Clinical trial · Observational
The Psychological and Social Impact of PCOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PCOS patients
- interventionNames
- Other: Questionnaire
Primary outcomes (1)
- measure
- Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score
- timeFrame
- Day of inclusion
- description
- 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 (3)
- measure
- Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors
- timeFrame
- Day of inclusion
- description
- minimun: 0 maximum: 42. A higher score means worse result
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available