The Psychological and Social Impact of PCOS

Polycystic Ovary Syndrome Clinical Trial

— SPICE  

Official title:

The Psychological and Social Impact of PCOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982236
• Other study ID #: 2022_0685
• Status: Recruiting
• Start date: July 7, 2023
• Est. completion date: April 7, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Lille
• Contact: Aramatoulaye Sambou
• Phone: 0033 320444145
• Email: drc[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 7, 2024
• Est. primary completion date: April 7, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Lille Hôpital Jeanne de Flandre	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors	minimun: 0 maximum: 42. A higher score means worse result	Day of inclusion
Secondary	Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors	minimun: 0 maximum: 28 A higher score means worse result	Day of inclusion
Secondary	Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors	minimun: 0 maximum: 30. A higher score means better result	Day of inclusion