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The Psychological and Social Impact of PCOS (SPICE)

U

University Hospital, Lille

Status

Enrolling

Conditions

Polycystic Ovary Syndrome

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT05982236
2022_0685

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

PCOS patients
Treatment:
Other: Questionnaire

Trial contacts and locations

1

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Central trial contact

Aramatoulaye Sambou

Data sourced from clinicaltrials.gov

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