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

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome Health-related Quality of Life

• Registration Number: NCT07016035
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Content validity of mPCOSQ as determined by the experts group	At 2 years
Feasibility of mPCOSQ	At 2 years
Acceptability of mPCOSQ	At 2 years
Structure validity of mPCOSQ	At 2 years
Reproductibility of mPCOSQ	At 2 years
Reliabilty of mPCOSQ	At 2 years
Total mPCSOQ score	At 15 days
SF-36 scores	At 1 day
Scores in the " weight " domain based on BMI	At 1 day
Scores in the " fertility " domain based on the need for reproductive medicine or parenthood	At 1 day
Scores in the " hirsutism " domain based on the Ferriman-Gallwey score	At 1 day

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France