History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome
NCT ID: NCT04998448
Last Updated: 2021-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-10-31
2022-10-31
Brief Summary
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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".
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cases
women aged 18 to 50 years, premenopausal, with polycystic ovary syndrome
No interventions assigned to this group
Controls
women aged 18 to 50 years, premenopausal, without polycystic ovary syndrome.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* menopausal
* refusing to participate in the study
* protected by law
18 Years
50 Years
FEMALE
Yes
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Damien JOLLY
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PO21065
Identifier Type: -
Identifier Source: org_study_id
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