NCT00046124

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2002

Completed
Last Updated

September 4, 2006

Status Verified

September 1, 2006

First QC Date

September 20, 2002

Last Update Submit

September 1, 2006

Conditions

FecundabilitySpermatazoa DisordersMenstruation DisordersEndocrine Dysfunction

Eligibility Criteria

Age20 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Anqing, Anhui, China

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 2002

First Posted

September 23, 2002

Last Updated

September 4, 2006

Record last verified: 2006-09

Locations

CN(1)