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

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: NCT01113918
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital

Brief Summary:

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.

Condition or disease
Polycystic Ovary Syndrome

Study Type : Observational
Actual Enrollment : 627 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Study of Clinical Presentation and Cardiovascular Disease of Hyperandrogenism and Polycystic Ovary Syndrome in Obese and Non-obese Taiwanese Women
Study Start Date : February 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

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).

Primary Outcome Measures :
  1. Obese [ Time Frame: Who had visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center during April 2004 - March 2007. ]

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Polycystic Ovarian Syndrome(PCOS) women in wanfang hospital.

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.

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): NCT01113918

Taipei Medical University WanFang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital

Responsible Party: Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital Identifier: NCT01113918     History of Changes
Other Study ID Numbers: WFH-PCOS-97070
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases