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Lead, Endocrine Disruption and Reproductive Outcomes

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ClinicalTrials.gov Identifier: NCT00023101
Recruitment Status : Completed
First Posted : August 24, 2001
Last Update Posted : March 23, 2006
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)

Brief Summary:
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 or disease
Lead Poisoning Infertility

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : August 1996




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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.

ClinicalTrials.gov Identifier: NCT00023101     History of Changes
Other Study ID Numbers: 8337-CP-001
First Posted: August 24, 2001    Key Record Dates
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