- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114659
The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire
December 30, 2013 updated by: Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
The Study of Metabolic and Cardiac Vascular Risk in Patients With Polycystic Ovary Syndrome
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
169
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 116
- Taipei Medical University WanFang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Polycystic Ovary Syndrome(PCOS)
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Normal Control
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Women with PCOS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The correlation of PCOS betwwen metabolic and cardiovascular disease.
Time Frame: Participant were followed for 1 month in study period.
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Participant were followed for 1 month in study period.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ming-I Hsu, MD, Wan Fang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
April 29, 2010
First Submitted That Met QC Criteria
April 30, 2010
First Posted (Estimate)
May 3, 2010
Study Record Updates
Last Update Posted (Estimate)
January 1, 2014
Last Update Submitted That Met QC Criteria
December 30, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WFH-PCOS-98076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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