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Trial Title:
The Psychological and Social Impact of PCOS
NCT ID:
NCT05982236
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Questionnaire
Description:
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.
Arm group label:
PCOS patients
Other name:
Questionnaire on WEPI
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.
Criteria for eligibility:
Study pop:
Patient with PCOS
Sampling method:
Non-Probability Sample
Criteria:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Lille Hôpital Jeanne de Flandre
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Contact:
Last name:
Sophie Catteau-Jonard, MD
Investigator:
Last name:
Sophie Catteau-Jonard, md
Email:
Principal Investigator
Start date:
July 7, 2023
Completion date:
April 7, 2024
Lead sponsor:
Agency:
University Hospital, Lille
Agency class:
Other
Source:
University Hospital, Lille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982236
