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To Study Polycystic Ovary Syndrome in Taiwanese Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256944
First Posted: December 9, 2010
Last Update Posted: January 13, 2016
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.
Information provided by (Responsible Party):
Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
December 7, 2010
December 9, 2010
November 28, 2013
January 13, 2016
January 13, 2016
August 2010
June 2013   (Final data collection date for primary outcome measure)
  • Total Testosterone [ Time Frame: 1 year ]
    Using serum total testosterone to represent the severity of hyperandrogenism.
  • 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).
  • 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.
  • 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).

  • 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).

  • 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.
  • Cholesterol [ Time Frame: 1 year ]
    Hypercholesterolemia was defined as >6 mmol / L.
  • Triglycerides [ Time Frame: 1 year ]
    Abnormal serum triglycerides defined as ≥ 1.7 mmol/L
  • 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.

  • 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.

  • 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.
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Complete list of historical versions of study NCT01256944 on ClinicalTrials.gov Archive Site
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To Study Polycystic Ovary Syndrome in Taiwanese Women
To Study Polycystic Ovary Syndrome in Taiwanese Women

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Blood sample
Probability Sample
Polycystic Ovary Syndrome(PCOS)
  • Polycystic Ovary Syndrome
  • Metabolic Syndrome
  • Cardiovascular Disease
Not Provided
  • Control
    The normal reproductive-aged women
  • PCOS

    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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
15 Years to 45 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01256944
WFH-PCOS-99041
No
Not Provided
Not Provided
Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
December 2015