Translation and Validation of the French mPCOSQ (mPCOSQ-F).
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorCHU de Reims
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder
Pregnancy or breast-feeding
Under legal protection
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
mPCOSQ-F and SF-36
Other interventionQuestionnaires
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Polycystic ovary syndrome1 intervention
Trial outcomes
Primary outcomes
1
Content validity of mPCOSQ as determined by the experts group
Time frame
At 2 years2
Feasibility of mPCOSQ
Time frame
At 2 years3
Acceptability of mPCOSQ
Time frame
At 2 years4
Structure validity of mPCOSQ
Time frame
At 2 yearsSponsors and contacts
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Source ClinicalTrials.gov