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Clinical Trials in France / NCT07016035
Recruiting Observational

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

NCT07016035 · tracked via the Priya Life Science France tracker
Sponsor
CHU de Reims
Phase
Observational
Started
2025-05-12
Last updated
2025-08-07

Condition(s) studied

Polycystic Ovary Syndrome Health-related Quality of Life

Investigational drug(s) / intervention(s)

mPCOSQ-F and SF-36

mPCOSQ-F and SF-36: Questionnaires

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Damien JOLLY Reims France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07016035 on ClinicalTrials.gov ↗ ← All trials in France