The Psychological and Social Impact of PCOS

NCT ID: NCT05982236

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-07

Study Completion Date

2024-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PCOS patients

Questionnaire

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Questionnaire on WEPI

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Lille Hôpital Jeanne de Flandre

Lille, Nord, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aramatoulaye Sambou

Role: CONTACT

0033 320444145

Facility Contacts

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Sophie Catteau-Jonard, MD

Role: primary

Other Identifiers

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2022_0685

Identifier Type: -

Identifier Source: org_study_id

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