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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04998448
• Other study ID #: PO21065
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: October 2022

Study information

• Verified date: August 2021
• Source: CHU de Reims
• Contact: Anne FEVRE
• Phone: 03 26 83 27 48
• Email: afevre[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survey form on exposure to endocrine disruptors		1 year