Study of the effect of Metformin,Estrogen-progesterone pills versus their combination on thyroid profile and lipid profile in patients with Polycystic ovary syndrome attending a Tertiary Care Hospital

The present study will be a prospective observational study designed to be conducted in patients diagnosed with PCOS who are attending the outpatient department of Gynecology, NIMS. All adult patients (18 to 40 years old) who are newly diagnosed with PCOS and have shown no symptomatic benefit after being prescribed lifestyle modification for 3 months will be included in the study. The study will be conducted after obtaining the approval of the institutional ethics committee and will be conducted over a period of six months. The patients will be selected to participate in the study based on the eligibility criteria.

Study objectives and procedure will be explained to the patient. Written informed consent will be taken before the patients are recruited into the study after confirmation of diagnosis by a specialist physician. A structured case detail form will be used to record the patient-specific information, including personal data, demographic characteristics, past and current medical conditions and drug history.

Weight in (kg), height in (cm), and vital parameters will be measured for each patient. Body mass index (BMI) will be calculated as weight (kg)/height (m)2.

Five milliliters of venous blood will be collected from each participant for the biochemical tests. The blood samples will be drawn after overnight fasting in the morning (between 8 a.m. and 10 a.m. ).Standard laboratory procedures [Enzymatic colorimetric methods were used to determine total cholesterol (CHOD-PAP method), TGs (GPO-PAP method), HDL-C (Direct -PEG), and LDL-C levels using the cobas® 6000 analyzer Roche Diagnostics USA . Electrochemiluminescent immunoassays (ECLIA) for TSH, T4, and T3. FBS (GOD-POD)  and HbA1c using HPLC method]. Fasting blood sugar, glycosylated hemoglobin (HbA1c) will be assessed immediately using whole blood.

After taking the baseline readings as above ,the patients will randomized through the block randomisation and divided into three equal groups (n=30, each group). One group was prescribed with 1000 mg Metformin daily( Glyciphage SR 1gm), 2nd  group will be with combination of 1000 mg Metformin and Cyproterone acetate 2mg/ethinyl estradiol 0.035mg (Diane-35; 21 days per month followed by a 7-day pill-free period ) and 3rd group will be suggested Cyproterone acetate 2mg/ethinyl estradiol 0.035mg (Diane-35; 21 days per month followed by a 7-day pill-free period).

The patients will be followed up for a period of 3 months and the tests will be repeated at the end of  1 month and 3 months of the followup period. The medication of the patient will be either continued or terminated after the study based on the physician discretion and improvement of condition.