History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome

Sponsor
CHU de Reims (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04998448
Collaborator
(none)
200
1
12
16.7

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome is a common endocrine disorder that affects between 7% and 14% of women of childbearing age, leading to impaired fertility, clinical and biological hyperandrogenism.

Long-term complications such as metabolic disorders, cardiovascular disease and hormone-dependent cancers make it a major public health problem.

The physiopathology of this syndrome is complicated and still poorly understood, probably multifactorial origin, resulting from the interaction between many factors (genetics, lifestyle, environment).

The environment has also an important role in the development of polycystic ovary syndrome :

diet, exposure to pollutants and endocrine disruptors.

There are many sources of exposure to environmental toxins and it is essential to better understand their impact on our health.

Our study aims to assess the association between exposure to endocrine disruptors and development of polycystic ovary syndrome.

The population involved in the study includes patients aged 18 to 50 years, premenopausal, consulting in the gynecology department of the university hospital of Reims.

The "cases" patients will be patients with polycystic ovary syndrome. The "controls" patients will be patients without polycystic ovary syndrome. Statistical analysis will determine whether "cases" are more exposed to endocrine disruptors than "controls".

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Polycystic ovary syndrome is a common endocrine disorder that affects between 7% and 14% of women of childbearing age, leading to impaired fertility, clinical and biological hyperandrogenism.

    Long-term complications such as metabolic disorders, cardiovascular disease and hormone-dependent cancers make it a major public health problem.

    The physiopathology of this syndrome is complicated and still poorly understood, probably multifactorial origin, resulting from the interaction between many factors (genetics, lifestyle, environment).

    The environment has also an important role in the development of polycystic ovary syndrome :

    diet, exposure to pollutants and endocrine disruptors.

    There are many sources of exposure to environmental toxins and it is essential to better understand their impact on our health.

    Our study aims to assess the association between exposure to endocrine disruptors and development of polycystic ovary syndrome.

    The population involved in the study includes patients aged 18 to 50 years, premenopausal, consulting in the gynecology department of the university hospital of Reims.

    The "cases" patients will be patients with polycystic ovary syndrome. The "controls" patients will be patients without polycystic ovary syndrome. Statistical analysis will determine wether "cases" are more exposed to endocrine disruptors than "controls". "Cases" and "controls" will be matched on age (+/- 5 years).

    The statistical analysis consists of description of data (mean and standard deviation, number and percentage) and comparison of exposure to toxicants and endocrine disruptors according to the "cases" and "controls" group by univariate analysis (tests of Student, Wilcoxon, Chi 2 or Fisher's exact) then multivariate (logistic regression).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome
    Anticipated Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Cases

    women aged 18 to 50 years, premenopausal, with polycystic ovary syndrome

    Controls

    women aged 18 to 50 years, premenopausal, without polycystic ovary syndrome.

    Outcome Measures

    Primary Outcome Measures

    1. Survey form on exposure to endocrine disruptors [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    inclusion criteria for "cases" :

    • age 18 to 50 years

    • premenopausal

    • diagnostic of PCOS has been made according to Rotterdam criteria

    • followed in the gynecology and endocrinology departments at the university hospital of Reims.

    • agreeing to participate in the study

    inclusion criteria for "controls"

    • age 18 to 50 years

    • premenopausal

    • diagnostic of PCOS can be excluded du to the absence of menstrual cycle disorders and absence of clinical signs of hyperandrogenism

    • followed in the gynecology and endocrinology departments at the university hospital of Reims.

    • agreeing to participate in the study

    exclusion criteria:

    • under the of 18 years or over 50 years

    • menopausal

    • refusing to participate in the study

    • protected by law

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damien JOLLY Reims France

    Sponsors and Collaborators

    • CHU de Reims

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CHU de Reims
    ClinicalTrials.gov Identifier:
    NCT04998448
    Other Study ID Numbers:
    • PO21065
    First Posted:
    Aug 10, 2021
    Last Update Posted:
    Aug 10, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CHU de Reims
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2021