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Home > "L" Clinical Trials Conditions > Lead, Endocrine Disruption and Reproductive Outcomes  Lead, Endocrine Disruption and Reproductive Outcomes
Lead, Endocrine Disruption and Reproductive Outcomes
For Condition: Lead Poisoning,Infertility
Status: No longer recruiting
Sponsor(s): National Institute of Environmental Health Sciences (NIEHS) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 20 Years/34 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 800
Location and Contact Information:
Additional Information:
Study ID Numbers: 8337-CP-001;
Study Start Date: August 1996
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023101
Other Infertility Studies:
1. Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
2. Bone Lead Levels and College Achievement Scores
3. Does Lead Burden alter Neuropsychological Development?
4. Lead Mobilization & Bone Turnover in Pregnancy/Lactation
5. Exposure, Dose, Body Burden and Health Effects of Lead
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Lead, Endocrine Disruption and Reproductive Outcomes
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