Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)
Condition: PCO
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a prospective randomized clinical trial to compare the endocrine and metabolic
      effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women
      with PCOS
    

Detailed description: 
      This study is a prospective randomized clinical trial to compare the endocrine and metabolic
      effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women
      with PCOS.

      Polycystic ovary syndrome (PCOS) is characterized by menstrual irregularity,
      hyperandrogenism, chronic anovulation and enlarged ovaries with more than twelve peripherally
      located follicles less than 10 mm in diameter. Hyperinsulinemia is one of the diagnostic
      features of PCOS and patients with PCOS are found to have resistance to either endogenous or
      exogenous insulin. Different insulin sensitizing drugs used for improvement of
      hyperinsulinemia in PCOS subjects. Metformin (N dimethyl-biguanide) is an anti diabetic drug
      that increases glucose utilization in insulin sensitive tissues. Acarbose is an
      alfa-Glycosidase inhibitor acts by slowing the absorption of carbohydrates from the
      intestine, prevents Glucosidase activity in the brush-border of the intestinal mucosa,
      decreasing disaccharide digestion, reducing enteric monosaccharide absorption, so minimizing
      the postprandial rise of blood glucose concentration. The aim of present study is to compare
      the endocrine and metabolic effects of these two antidiabetic drugs (metformin vs. acarbose)
      in infertile overweight women with PCOS.

      The study population comprises all infertile patients with diagnosis of polycystic ovarian
      syndrome who were overweight (BMI>25Kg/m2). The PCO subjects will be recognized based on the
      Rotterdam criteria inclusive 1) irregular menstruation, 2) clinical and /or biochemical signs
      of hyperandrogenism, 3) polycystic ovaries (presence of 12 or more follicles in each ovary
      measuring 2-9 mm in diameter, and /or increased ovarian volume greater than 10 ml). Diagnosis
      of PCOS was confirmed by the presence two of three criteria beside the infertility.

      In this study all eligible patients will be randomly allocated into two study groups by a
      computerized randomization method:

      Acarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week,
      200 mg/ day in the second week and 300 mg/ day for the next 10 weeks). Metformin group will
      be received metformin. The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day
      in the second week and 1500 mg/ day for the next 10 weeks.

      Data collection will be performed by using questionnaire to be filled as per the available
      records and laboratory results. This study will be accomplished in Royan Institute on 50 PCO
      patients (25 patients in each group) and a continuous sampling method will be applied. Data
      analysis will be done through descriptive and perceptive statistical methods by using SPSS
      software version 15 for windows.
    

Intervention name(s): Metformin; Acarbose
Intervention type(s): Drug; Drug
Intervention description(s): The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day in the second week and 1500 mg/ day for the next 10 weeks.; Acarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week, 200 mg/ day in the second week and 300 mg/ day for the next 10 weeks).
Other intervention name(s): Metformin description; Acarbose description
Intervention MeSH terms: Metformin; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Metformin Acarbose pco infertility overweight