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IRCT138903244176N1 IRCT 2008-07-26 Hamedan university of medical sciences/Pro vice chancellor for research The effects of metformin on anthropometric, metabolic and hormonal changes in polycystic ovarian syndrome The effects of metformin on anthropometric, metabolic and hormonal changes in polycystic ovarian syndrome 2008-07-26 anticipated 28 Complete https://irct.ir/trial/4400 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Polycystic ovarian syndrome. All patients received 1500 mg metformin per day (500 mg three times a day) for 12 weeks orally.
public Dr Marzie Farimani Sanoee
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
Hamedan Iran (Islamic Republic of) +98 81 1827 6295 dr_farimani@yahoo.com; drneghab@yahoo.com Hamedan University of Medical Sciences scientific Dr Marzie Farimani Sanoee
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
Hamedan Iran (Islamic Republic of) +98 81 1827 6295 dr_farimani@yahoo.com; drneghab@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Reproductive age women referred due to infertility. Polycystic ovarian syndrome was defined as the presence of more than 12 cysts, 2–9 mm in diameter in one plane in at least one ovary and increased stroma, usually combined with increased ovarian volume >10 ml in sonography and clinical or biochemical hyperandrogenism. Subjects should have normal prolactin, thyroid, renal and hematological indices. No participant had received metformin or other hormonal treatment within the 3 months prior to study. Exclusion criteria included concurrent hormone therapy within the previous 6 weeks, any chronic disease that could interfere with the absorption, distribution, metabolism or excretion of metformin, renal or liver disease, being an smoker, doing intense physical activity, having lost 3 kg of body weight in the 2 months preceding the study 15 years 45 years Female E28.2 Polycystic ovarian syndrome Treatment - Drugs All patients received 1500 mg metformin per day (500 mg three times a day) for 12 weeks orally Waist to hip cicumference. Timepoint: 12 weeks. Method of measurement: physical exam. BMI. Timepoint: 12 weeks. Method of measurement: kilogramm/M2 physical exam. Menstrural cycles. Timepoint: 12 weeks. Method of measurement: History taking. Ovarian volume. Timepoint: 12 weeks. Method of measurement: Trans vaginal sonography. Testosterone. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. LDL. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. HDL. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. TG. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. Cholestrol. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. Homocysteine. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. CRP. Timepoint: 12 weeks. Method of measurement: Lab test, Blood sampling. Weight. Timepoint: 12weeks. Method of measurement: Physical exam. Blood pressure. Timepoint: 12weeks. Method of measurement: Physical exam. Acne. Timepoint: 12weeks. Method of measurement: Physical exam. Hirsutism. Timepoint: 12weeks. Method of measurement: Physical exam. LH. Timepoint: 12weeks. Method of measurement: Lab test, Blood sampling. FSH. Timepoint: 12weeks. Method of measurement: Lab test, Blood sampling. Estradiol. Timepoint: 12weeks. Method of measurement: Lab test, Blood sampling. 17OH Progesterone. Timepoint: 12weeks. Method of measurement: Lab test, Blood sampling. DHEAS. Timepoint: 12weeks. Method of measurement: Lab test, Blood sampling. Hamedan university of medical sciences/Pro vice chancellor for research Approved 2008-07-23 Hamedan university of medical science/Ethics committee School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street, Research committee Hamedan Iran (Islamic Republic of)