Clinical trial NCT01600872: Oxidative Stress and Bisphenol A (BPA) Impact With Polycystic Ovary Syndrome (PCOS)
Official title: Oxidative Stress and BPA Impact With PCOS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxidative Stress
Endocrine Disrupting Chemicals
Polycystic Ovary Syndrome
Keywords: EDCs
PCOS
TAS
TOS
ROS
Oxidative Stress, Endocrine-Disrupting Chemicals, Polycystic Ovary syndrome
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal health control and Women with reproductive endocrine disturbance menstrual irregularity, and/or polycystic ovary syndrome.

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: WanFang Medical Center at Taipei Medical University
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Ming I Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: