Polycystic Ovary SyndromeNCT04998448
History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Exposure to Endocrine Disruptors, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Exposure to Endocrine Disruptors
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2021to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
- age 18 to 50 years
Show all 10Show fewer
- 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
Who cannot join
- under the of 18 years or over 50 years
- menopausal
- refusing to participate in the study
- protected by law
Trial locations and contacts
1 site in 1 country.
France1 site
Damien JOLLY
Reims
Anne FEVRE, 03 26 83 27 48 ext. 0033, afevre@chu-reims.fr
About this study
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.
Read more
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".
Read the 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).
- Keywords
- Polycystic ovary syndrome, Endocrine disruptors
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Survey form on exposure to endocrine disruptors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998448
- Sponsor's protocol ID
- PO21065
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04998448
- Acronym / sponsor ID
- PO21065
- Keywords
- Polycystic ovary syndrome, Endocrine disruptors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –women aged 18 to 50 years, premenopausal, with polycystic ovary syndrome |
| Controls | – | –women aged 18 to 50 years, premenopausal, without polycystic ovary syndrome. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- under the of 18 years or over 50 years
- menopausal
- refusing to participate in the study
- protected by law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey form on exposure to endocrine disruptors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Exposure to Endocrine Disruptors, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne FEVRE (03 26 83 27 48 ext. 0033, afevre@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey form on exposure to endocrine disruptors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.