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

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ClinicalTrials.gov Identifier: NCT01600872
Recruitment Status : Unknown
Verified November 2013 by Ming-I Hsu, Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : May 17, 2012
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital

Brief 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.


Condition or disease
Oxidative Stress Endocrine Disrupting Chemicals Polycystic Ovary Syndrome

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Stress and BPA Impact With PCOS
Study Start Date : March 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Gruop 1
Group 2




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Normal health control and Women with reproductive endocrine disturbance menstrual irregularity, and/or polycystic ovary syndrome.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600872


Locations
Taiwan
WanFang Medical Center at Taipei Medical University Recruiting
Taipei City, Taiwan, 116
Contact: Ming I Hsu, MD    886-2-29307930 ext 2508    hsumingi@yahoo.com.tw   
Principal Investigator: Ming I Hsu, MD         
Sponsors and Collaborators
Ming-I Hsu
Investigators
Principal Investigator: Ming I Hsu, MD Taipei Medical University WanFang Hospital

Responsible Party: Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01600872     History of Changes
Other Study ID Numbers: WFH-TMU-PCOS-201112030
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Ming-I Hsu, Taipei Medical University WanFang Hospital:
EDCs
PCOS
TAS
TOS
ROS
Oxidative Stress, Endocrine-Disrupting Chemicals, Polycystic Ovary syndrome

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases