Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)
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ClinicalTrials.gov Identifier: NCT01279512 |
Recruitment Status
:
Completed
First Posted
: January 19, 2011
Last Update Posted
: January 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
PCO | Drug: Metformin Drug: Acarbose | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Metformin reciepiants
Infertile overweight women with PCO who received Metformin
|
Drug: 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.
Other Name: Metformin description
|
Experimental: Acarbose reciepiants
Infertile overweight women with PCO who received Acarbose
|
Drug: Acarbose
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 Name: Acarbose description
|
- Weight reduction (BMI improvement) [ Time Frame: After 3 months of Metformin or Acarbose ]compare the effect of Metformin and Acarbose to weight reduction
- Fasting blood sugar (FBS) [ Time Frame: two hours post prandial blood sugar ]Compare the effect of Metformin and acarbose to fasting blood sugar reduction
- FSH [ Time Frame: 6 months ]compare the effect of Metformin and Acarbose to decrease the level of FSH
- LH [ Time Frame: 6 months ]compare the effect of Metformin and Acarbose to decrease the level of LH
- Estradiol [ Time Frame: 6 months ]compare the effect of Metformin and Acarbose to decrease the Esteradiol level
- Prolactin [ Time Frame: 6 months ]compare the effect of Metformin and Acarbose to decrease the Prolactin level
- Total testosterone [ Time Frame: 6 months ]compare the the effect of Metformin and Acarbose to decrease Total testosterone level
- Total cholesterol [ Time Frame: 6 months ]comparethe the effect of Metformin and Acarbose to decrease total cholesterol level
- triglyceride [ Time Frame: 6 months ]comparethe the effect of Metformin and Acarbose to decrease the triglyceride level
- High density Lipoprotein [ Time Frame: 6 months ]compare the the effect of Metformin and Acarbose to decrease high density lipoprotein
- Low density lipoprotein [ Time Frame: 6 months ]compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Poly Cystic Ovarian Syndrome patients
- Age < 40 years
- BMI > 25 kg/m2
Exclusion Criteria:
- Smoking
- Overt diabetes mellitus, hyperprolactinemia, diseases that would disturb clinical and hormonal responses (adrenal disease or tumors, ovarian tumors, thyroid disease)
- The use of hormonal medications or drugs that might interfere with carbohydrate metabolism over the last 6 months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279512
Iran, Islamic Republic of | |
Royan Institute | |
Tehran, Iran, Islamic Republic of |
Study Chair: | Ashraf Moini, MD | Scientific board | |
Study Director: | Elham Amirchaghmaghi, MD | Invetigator | |
Principal Investigator: | Zhila Ahmadi, BS.c | Investigator | |
Principal Investigator: | Bita Eslami, MPH | Investigator | |
Principal Investigator: | Ali asghar Akhlaghi, BS.c | Investigator | |
Principal Investigator: | Reza salmanyazdi, MLD | Investigator |
Additional Information:
Responsible Party: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT01279512 History of Changes |
Other Study ID Numbers: |
Royan-Emb-011 |
First Posted: | January 19, 2011 Key Record Dates |
Last Update Posted: | January 6, 2012 |
Last Verified: | August 2006 |
Keywords provided by Royan Institute:
Metformin Acarbose pco infertility overweight |
Additional relevant MeSH terms:
Overweight Polycystic Ovary Syndrome Body Weight Signs and Symptoms Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Gonadal Disorders Endocrine System Diseases Metformin Acarbose Hypoglycemic Agents Physiological Effects of Drugs Glycoside Hydrolase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |