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Lead, Endocrine Disruption and Reproductive Outcomes

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00023101
First received: August 22, 2001
Last updated: March 22, 2006
Last verified: March 2006
History of Changes
  Purpose

This prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their husbands assesses endocrine dysfunction and adverse reproductive outcomes. Residing in two study areas in Shenyang, China, the women are married, 20 and 34 years of age, never smokers, have obtained permission to have a child, and have attempted to become pregnant over the course of the study. Lead exposure is defined by lead levels in blood samples collected at the baseline survey (both women and their husbands), first and second trimesters, and at delivery (both maternal and cord blood). Endocrine dysfunction is monitored by urinary hormone metabolites including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone conjugates (E1C), and pregnanediol-3-glucuronide (PdG). Reproductive endpoints include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery, and low birth weight.


Condition
Lead Poisoning
Infertility

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 800
Study Start Date: August 1996
  Eligibility

Ages Eligible for Study:   20 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

married women who:

  • currently reside in two study areas in Shenyang, China
  • between 20 and 34 years of age
  • never smokers
  • have obtained permission to have a child
  • are attempting to become pregnant over the course of the study.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00023101     History of Changes
Other Study ID Numbers: 8337-CP-001
Study First Received: August 22, 2001
Last Updated: March 22, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
lead
endocrine dysfunction

Additional relevant MeSH terms:
Infertility
Lead Poisoning
Poisoning
 Genital Diseases, Male
Genital Diseases, Female
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 22, 2013