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Organophosphate Pesticides and Human Reproductive Health

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00046124
First received: September 20, 2002
Last updated: September 1, 2006
Last verified: September 2006
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

  Eligibility

Ages Eligible for Study:   20 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046124

Locations
China, Anhui
Anhui Medical University
Anqing City, Anhui, China
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046124     History of Changes
Other Study ID Numbers: 8957-CP-001
Study First Received: September 20, 2002
Last Updated: September 1, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013