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Clinical Trials/NCT05982236
NCT05982236
Recruiting
Not Applicable

The Psychological and Social Impact of PCOS

University Hospital, Lille1 site in 1 country100 target enrollmentJuly 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovary Syndrome
Sponsor
University Hospital, Lille
Enrollment
100
Locations
1
Primary Endpoint
Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of the study is to assess the association between the quality of life of patients with PCOS and various factors (age, BMI, socio-professional category, delay in diagnostic of PCOS, infertility, hyperandrogenism, parity, history of anxiety and depression, cycles disorders). This study will be proposed to patients known to have PCOS, during a follow-up consultation or a visit to a day hospital in the Gynaecology Department and/or a consultation in the Reproductive Medicine Department. No-objection forms will be collected at the same time. A link will be sent by e-mail to the patient to access the online questionnaire on the WEPI software and complete it after the consultation. Responses to the questionnaire will be collected progressively and stored in a secure RedCAP file.

Registry
clinicaltrials.gov
Start Date
July 7, 2023
End Date
April 7, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female sex
  • Adult patient (aged 18 or over)
  • Able to read and write in French
  • diagnosed at a previous consultation as having PCOS according to the Rotterdam criteria (at least 2 out of 3 criteria from:
  • Clinical signs of hyperandrogenism (hirsutism, acne, androgenic alopecia) and/or biochemical signs of hyperandrogenism (total testosterone \> 0.39 ng/mL and/or androstenedione \> 1.75 ng/mL)
  • Ovulation disorders (infertility, oligomenorrhoea or amenorrhoea or cycle length either \<21 days or \>35 days),
  • Polymicrocystic ovaries on ultrasound (either 19 or more follicles measuring 2-9 mm in diameter and/or increased ovarian volume (\>10 cm3) and/or increased ovarian area (\> 5.5 cm²) without presence of cyst or dominant follicle.)
  • Informed consent

Exclusion Criteria

  • Patient with no health insurance cover
  • Difficulties understanding or speaking French
  • Computer (tablet/smartphone) and internet connection required.
  • Refusal to take part in research
  • Under court protection (guardianship/curatorship/privation of liberty)

Outcomes

Primary Outcomes

Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score

Time Frame: Day of inclusion

according to predefined factors (age, BMI, socio-professional category, delay in diagnosis of Polycystic Ovary Syndrome, infertility, hyperandrogenism, parity, history of anxiety and depression, cycle disorders). Mininum score: 35, maximum score: 245, A higher score means best result

Secondary Outcomes

  • Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors(Day of inclusion)
  • Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors(Day of inclusion)
  • Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors(Day of inclusion)

Study Sites (1)

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