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

NCT01600872 | Unknown

• 1 other identifier: WFH-TMU-PCOS-201112030
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Endocrine Disrupting Chemicals; Polycystic Ovary Syndrome

Keywords

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

Study Arms (2)

Gruop 1

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Normal health control and Women with reproductive endocrine disturbance menstrual irregularity, and/or polycystic ovary syndrome.

You may qualify if:

• Normal health control
• Women with reproductive endocrine disturbance menstrual irregularity, and/or polycystic ovary syndrome.

You may not qualify if:

• The following subjects were excluded from the study and control populations:
• women who experienced menarche less than 3 years prior to the start of the study;
• women who received hormones, antioxidants or drugs for major medical diseases such as diabetes or cardiovascular disease; and
• women who were older than 45.

Sponsors & Collaborators

• Ming-I Hsu: lead

Study Sites (1)

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ming I Hsu, MD

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Taipei Medical University WanFang Hospital

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 17, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

TW (1)