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To Study Polycystic Ovary Syndrome in Taiwanese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256944
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Ming-I Hsu, MD, Taipei Medical University WanFang Hospital

Brief Summary:

Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. Of those diagnosed with PCOS using the 2003 Rotterdam criteria, 61% fulfilled 1990 NIH criteria for unexplained hyperandrogenic chronic anovulation. The patient populations with the new phenotypes had less severe ovulatory dysfunction and less androgen excess than patients diagnosed using the 1990 NIH criteria. These findings might be common across all female populations with PCOS, whether in Oriental or Occidental countries. Data for clinical hyperandrogenism indicated that the prevalence of hirsutism in Taiwanese PCOS women is lower than that for Caucasians/Western women.

The extent of metabolic abnormalities in women with PCOS may vary with phenotype, age and ethnicity. Obesity represents a major risk factor for metabolic syndrome and insulin resistance. Approximately 40-50% of all women with PCOS are overweight or obese. Obese subjects with PCOS had a higher risk of developing oligomenorrhea, amenorrhea and biochemical hyperandrogenemia than non-obese women with PCOS. Moreover, obese women with PCOS had significantly more severe insulin resistance, lower serum LH levels, and lower LH-to-FSH ratios than non-obese women with PCOS. PCOS women in Taiwan presented with higher LH-to-FSH ratio and lower insulin resistance than PCOS women in Western Countries. However, the average body mass index (BMI) was significantly lower in Taiwanese PCOS women than Western women, which might partially explain the difference between these two populations in terms of clinical and biochemical presentations.

To further document the ethnic variation between women with PCOS in Taiwan and Western, the effect of obesity on the diagnosis and clinical presentations of PCOS-related syndromes should not be neglected in future studies. Therefore, the investigators plan to do this prospective study for evaluation the clinical and biochemical presentation of Taiwanese women with PCOS.

Condition or disease
Polycystic Ovary Syndrome Metabolic Syndrome Cardiovascular Disease

Detailed Description:

1. Method

  1. This study was approved by the Institutional Review Board of the Wan Fang Medical Center at Taipei Medical University (WF99041, approved August 2010) and performed at the Reproductive Endocrinology Clinic at the Wan Fang Medical Center from 31 August 2010 to 31 August 2011. The following women were excluded: (i) women who had been diagnosed with hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplasia, androgen-secreting tumor,Cushing's syndrome, disorders of the uterus and chromosomal anomalies; (ii) women who were less than three years past menarche or who were older than 45 years; (iii) women who received hormones or medication for major medical diseases (diabetes or cardiovascular disease); and (iv) women who had had ovarian cysts or ovarian tumors identified by ultrasonographic examination.
  2. Statistical analysis: We used chi-squared and Fisher's exact tests to perform categorical comparisons and ANOVA to compare the continuous variables. The means of more than two groups were compared using one-way ANOVA and post hoc Dunnett's t-test with equal variances not assumed.

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Study Type : Observational
Actual Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Study Polycystic Ovary Syndrome in Taiwanese Women
Study Start Date : August 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

The normal reproductive-aged women

Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:

  1. Oligo- or anovulation
  2. Clinical and/or biochemical signs of hyperandrogenism
  3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)

Primary Outcome Measures :
  1. Total Testosterone [ Time Frame: 1 year ]
    Using serum total testosterone to represent the severity of hyperandrogenism.

  2. BMI [ Time Frame: 1 year ]
    BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).

  3. Fasting Insulin [ Time Frame: 1 year ]
    A fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.

  4. Fasting Glucose [ Time Frame: 1 year ]

    Fasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes.

    World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L).

  5. Two Hour Glucose [ Time Frame: 1 year ]

    2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes.

    World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L).

  6. Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) [ Time Frame: 1 year ]
    HOMA-IR = [fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)]/405.

  7. Cholesterol [ Time Frame: 1 year ]
    Hypercholesterolemia was defined as >6 mmol / L.

  8. Triglycerides [ Time Frame: 1 year ]
    Abnormal serum triglycerides defined as ≥ 1.7 mmol/L

  9. HDL [ Time Frame: 1 year ]

    Metabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria:

    abdominal obesity (waist circumference >80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L.

  10. LDL [ Time Frame: 1 year ]

    Lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG).

    Abnormal LDL was ≧4.14mmol/L.

  11. Impaired Glucose Tolerance [ Time Frame: 1 years ]
    Impaired glucose tolerance was defined as two hour glucose levels of 7.8-11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be <7 mmol/L.

Biospecimen Retention:   Samples Without DNA
Blood sample

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Polycystic Ovary Syndrome(PCOS)

Inclusion Criteria:

  • women at reproductive age
  • women with PCOS and women without PCOS.

Exclusion Criteria:

  • young women who had their menarche less than 3 years
  • women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01256944

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Taipei Medical University-WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
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Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital

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Responsible Party: Ming-I Hsu, MD, Attending Doctor, Taipei Medical University WanFang Hospital Identifier: NCT01256944     History of Changes
Other Study ID Numbers: WFH-PCOS-99041
First Posted: December 9, 2010    Key Record Dates
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016
Last Verified: December 2015

Keywords provided by Ming-I Hsu, MD, Taipei Medical University WanFang Hospital:

Additional relevant MeSH terms:
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Ovarian Cysts
Cardiovascular Diseases
Metabolic Syndrome
Polycystic Ovary Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases