To Study Polycystic Ovary Syndrome in Taiwanese Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01256944
First received: December 7, 2010
Last updated: December 8, 2015
Last verified: December 2015
  Purpose

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
Polycystic Ovary Syndrome
Metabolic Syndrome
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Study Polycystic Ovary Syndrome in Taiwanese Women

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Total Testosterone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Using serum total testosterone to represent the severity of hyperandrogenism.

  • BMI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    HOMA-IR = [fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)]/405.

  • Cholesterol [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Hypercholesterolemia was defined as >6 mmol / L.

  • Triglycerides [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Abnormal serum triglycerides defined as ≥ 1.7 mmol/L

  • HDL [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Enrollment: 290
Study Start Date: August 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256944

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

Responsible Party: Ming-I Hsu, MD, Attending Doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01256944     History of Changes
Other Study ID Numbers: WFH-PCOS-99041 
Study First Received: December 7, 2010
Results First Received: November 28, 2013
Last Updated: December 8, 2015
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
PCOS
DM
Hypertension
CVD

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

ClinicalTrials.gov processed this record on May 24, 2016