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Completed

NCT Number: NCT05982236

The Psychological and Social Impact of PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Lille Hôpital Jeanne de Flandre

Lille, Nord, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

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

    Time frame: 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). Mininum score: 35, maximum score: 245, A higher score means best result

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Day of inclusion

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: SPICE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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