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Status unknownNCT01600872Updated Nov 6, 2013

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

An observational study in Oxidative Stress, Endocrine Disrupting Chemicals and Polycystic Ovary Syndrome, sponsored by Ming-I Hsu. Status unknown at 1 site in Taiwan. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by Ming-I Hsu · Observational

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Oxidative Stress
  • Endocrine Disrupting Chemicals
  • Polycystic Ovary Syndrome

Keywords

  • EDCs
  • PCOS
  • TAS
  • TOS
  • ROS
  • Oxidative Stress, Endocrine-Disrupting Chemicals, Polycystic Ovary syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 300 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

This is the only study on the registry with Ming-I Hsu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)

Groups and cohorts

  • Gruop 1
  • Group 2
06

Study locations

1 of 1 sites recruiting
  • WanFang Medical Center at Taipei Medical University
    Taipei City, 116, Taiwan
    • Ming I Hsu, MD · Contact · hsumingi@yahoo.com.tw · 886-2-29307930
    • Ming I Hsu, MD · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01600872
Lead sponsor
Ming-I Hsu
Responsible party
Ming-I Hsu (Taipei Medical University WanFang Hospital, Taipei Medical University WanFang Hospital) — Sponsor-investigator
First posted
May 17, 2012
Start date
Mar 2012
Primary completion
Apr 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Nov 6, 2013

Study contacts

Ming I Hsu, MD
principal investigator · Taipei Medical University WanFang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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