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SPICE: The Psychological and Social Impact of PCOS

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT05982236
Collaborator
(none)
100
Enrollment
1
Location
9
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Psychological and Social Impact of PCOS
Actual Study Start Date :
Jul 7, 2023
Anticipated Primary Completion Date :
Apr 7, 2024
Anticipated Study Completion Date :
Apr 7, 2024

Arms and Interventions

Arm Intervention/Treatment
PCOS patients

Other: Questionnaire
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.
Other Names:
  • Questionnaire on WEPI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score [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).

    Secondary Outcome Measures

    1. Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors [Day of inclusion]

      minimun: 0 maximum: 42. A higher score means worse result

    2. Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors [Day of inclusion]

      minimun: 0 maximum: 28 A higher score means worse result

    3. Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors [Day of inclusion]

      minimun: 0 maximum: 30. A higher score means better result

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Lille Hôpital Jeanne de Flandre Lille Nord France 59000

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05982236
    Other Study ID Numbers:
    • 2022_0685
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome

    Study Results

    No Results Posted as of Aug 14, 2023