Organophosphate Pesticides and Human Reproductive Health - Tabular View

Tracking Information
First Received Date ^ICMJE	September 20, 2002
Last Updated Date	September 1, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00046124 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Organophosphate Pesticides and Human Reproductive Health
Official Title ^ICMJE
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Natural History, Longitudinal, Defined Population, Prospective Study
Condition ^ICMJE	Fecundability Spermatazoa Disorders Menstruation Disorders Endocrine Dysfunction
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years to 34 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT ID ^ICMJE	NCT00046124
Responsible Party
Study ID Numbers ^ICMJE	8957-CP-001
Study Sponsor ^ICMJE	National Institute of Environmental Health Sciences (NIEHS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Environmental Health Sciences (NIEHS)
Verification Date	September 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP