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IRCT20220815055705N1 IRCT 2023-11-16 Tehran University of Medical Sciences Resveratrol effect on ART outcome 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) 2023-10-23 anticipated 40 Complete https://irct.ir/trial/72913 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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), Blinding description: 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. 3 polycystic ovarian syndrome. Intervention 1: Intervention group: taking a daily dosage of 800mg resveratrol pills ( in 2 capsules of 400mg, one in the morning and one at noon) from mega resveratrol company for 60 days leading to puncture operation date. patients routine drug consumption like metformin is not affected. Intervention 2: Control group: taking a daily dosage of 800mg placebi pills ( in 2 capsules of 400mg, one in the morning and one at noon) for 60 days leading to puncture operation date. patients routine drug consumption like metformin is not affected. Yes - There is a plan to make this available What will be shared: All data obtained in the research will be published in one of the valid and related scientific journals. When: june 2024 To whom: Researchers working in academic institutions Conditions: The data of this study can be used as an adjuvant therapy in patients with polycystic ovary syndrome underwent IVF/ICSI. Where to obtain: Mohammadhosein Bagheri Email : mho3in77@yahoo.com phone : +989367542605 address: Tehran, Enghelab St., Qods St., Poursina, medicine faculty, embryology ward How to obtain: 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. Comments:
public Maryam Shabani Nashtaei
School of medicine, Tehran university of medical sciences, Poursina St., Qods St., Enghelab Blvd., Tehran
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3411 maryam.shabani.n@gmail.com Tehran University of Medical Sciences scientific Maryam Shabani Nashtaei
school of medicine, Pour Sina St., Qods St., Enghelab Blvd, Tehran
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3411 maryam.shabani.n@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients must be infertile due to PCOS and aged between 18 and 40. PCOS is diagnosed based on Rotterdam criteria and having 2 of 3 criteria is enough for diagnosis: amenorrhea or oligomenorrhea, clinical or biochemical hyperandrogenism manifestations, observation of cysts in ovary sonography (at least 12 follicles with diameter of 2 - 9 mm or an increase in ovary volume more than 10cm in tans-vaginal ultrasound radiography). 18 years 40 years Female pregnancy adrenal hyperplasia androgen secreting tumors hyperprolactinemia thyroid malfunction diabetes/glucose intolerance male infertility factors BMI > 30 taking anti-oxidant supplements less than 6 months prior to entering the study. taking ovulation stimulating drugs less than 6 months prior to entering the study. taking drugs with effect on hormone profile less than 6 months prior to entering the study. E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: taking a daily dosage of 800mg resveratrol pills ( in 2 capsules of 400mg, one in the morning and one at noon) from mega resveratrol company for 60 days leading to puncture operation date. patients routine drug consumption like metformin is not affected. Control group: taking a daily dosage of 800mg placebi pills ( in 2 capsules of 400mg, one in the morning and one at noon) for 60 days leading to puncture operation date. patients routine drug consumption like metformin is not affected. Caspase 3 gene expression. Timepoint: after 60 days of intervention. Method of measurement: real time PCR. Caspase 7 gene expression. Timepoint: after 60 days of intervention. Method of measurement: real time PCR. Survivin gene expression. Timepoint: after 60 days of intervention. Method of measurement: real time PCR. Serum testosterone. Timepoint: before/after intervention (60 days). Method of measurement: elisa. Serum insulin. Timepoint: before/after intervention (60 days). Method of measurement: elisa. Serum glucose. Timepoint: before/after intervention (60 days). Method of measurement: Enzyme kit. Serum sex hormone binding globulin. Timepoint: before/after intervention (60 days). Method of measurement: elisa. High-density lipoprotein cholesterol. Timepoint: before/after intervention (60 days). Method of measurement: Enzyme kit. Serum low-density lipoprotein. Timepoint: before/after intervention (60 days). Method of measurement: Enzyme kit. Total cholesterol. Timepoint: before/after intervention (60 days). Method of measurement: Enzyme kit. Triglyceride. Timepoint: before/after intervention (60 days). Method of measurement: Enzyme kit. Count and quality of oocyte. Timepoint: after 60 days of intervention. Method of measurement: counting, optical microscope. Count and quality of embryo. Timepoint: 48-72 hours after ICSI. Method of measurement: counting, optical microscope. Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: serum beta HCG test. Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: ultra-sound. Tehran University of Medical Sciences Approved 2023-10-02 Ethics committee of shari'ati hospital shari'ati hospital, jalal al ahmad st., jalal al ahmad hwy., jamshidieh district, tehran Tehran Tehran Iran (Islamic Republic of)