The Psychological and Social Impact of PCOS

Recruiting

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT05982236
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Status Verified: 2023-08
• Study First Posted: 2023-08-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25
• Primary Completion: 2024-04-07
• Study Completion: 2024-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score	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 Outcome Measures

Name	Time	Method
Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors	Day of inclusion	minimun: 0 maximum: 28 A higher score means worse result
Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors	Day of inclusion	minimun: 0 maximum: 42. A higher score means worse result
Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors	Day of inclusion	minimun: 0 maximum: 30. A higher score means better result

Trial Locations

Locations (1)

CHU de Lille Hôpital Jeanne de Flandre; 🇫🇷 Lille, Nord, France