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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01600833
Other study ID # WFH-TMU-PCOS-201111006
Secondary ID
Status Completed
Phase N/A
First received May 15, 2012
Last updated November 6, 2013
Start date March 2012
Est. completion date March 2013

Study information

Verified date November 2013
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.


Recruitment information / eligibility

Status Completed
Enrollment 539
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

Exclusion Criteria:

- women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome)

- women who had menopause

- women with inadequate clinical/biochemical records

- women who had had ovarian cysts or ovarian tumors

- women who took hormone, medicine for Diabetes and/or cardiovascular disease.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan WanFang Medical Center at Taipei Medical University Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum ferritin levels in obese and non-obese women. The pathogenesis of increased iron stores correlated with insulin resistance and metabolic syndrome among obese and non-obese premenopausal women was different. The hypertriglyceridemia in women with PCOS might be associated with iron metabolism. the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011.
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