- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998448
History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome
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".
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anne FEVRE
- Phone Number: 0033 03 26 83 27 48
- Email: afevre@chu-reims.fr
Study Locations
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Reims, France
- Damien JOLLY
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Contact:
- Anne FEVRE
- Phone Number: 0033 03 26 83 27 48
- Email: afevre@chu-reims.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cases
women aged 18 to 50 years, premenopausal, with polycystic ovary syndrome
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Controls
women aged 18 to 50 years, premenopausal, without polycystic ovary syndrome.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Survey form on exposure to endocrine disruptors
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO21065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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