Clinical trial NCT07016035: Translation and Validation of the French mPCOSQ (mPCOSQ-F).
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Content validity of mPCOSQ as determined by the experts group
timeFrame: At 2 years
measure: Feasibility of mPCOSQ
timeFrame: At 2 years
measure: Acceptability of mPCOSQ
timeFrame: At 2 years
measure: Structure validity of mPCOSQ
timeFrame: At 2 years
measure: Reproductibility of mPCOSQ
timeFrame: At 2 years
measure: Reliabilty of mPCOSQ
timeFrame: At 2 years
measure: Total mPCSOQ score
timeFrame: At 15 days
measure: SF-36 scores
timeFrame: At 1 day
measure: Scores in the " weight " domain based on BMI
timeFrame: At 1 day
measure: Scores in the " fertility " domain based on the need for reproductive medicine or parenthood
timeFrame: At 1 day
measure: Scores in the " hirsutism " domain based on the Ferriman-Gallwey score
timeFrame: At 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: