Organophosphate Pesticides and Human Reproductive Health

September 1, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Anqing City, Anhui, China
        • Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 20, 2002

First Submitted That Met QC Criteria

September 20, 2002

First Posted (Estimate)

September 23, 2002

Study Record Updates

Last Update Posted (Estimate)

September 4, 2006

Last Update Submitted That Met QC Criteria

September 1, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8957-CP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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