Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Expression of CVD and HA Between Obesity and Non-obesity Polycystic Ovary Syndrome (PCOS) Women in Taiwan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01113918
First received: April 28, 2010
Last updated: September 29, 2013
Last verified: September 2013

April 28, 2010
September 29, 2013
February 2009
February 2010   (final data collection date for primary outcome measure)
Obese [ Time Frame: Who had visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center during April 2004 - March 2007. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01113918 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Expression of CVD and HA Between Obesity and Non-obesity Polycystic Ovary Syndrome (PCOS) Women in Taiwan
A Study of Clinical Presentation and Cardiovascular Disease of Hyperandrogenism and Polycystic Ovary Syndrome in Obese and Non-obese Taiwanese Women

Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are potentially dangerous in women health. Early diagnosis and prevention is very important to the PCOS patients.

Obesity is the most potential risk of threat to health of populations. There is a major impact of obesity on the PCOS related disorders. Insulin resistance and distribution of adipose tissue were thought to be the important risk factors of cardiovascular and metabolic syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team. We recently published in "Fertility and Sterility" about the clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is important to know that some clinical presentation of PCOS might have ethic variance. Insulin resistance was reported as another candidate that might have ethic variance.We had reported about 40% women in PCOS women were obese, it is similar with previous literature reported. Obesity is a major factor that could be controlled during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS women would be facing the risks of diabetes and metabolic syndrome.We thought like to evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.

Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of cardiovascular disease, we would like to know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research which including gynecological endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This team had been working well for more that 4 years.

We hope we can make a contribution to the study and treatment of PCOS in Taiwan.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Polycystic Ovarian Syndrome(PCOS) women in wanfang hospital.

Polycystic Ovary Syndrome
Not Provided
  • Obsity PCOS Women

    Polycystic ovary syndrome (PCOS) was diagnosed according to the European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM) case definition which requires presentation of signs and/or symptoms of a minimum of 2 of the following 3 criteria: polycystic ovary morphology (PCOM), oligomenorrhea or amenorrhea (Oligo-An), androgen excess (HA).

    Body mass index (BMI) was defined as body weight in kilograms divided by body height in meters squared (kg/m2). Obesity was defined as BMI≥25 kg/m2, according to the Asia-Pacific definition.

  • Non-obesity PCOS Women
    The subjects BMI were less than ≥25 kg/m2 and out of criteria of PCOS by European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
627
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • women who had visited the Reproductive Endocrinology Clinic at Taipei Medical University - Wan Fang Medical Center during April 2004 - March 2007 with the chief complaints of menstrual irregularities, infertility, acne/or hirsutism.

Exclusion Criteria:

  • women who had been diagnosed with androgen-secreting tumors.
  • girls who had their menarche less than 3 years prior to the study, or who older than 40.
  • women with inadequate clinical/biochemical records.
Female
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01113918
WFH-PCOS-97070
No
Ming-I Hsu, 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
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP