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Lead, Endocrine Disruption and Reproductive Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00023101
First Posted: August 24, 2001
Last Update Posted: March 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
  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

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

Estimated Enrollment: 800
Study Start Date: August 1996
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
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

ClinicalTrials.gov Identifier: NCT00023101     History of Changes
Other Study ID Numbers: 8337-CP-001
First Submitted: August 22, 2001
First Posted: August 24, 2001
Last Update Posted: March 23, 2006
Last Verified: March 2006

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

Additional relevant MeSH terms:
Infertility
Poisoning
Lead Poisoning
Genital Diseases, Male
Genital Diseases, Female
Chemically-Induced Disorders