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IRCT20240122060763N1 IRCT 2024-02-01 Shiraz University of Medical Sciences A comparative study of the effects of two drugs, atorvastatin and glucophage, on plasma insulin resistance and follicular fluid changes in women with polycystic ovary syndrome. A comparative study of the effect of two drugs, atorvastatin and glucophage, on plasma insulin resistance and follicular fluid changes (the amount of antioxidants and oocyte growth factors) in women with polycystic ovary syndrome. 2024-02-22 anticipated 50 Complete https://irct.ir/trial/75112 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment method in this study will be permutation block method in such a way that A represents the person who receives the case and B represents the person who receives the control. receives This method is implemented by considering blocks of 2 so that the total number of possible binary permutations is equal to 2. 2 blocks including: AB and BA. The desired random list of 50 items, which includes 25 blocks of 2 items (total number of samples = 50 x 25) is generated and the order of allocation of each of the methods to the samples participating in the study is determined. The way to use the table of random numbers is that a starting point is randomly selected and 25 numbers are randomly selected (row or column) and the permutation assigned to each number is noted (the order of placement of the permutations next to each other from left to right will be to the right) and how to allocate all 50 people to two groups A and B will be determined. 3 Women with polycystic ovary syndrome. Intervention 1: Intervention group: Using atorvastatin in the amount of 40 mg every night after dinner for 6 weeks until the day of egg retrieval. Intervention 2: Control group: Taking 500 mg Glucophage 3 times a day after meals for 6 weeks until the day of egg retrieval. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Sanaz Alaee
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Shiraz Iran (Islamic Republic of) 7154895379 +98 71 3725 5699 alaee@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Sanaz Alaei
Modares Boulevard, Azadegan Boulevard, Alley 5, Reza Building 4, 3rd floor
Shiraz Iran (Islamic Republic of) 7154895379 +98 71 3725 5699 Alaee@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) According to the Rotterdam criteria (the presence of two criteria for the diagnosis of polycystic ovaries 1- oligomenorrhea or amenorrhea 2- clinical or laboratory findings of hyperandrogenism 3- the presence of polycystic ovaries in ultrasound examination) the diagnosis of PCOS has been confirmed in them Age 18-40 years Absence of thyroid disorder, Cushing's syndrome, hyperprolactinoma Absence of kidney disease, liver disease, diabetes, lipid profile disorder No history of cardiovascular disease and blood pressure Not using ovarian stimulation drugs or hormonal drugs in the last 3 months Not using insulin-sensitive drugs or lipid profiles in the last 3 months not smoking non-alcoholic No use of addictive substances Not having breast cancer Absence of medicinal contraindications Absence of malabsorption Having a minimally abnormal amount of insulin resistance 18 years 40 years Female Body mass more than 30 kg/m2 Body mass less than 19 kg/m2 E28.2 Treatment - Drugs Treatment - Drugs Intervention group: Using atorvastatin in the amount of 40 mg every night after dinner for 6 weeks until the day of egg retrieval. Control group: Taking 500 mg Glucophage 3 times a day after meals for 6 weeks until the day of egg retrieval. The amount of insulin resistance is measured based on the HOMA index. The amount of fasting insulin is multiplied by the amount of fasting sugar and the resulting number is divided by 22.5, which is equal to 1 in normal people. Timepoint: The amount of insulin resistance is measured once before the intervention in two groups and again after the intervention in two groups. Method of measurement: Measuring insulin resistance: the amount of fasting insulin is multiplied by the amount of fasting sugar and the resulting number is divided by 22.5, which is equal to 1 in normal people. Changes of MDA (malon-di-aldehyde) in follicular fluid. Timepoint: After the intervention, it is measured in the follicular fluid and compared with the standard value. Method of measurement: Using a commercial measuring kit of malondialdehyde kiazist. Examination of TAC (Total Antioxidant Capacity) in follicular fluid. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Using a commercial kit to measure TAC is key. Investigation of catalase changes in follicular fluid. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Using the commercial kit for measuring catalase of Kiazist company. Measuring changes in oocyte growth factor (GDF-9) in granulosa cells. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Through the expression of the gene of this protein with the help of Realtime PCR. Changes in oocyte growth factor (BMP15) in granulosa cells. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Through gene expression and Realtime PCR. Shiraz University of Medical Sciences Approved 2024-01-08 Ethics Committee of Shiraz Medical Sciences Faculty of Modern Sciences, Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)