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

NCT ID: NCT07016035

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-05-12

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Health-related Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Polycystic ovary syndrome

patients with Polycystic ovary syndrome

mPCOSQ-F and SF-36

Intervention Type OTHER

Questionnaires

Interventions

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mPCOSQ-F and SF-36

Questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sara BARRAUD

Role: CONTACT

03 10 73 63 82 ext. 0033

Camille TETU

Role: CONTACT

Facility Contacts

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Sara BARRAUD

Role: primary

03 10 73 63 82 ext. 0033

Camille TETU

Role: backup

Other Identifiers

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PS25052

Identifier Type: -

Identifier Source: org_study_id

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