Clinical Trials Directory

Trials / Completed

CompletedNCT02802397

AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
335 (actual)
Sponsor
Rennes University Hospital · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

Summary

Early ovarian reserve decreased is one of the main causes of infertility for women after 35 years. The relationship between this decreased and exposure to chemicals, including persistent endocrine disruptors or organic solvents, has been little studied. However, several in vivo or in vitro experimental studies suggested that these chemicals may impaired ovarian function. The main objective is to study the relationship between early ovarian reserve decreased and exposure to persistent organic pollutants. The secondary objectives are to study the relationship between early ovarian reserve decreased and exposure to organic solvents and heavy metals. Multicenter case-control study. This project will permit to increase the knowledge concerning the etiology of early decreased ovarian reserve. Considering that exposure of interest are frequent, the results may be important in a public health perspective. If associations are observed in this study, the results may encouraged prevention strategy.

Detailed description

Cases and controls will benefit, as usual in France concerning infertility etiology examinations, of a follicle antral count by transvaginal ultrasound and AMH measurement. At baseline, physicians will complete a short questionnaire to check the inclusion criterion, the results of the measurement of follicle count and hormone measurement (including AMH). Cases and controls will respond to self-administered questionnaire at inclusion with information about their medical history, their demographics, their tobacco and alcohol consumption, their occupation and products handled in the workplace. Blood samples (for measure of persistent organic pollutants and heavy metals) and urine (for measure of metabolites of glycol ethers) will be collect at baseline. Occupational exposures to solvents will be defined using job exposures matrices. The risk of decreased ovarian reserve will be analyzed using logistic regressions for each exposure of interest adjusting for potential confounders.

Conditions

Interventions

TypeNameDescription
OTHERSelf-administered questionnaire and blood and urine samplesSelf-administered questionnaire and blood and urine samples

Timeline

Start date
2016-12-06
Primary completion
2020-02-06
Completion
2020-11-02
First posted
2016-06-16
Last updated
2023-05-23

Locations

5 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02802397. Inclusion in this directory is not an endorsement.