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Translation and Validation of the French mPCOSQ (mPCOSQ-F).

Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07016035
Enrollment
350
Registered
2025-06-11
Start date
2025-05-12
Completion date
2027-05-12
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome Health-related Quality of Life

Keywords

polycystic ovary syndrome, PCOS, quality of life, health-related quality of life, mPCOSQ, questionnaire, SF-36, French

Brief 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. 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.

Interventions

OTHERmPCOSQ-F and SF-36

Questionnaires

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder * Pregnancy or breast-feeding * Under legal protection

Design outcomes

Primary

MeasureTime frame
Content validity of mPCOSQ as determined by the experts groupAt 2 years
Feasibility of mPCOSQAt 2 years
Acceptability of mPCOSQAt 2 years
Structure validity of mPCOSQAt 2 years
Reproductibility of mPCOSQAt 2 years
Reliabilty of mPCOSQAt 2 years
Total mPCSOQ scoreAt 15 days
SF-36 scoresAt 1 day
Scores in the weight domain based on BMIAt 1 day
Scores in the fertility domain based on the need for reproductive medicine or parenthoodAt 1 day
Scores in the hirsutism domain based on the Ferriman-Gallwey scoreAt 1 day

Countries

France

Contacts

Primary ContactSara BARRAUD
sbarraud@chu-reims.fr03 10 73 63 82
Backup ContactCamille TETU
ctetu@chu-reims.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026