The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01114659
First received: April 29, 2010
Last updated: December 30, 2013
Last verified: December 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 Metabolic and Cardiac Vascular Risk in Patients With Polycystic Ovary Syndrome

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The correlation of PCOS betwwen metabolic and cardiovascular disease. [ Time Frame: Participant were followed for 1 month in study period. ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with PCOS
Normal Control

  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: NCT01114659

Locations
Taiwan
Taipei Medical University WanFang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming-I Hsu, MD Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Ming-I Hsu, MD, Attending Doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01114659     History of Changes
Other Study ID Numbers: WFH-PCOS-98076
Study First Received: April 29, 2010
Last Updated: December 30, 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 26, 2014