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

CHU de Reims

Status: Enrolling

Conditions: Polycystic Ovary Syndrome Health-related Quality of Life

Treatments: Other: mPCOSQ-F and SF-36

Study type: Observational

Funder types: Other

Identifiers

NCT07016035

PS25052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 1 patient group

Polycystic ovary syndrome

Description:

patients with Polycystic ovary syndrome

Treatment:

Other: mPCOSQ-F and SF-36