The Psychological and Social Impact of PCOS

NCT05982236 | Completed

• 1 other identifier: 2022_0685
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

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

  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

  Day of inclusion

Secondary Outcomes (3)

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

  Day of inclusion

• Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors

  Day of inclusion

• Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors

  Day of inclusion

Study Arms (1)

PCOS patients

Other: Questionnaire

Interventions

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.

Also known as: Questionnaire on WEPI

PCOS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with PCOS

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU de Lille Hôpital Jeanne de Flandre

Lille, Nord, 59000, France

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: July 4, 2023
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)