ClinicalTrials.Veeva

Menu

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

C

CHU de Reims

Status

Unknown

Conditions

Polycystic Ovary Syndrome
Exposure to Endocrine Disruptors

Study type

Observational

Funder types

Other

Identifiers

NCT04998448
PO21065

Details and patient eligibility

About

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".

Full 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).

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

200 participants in 2 patient groups

Cases
Description:
women aged 18 to 50 years, premenopausal, with polycystic ovary syndrome
Controls
Description:
women aged 18 to 50 years, premenopausal, without polycystic ovary syndrome.

Trial contacts and locations

1

Loading...

Central trial contact

Anne FEVRE

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems