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Organophosphate Pesticides and Human Reproductive Health - Article


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Endocrine Diseases And Disorders

Endocrine Diseases; Endocrine Diseases (General); Multiple Endocrine Neoplasia 




Clinical Trial: Organophosphate Pesticides and Human Reproductive Health

This study is not yet open for patient recruitment.

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

Purpose

This prospective cohort study assesses the effects of exposure to organophosphate (OP) pesticides on adverse reproductive outcomes in both male and female agricultural workers in China. We will enroll women and their spouses, who are attempting to become pregnant, and observe reproductive endpoints including (1) semen parameters (concentration, total count, motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea, polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and irregular menstruation); (3) alterations in hormone patterns including reduced estrogen excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men; (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm delivery, low birth weight, and intrauterine growth retardation.

Condition
Fecundability
Spermatazoa Disorders
Menstruation Disorders
Endocrine Dysfunction

MedlinePlus related topics:  Menstruation

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Eligibility

Ages Eligible for Study:  20 Years   -   34 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • it must be the first marriage for both the woman and her husband and they must currently live in the study area;
  • the female's age must range from 20 to 34 years;
  • the couple has no plan to leave the study area in which they live for the next two years.

Exclusion Criteria:

  • those who are currently pregnant;
  • those who have tried unsuccessfully to get pregnant for at least 1 year;
  • those who are current or former smokers;
  • those who plan to move in the coming year.

Location Information


China, Anhui Province
      Anhui Medical University, Anqing City,  Anhui Province,  China

More Information

Study ID Numbers:  8957-CP-001
Record last reviewed:  September 2002
Last Updated:  October 13, 2004
Record first received:  September 20, 2002
ClinicalTrials.gov Identifier:  NCT00046124
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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Page Updated: September 30, 2005
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