metformin
Drug850 mg orally twice daily for 6 months
Other names: glucophage
NCT Number: NCT02568488
Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks), 2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels 3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).
the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.
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Notify Me18 year–33 year
Female
Interventional
Phase 4
Forty eight PCOS patients attending the OBGYN clinic at kasr al aini were included in the study. The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.
The effect of metformin on PCOS patients regarding its clinical and radiological parameters was also assessed. Each patient was asked to keep a diary of her menstrual periods over the study period; to elicit if there could be an effect by metformin on the regulation of menstrual cycles secondary to improvement of ovarian function as a result of improving insulin resistance in such patients. The effect of metformin on ovarian morphology by ultrasound was also assessed at baseline, 3months and 6 months of the study period; ovarian volume and number of follicles was noted down at each visit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
850 mg orally twice daily for 6 months
Other names: glucophage
Time frame: Change from Baseline at 3 and 6 months
total and free testosterone
Time frame: Change from Baseline at 3 and 6 months
serum insulin (fasting and 2 hr postprandial)
Time frame: Change from Baseline at 3 and 6 months
ovarian volume and number of follicles
Time frame: Change from Baseline at 3 and 6 months
Time frame: Change from Baseline at 3 and 6 months
Time frame: Change from Baseline at 3 and 6 months
Ahmed Maged
Other
The Effect of Metformin on Serum Insulin, Androgens and AMH in PCOS Patients
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