Skip to content

The Psychological and Social Impact of PCOS

The Psychological and Social Impact of PCOS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05982236
Acronym
SPICE
Enrollment
100
Registered
2023-08-08
Start date
2023-07-04
Completion date
2023-12-26
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

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.

Interventions

OTHERQuestionnaire

Questionnaire on WEPI software (secure data), with link sent by e-mail to patients included in the study, including PCOSQOL, HADS, FACT G7 et ASEX scores.

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire scoreDay of inclusionaccording 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

MeasureTime frameDescription
Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factorsDay of inclusionminimun: 0 maximum: 42. A higher score means worse result
Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factorsDay of inclusionminimun: 0 maximum: 28 A higher score means worse result
Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factorsDay of inclusionminimun: 0 maximum: 30. A higher score means better result

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026