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

August 9, 2021 updated by: CHU de Reims

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

Not yet recruiting

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

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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. "Cases" and "controls" will be matched on age (+/- 5 years).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
women aged 18 to 50 years, premenopausal, with polycystic ovary syndrome
Controls
women aged 18 to 50 years, premenopausal, without polycystic ovary syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survey form on exposure to endocrine disruptors
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (ACTUAL)

August 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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