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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Taipei Medical University WanFang Hospital
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01600872
First received: May 15, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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
Oxidative Stress
Endocrine Disrupting Chemicals
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Stress and BPA Impact With PCOS

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gruop 1
Group 2

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 15, 2012
Last Updated: November 4, 2013
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Endocrine Disruptors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014