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Completed

NCT Number: NCT00046124

Organophosphate Pesticides and Human Reproductive Health

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.

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Key information

Conditions

Fecundability Endocrine Dysfunction Menstruation Disorders Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Spermatazoa Disorders

Age range

20 year–34 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Medical University

Anqing, Anhui, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS)

Nih

Registry information

Important dates

First posted
Sep 23, 2002
Registry last updated
Sep 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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