Oxidative Stress and Bisphenol A (BPA) Impact With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Official title:

Oxidative Stress and BPA Impact With PCOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01600872
• Other study ID #: WFH-TMU-PCOS-201112030
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2012
• Last updated: November 4, 2013
• Start date: March 2012
• Est. completion date: April 2014

Study information

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

Clinical Trial Summary

Both oxidative stress and Bisphenol A (BPA) had been associated with polycystic ovary syndrome (PCOS). BPA, one of endocrine-disrupting chemicals (EDCs), is an environmental estrogen used in the synthesis of plastics, is a "high-volume production" chemical with widespread human exposure. BPA was been reported in several female reproductive disturbance. However, the pathological pathway of BPA impact on female reproductive system had not been well-understood. Reactive oxygen species (ROS) have a role in the modulation of gamete quality and gamete interaction. Persistent and elevated generation of ROS leads to a disturbance of redox potential that in turn causes oxidative stress (OS). The first part of The investigators study is aim to evaluate the oxidative stress impact on the biochemical parameters in women with PCOS; the secondary part of the investigators study is to investigate the BPA on the clinical and biochemical of women with PCOS; finally, the investigators plan to test the hypothesis that BPA might increase oxidative stress and then elevated ROS in women with menstrual disturbance, furthermore, the role of oxidative stress and BPA impact on insulin resistance and metabolic disturbance will be also investigated.

Study and control cases will be included. Serum total oxidant status (TOS), total antioxidant status (TAS), Bisphenol A (BPA), and clinical/biochemical parameters will be obtained for all cases. Oxidative stress and BPA will be evaluated with all clinical/biochemical parameters for all subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Normal health control

2. Women with reproductive endocrine disturbance menstrual irregularity, and/or polycystic ovary syndrome.

Exclusion Criteria:

• The following subjects were excluded from the study and control populations:

1. women who experienced menarche less than 3 years prior to the start of the study;

2. women who received hormones, antioxidants or drugs for major medical diseases such as diabetes or cardiovascular disease; and

3. women who were older than 45.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endocrine Disrupting Chemicals
• Oxidative Stress
• Polycystic Ovary Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ming-I Hsu

Country where clinical trial is conducted

Taiwan,