The Study of Polycystic Ovary Syndrome (PCOS) and Questionnaire

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01256970
First received: December 7, 2010
Last updated: September 10, 2013
Last verified: September 2013
  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. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of Polycystic Ovary Syndrome (PCOS) and Questionnaire

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Obesity is the predominant predictor of impaired glucose tolerance and metabolic disturbance in polycystic ovary syndrome. [ Time Frame: Prospectively study in University teaching hospital from 31 August 2010 to 31 August 2011. ] [ Designated as safety issue: No ]
    To evaluate the contribution to glucose intolerance and metabolic syndrome of obesity combined with the diagnostic criteria of polycystic ovary syndrome (PCOS).


Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 306
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Polycystic Ovary Syndrome.
Polycystic ovary syndrome was diagnosed according to the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria: PCOM, chronic anovulation and hyperandrogenism.
Normal Control
Normal control women were women who did not present with any of three PCOS criteria.

  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: NCT01256970

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

No publications provided

Responsible Party: Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01256970     History of Changes
Other Study ID Numbers: WFH-PCOS-99075
Study First Received: December 7, 2010
Last Updated: September 10, 2013
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on August 19, 2014