Trial Information

Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial

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.