Clinical trial NCT05982236: The Psychological and Social Impact of PCOS
Official title: The Psychological and Social Impact of PCOS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with PCOS

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.


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)

Primary outcomes:
measure: Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score
timeFrame: Day of inclusion
Secondary outcomes:
measure: Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors
timeFrame: Day of inclusion
measure: Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors
timeFrame: Day of inclusion
measure: Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors
timeFrame: Day of inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille Hôpital Jeanne de Flandre
state: Nord
Study officials:
References: