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NCT00023101 Clinical Trial

Lead, Endocrine Disruption and Reproductive Outcomes

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00023101
Other study ID # 8337-CP-001
Secondary ID
Status Completed
Phase N/A
First received August 22, 2001
Last updated March 22, 2006
Start date August 1996

Study information
Verified date March 2006
Source National Institute of Environmental Health Sciences (NIEHS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 34 Years
Eligibility 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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS)
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