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The effects of metformin on anthropometric, metabolic and hormonal changes in polycystic ovarian syndrome

Not Applicable
Conditions
Polycystic ovarian syndrome.
Polycystic ovarian syndrome
Registration Number
IRCT138903244176N1
Lead Sponsor
Hamedan university of medical sciences/Pro vice chancellor for research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
28
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

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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.
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