The Psychological and Social Impact of PCOS (NCT05982236) | Clinical Trial Compass
CompletedNot Applicable
The Psychological and Social Impact of PCOS
France100 participantsStarted 2023-07-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score