erythematosus) & autoimmune diseases; Systemic diseases like Metabolic Syndrome, Hyperlipidemias & cardiovascular diseases; Severe male factor like non-Obstructive Azospermia (sperm concentration < 5 mill/m); Patients who use vitrification method to avoid OHSS; Having alergy to some fruits like red grapes, pistachio and red berry; Insulin taking history 18 years 40 years Female E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs For Intervention Group: Resveratrol (manufactured by Biovita company), Orally 1gr/day (2 Cap.) for 40 days from the beginning of the menstruation cycle till oocyte retrieval. For Control Group: Placebo of Resveratrol, Orally 2 Cap. for 40 days from the beginning of the menstruation cycle till oocyte retrieval. ATF4 Expression. Timepoint: After follicle retrieval (Approximately 40 days after treatment). Method of measurement: Real-time relative quantification. ATF6 Expression. Timepoint: After follicle retrieval (Approximately 40 days after treatment). Method of measurement: Real-time relative quantification. CHOP Expression. Timepoint: After follicle retrieval (Approximately 40 days after treatment). Method of measurement: Real-time relative quantification. GRP78 Expression. Timepoint: After follicle retrieval (Approximately 40 days after treatment). Method of measurement: Real-time relative quantification. XBP1 Expression. Timepoint: After follicle retrieval (Approximately 40 days after treatment). Method of measurement: Real-time relative quantification. Inflammatory factors(IL-6, IL-18, IL-1beta, TNF-alpha, CRP). Timepoint: Before & After Intervention. Method of measurement: By ELISA Method. Insulin Resistance factors( glucose, insulin, homocystein, QUICKI, HOMA-IR). Timepoint: Before & After Intervention. Method of measurement: By Espectrophotometry Method. Biochemical Factors( FBS, cholestrole, Trigliseride, HDL, LDL). Timepoint: Before & After Intervention. Method of measurement: By Photometry Method. ROS (Reactive Oxygen Species: PC & MD). Timepoint: After follicle retrieval (Approximately 40 days after treatment) , Before & After Intervention. Method of measurement: By Espectrophotometry Method. NF-κB Expression. Timepoint: Before & After Intervention. Method of measurement: Real-time relative quantification. TAC (Total Antioxidant Capacity). Timepoint: After follicle retrieval (Approximately 40 days after treatment) , Before & After Intervention. Method of measurement: By Espectrophotometry Method. Number of retrieved Oocytes. Timepoint: After Intervention. Method of measurement: Count Under Microscope. Number of retrieved Mature Oocytes (MII). Timepoint: After Intervention. Method of measurement: Count Under Microscope. Quality of Retrieved Oocytes. Timepoint: After Intervention. Method of measurement: Based on WHO Criteria. Number of fertilized eggs. Timepoint: After Intervention. Method of measurement: Based on No. of 2PN oocytes. Fertilization rate. Timepoint: After Intervention. Method of measurement: fertilized egg number devided to retrieved oocyte number. Number of Cleavage embryos. Timepoint: After Intervention. Method of measurement: Count the Cleavage (8 Cells) embryos. Cleavage rate. Timepoint: After Intervention. Method of measurement: embryo number devided to fertilized egg number. High Quality Embryo Rate. Timepoint: After Intervention. Method of measurement: Count the Grade 1&2 of embryo quality. Chemical Pregnancy Rate. Timepoint: After Intervention. Method of measurement: B-hCG test. Clinical Pregnancy Rate. Timepoint: After Intervention. Method of measurement: Gestational Sac in Ultrasound. Vice chancellor for research of Tehran University of Medical Sciences Approved 2016-01-27 Ethics committee of Tehran University of Medical Sciences Tehran, Poursina St. Tehran Iran (Islamic Republic of)