Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-01 @ 10:01 AM
Study NCT ID:
NCT07016035
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Validation of the French mPCOSQ (mPCOSQ-F).
Sponsor:
CHU de Reims
Organization:
Study Overview
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.
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: