The Impact of EDCs Relative Markers and Reproductive Hormone in Taiwanese Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01996631
First received: October 21, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

Oxidative stress(OS), inflammation, and endocrine-disrupting chemicals(EDC) were all thought as important markers that will impact on female reproductive function. However, the cause-result correlations between above parameters were still unclear. Investigator plans to design a study to evaluate the OS, inflammation, and EDC and their impact on the menstrual cycle and reproductive hormone in Taiwanese women. Ferritin is a ubiquitous intracellular protein that is essential for the regulation of iron homeostasis. Serum ferritin level is a widely available clinical biomarker used to estimate body iron status. Iron is a strong pro-oxidant, and high body iron levels are associated with an increased level of OS that may elevate the risk of type 2 diabetes. Mildly elevated body iron stores are associated with statistically significant elevations in glucose homeostasis indexes. Furthermore, patients with elevated iron stores present not only insulin resistance but also metabolic alterations that put them at increased risk of cardiovascular disease. Increased serum ferritin levels have been found in women with Polycystic Ovary Syndrome(PCOS). Serum ferritin were highly correlated with menstrual cycle and androgens level in women. Homocysteine, a sulfur-containing amino acid formed during the metabolism of methionine, exerts cytotoxic effects on the vascular endothelium. Hyperhomocysteinemia has been established as an independent risk factor for thrombosis and cardiovascular disease, and it may partially account for the increased risk of cardiovascular disease associated with insulin resistance. Elevated total plasma homocysteine levels have been established as an independent risk factor for thrombosis and cardiovascular disease. Studies related to homocysteine and PCOS have reported inconsistent results.

Chronic low-grade inflammation has emerged as a key contributor to the pathogenesis of PCOS and obesity. A dietary trigger such as glucose is capable of inciting OS and an inflammatory response from mononuclear cells of women with PCOS, and this phenomenon is independent of obesity. The correlation between inflammatory markers and reproductive endocrine disturbance and consequent complications should be important.Both OS and EDC had been associated with PCOS.

BPA, one of EDC, 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 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 OS. The first part of our study is aim to evaluate the OS impact on the biochemical parameters in women with PCOS; the secondary part of our study is to investigate the BPA on the clinical and biochemical of women with PCOS; finally, investigator plans to test the hypothesis that BPA might increase OS and then elevated ROS in women with menstrual disturbance, furthermore, the role of OS and BPA impact on insulin resistance and metabolic disturbance will be also investigated.

OS, inflammation, and EDCs are all important factors impact on the reproductive competence in women. To clarify above problems are critical importance. Investigator then conduct this study to demonstrate those problems. Study and control cases will be included. Serum total oxidant status, inflammatory biomarkers, total antioxidant status, BPA, and clinical/biochemical parameters will be obtained for all cases. OS and BPA will be evaluated with all clinical/biochemical parameters for all subjects.


Condition
Reproductive Aged.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Markers of OS, Inflammation, and EDCs and Impact on the Menstrual Cycle and Reproductive Hormone in Taiwanese Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Endocrine-disrupting chemicals [ Time Frame: The study will start from June 6, 2013 to May 31, 2016, up to 3 years. ] [ Designated as safety issue: No ]
    To study the correlation between serum markers of oxidative stress, inflammation, and endocrine-disrupting chemicals (EDCs) and their impact on the menstrual cycle and reproductive hormone in Taiwanese women.


Estimated Enrollment: 400
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients who are reproductive aged and come visit our OPD clinic, except postmenopausal and before menarche.

Criteria

Inclusion Criteria:

  • Reproductive aged women.

Exclusion Criteria:

  • Clinical diagnosed of congenital adrenal hyperplasia, androgen-secreting tumor, Cushing's syndrome, Asherman's syndrome, Mullerian agenesis, and chromosomal anomalies;
  • Menarche in 1 years and older than 49;
  • Hormones or drugs for major medical diseases used.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01996631

Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming I Hsu, MD Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Ming-I Hsu, Director, Principal Investigator, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01996631     History of Changes
Other Study ID Numbers: Hsu2013-TMU-JIRB 201301040
Study First Received: October 21, 2013
Last Updated: November 26, 2013
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on October 30, 2014