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NCT Number: NCT07016035

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Health-related Quality of Life Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mPCOSQ-F and SF-36

Other

Questionnaires

Primary outcomes

  1. Content validity of mPCOSQ as determined by the experts group

    Time frame: At 2 years

  2. Feasibility of mPCOSQ

    Time frame: At 2 years

  3. Acceptability of mPCOSQ

    Time frame: At 2 years

  4. Structure validity of mPCOSQ

    Time frame: At 2 years

  5. Reproductibility of mPCOSQ

    Time frame: At 2 years

  6. Reliabilty of mPCOSQ

    Time frame: At 2 years

  7. Total mPCSOQ score

    Time frame: At 15 days

  8. SF-36 scores

    Time frame: At 1 day

  9. Scores in the " weight " domain based on BMI

    Time frame: At 1 day

  10. Scores in the " fertility " domain based on the need for reproductive medicine or parenthood

    Time frame: At 1 day

  11. Scores in the " hirsutism " domain based on the Ferriman-Gallwey score

    Time frame: At 1 day

Study contacts

Contact information is provided by the study sponsor or research team.

Camille TETU

CONTACT

[email protected]

Sara BARRAUD

CONTACT

[email protected]

03 10 73 63 82 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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