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

NCT ID: NCT01600872

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oxidative Stress Endocrine Disrupting Chemicals Polycystic Ovary Syndrome

Keywords

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EDCs PCOS TAS TOS ROS Oxidative Stress, Endocrine-Disrupting Chemicals, Polycystic Ovary syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gruop 1

No interventions assigned to this group

Group 2

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ming-I Hsu

OTHER

Sponsor Role lead

Responsible Party

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Ming-I Hsu

Taipei Medical University WanFang Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ming I Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University WanFang Hospital

Locations

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WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Ming I Hsu, MD

Role: primary

Other Identifiers

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WFH-TMU-PCOS-201112030

Identifier Type: -

Identifier Source: org_study_id