The Psychological and Social Impact of PCOS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score
时间窗: 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
次要结局
- 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)