Lead, Endocrine Disruption and Reproductive Outcomes

This study has been completed.

First Received: August 22, 2001 Last Updated: March 22, 2006 History of Changes

Sponsor:	National Institute of Environmental Health Sciences (NIEHS)
Information provided by:	National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:	NCT00023101

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:	Natural History, Longitudinal, Defined Population, Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Infertility Lead Poisoning Poisoning

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

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

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

lead
endocrine dysfunction

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Poisoning

Lead Poisoning
Disorders of Environmental Origin
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 27, 2009