Polycystic Ovary Syndrome Health-related Quality of LifeNCT07016035
Translation and Validation of the French mPCOSQ (mPCOSQ-F).
An observational study of Polycystic Ovary Syndrome Health-related Quality of Life, run by CHU de Reims at 1 site in France.
Trial summary
This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome Health-related Quality of Life
- What is being tested?
- mPCOSQ-F and SF-36
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2025to 12 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients were PCOS women recruited from the Reims University Hospital and the Charleville-Mézières Hospital when presenting to endocrinology, gynaecology or reproductive medicine consults.
Who may be able to join
- Women aged 18 to 45
- Fluent in french
- Having a diagnosis of PCOS according to the international recommendations published in 2023
- Willing to participate in the study
- Affiliated to the french social security system
Who cannot join
- Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder
- Pregnancy or breast-feeding
- Under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Camille TETU contact
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Sara BARRAUD, 03 10 73 63 82 ext. 0033, sbarraud@chu-reims.fr
Camille TETU, ctetu@chu-reims.fr
About this study
Official title: Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.
This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
Read the detailed description
The aim of this study is to assess the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
Women aged 18 to 45 years with a diagnosis of polycystic ovary syndrome will be included.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
The pre-test phase purpose is to appraise the face validity and feasibility of the questionnaire through phone interviews with the thirty first respondents.
In the final phase, we aimed to evaluate the validity and reliability of the mPCOSQ, and to compare it to the SF-36.
- Being tested
- mPCOSQ-F and SF-36
- Keywords
- polycystic ovary syndrome, PCOS, quality of life, health-related quality of life, mPCOSQ, questionnaire, SF-36, French
- 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.
mPCOSQ-F and SF-36Other
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Polycystic ovary syndrome | patients with Polycystic ovary syndrome Receives: Other: mPCOSQ-F and SF-36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content validity of mPCOSQ as determined by the experts group
Measured: At 2 years
Feasibility of mPCOSQ
Measured: At 2 years
Acceptability of mPCOSQ
Measured: At 2 years
Structure validity of mPCOSQ
Measured: At 2 years
Reproductibility of mPCOSQ
Measured: At 2 years
Reliabilty of mPCOSQ
Measured: At 2 years
Total mPCSOQ score
Measured: At 15 days
SF-36 scores
Measured: At 1 day
Scores in the " weight " domain based on BMI
Measured: At 1 day
Scores in the " fertility " domain based on the need for reproductive medicine or parenthood
Measured: At 1 day
Scores in the " hirsutism " domain based on the Ferriman-Gallwey score
Measured: At 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start12 May 2025
- Primary completion12 May 2027 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome Health-related Quality of LifeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 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
- NCT07016035
- Sponsor's protocol ID
- PS25052
- Status last verified
- Aug 2025
- First submitted
- 13 May 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.
- ClinicalTrials.gov ID
- NCT07016035
- Acronym / sponsor ID
- PS25052
- Keywords
- polycystic ovary syndrome, PCOS, quality of life, health-related quality of life, mPCOSQ, questionnaire, SF-36, French
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
Detailed description
The aim of this study is to assess the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
Women aged 18 to 45 years with a diagnosis of polycystic ovary syndrome will be included.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
The pre-test phase purpose is to appraise the face validity and feasibility of the questionnaire through phone interviews with the thirty first respondents.
In the final phase, we aimed to evaluate the validity and reliability of the mPCOSQ, and to compare it to the SF-36.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polycystic ovary syndrome | – | Other: mPCOSQ-F and SF-36patients with Polycystic ovary syndrome |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients were PCOS women recruited from the Reims University Hospital and the Charleville-Mézières Hospital when presenting to endocrinology, gynaecology or reproductive medicine consults.
Key inclusion criteria (5 listed)
- Women aged 18 to 45
- Fluent in french
- Having a diagnosis of PCOS according to the international recommendations published in 2023
- Willing to participate in the study
- Affiliated to the french social security system
Key exclusion criteria (3 listed)
- Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder
- Pregnancy or breast-feeding
- Under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mPCOSQ-F and SF-36Questionnaires | Other | Polycystic ovary syndrome |
Primary outcome
Content validity of mPCOSQ as determined by the experts group
Time frame: At 2 years
Feasibility of mPCOSQ
Time frame: At 2 years
Acceptability of mPCOSQ
Time frame: At 2 years
Structure validity of mPCOSQ
Time frame: At 2 years
Reproductibility of mPCOSQ
Time frame: At 2 years
Reliabilty of mPCOSQ
Time frame: At 2 years
Total mPCSOQ score
Time frame: At 15 days
SF-36 scores
Time frame: At 1 day
Scores in the " weight " domain based on BMI
Time frame: At 1 day
Scores in the " fertility " domain based on the need for reproductive medicine or parenthood
Time frame: At 1 day
Scores in the " hirsutism " domain based on the Ferriman-Gallwey score
Time frame: At 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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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.
Camille TETU contact
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 Health-related Quality of Life, 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara BARRAUD (03 10 73 63 82 ext. 0033, sbarraud@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content validity of mPCOSQ as determined by the experts group (time frame: At 2 years). The study lists 11 primary outcomes in all. 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 7 Aug 2025.