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Clinical Trial Summary

Polycystic ovary syndrome (PCOS) is a systemic neuro-endocrine-metabolic-reproductive disorder, common in women of reproductive age, affecting 21.27% of women worldwide and the rate of PCOS has been increasing over the past decade. Women with PCOS have many health problems, including insulin resistance, hyperandrogenemia, and ovulation disorders. Moreover, PCOS is also associated with significant consequences such as increased risk of cardiovascular disease, glucose intolerance and diabetes mellitus (both type 2 and gestational), increased risk of endometrial hyperplasia and endometrial cancer and mental health disorders. A meta-analysis of 57 studies has been reported that women with PCOS are more likely to have an increased risk of diagnosis of depression, anxiety, bipolar disorder, and obsessive-compulsive disorder. These psychological disorders may be related to biometric and biochemical characteristics in women with PCOS, such as body image, hirsutism or acne. Furthermore, researches showed that waist-to-hip ratio and plasmatic levels of testosterone is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress. Psychological consequences may also be related to other factors, including stigmatization and isolation, the lack of empathy from family and friends, the feeling of guilt and the diminished sense of self-worth, the costs of treatment and treatment outcomes. However, there has been no data on the psychological disorders in infertile women with PCOS. Therefore, the study aimed to determine the prevalence of anxiety disorders, depression in infertile women with PCOS and associated factors.


Clinical Trial Description

- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam. - Women who are potentially eligible will be provided information about the study purposes, procedures, related risk and benefits - Screening for eligibility will be performed on the day of the first visit when diagnosis about PCOS is established. - Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment. - All patients selected for this study will answer the questionares and complete the GAD-7 GAD-7 (General Anxiety Disorder-7) and PHQ-9 (Patient Health Questionnaire-9) following careful instruction on how to complete the instrument by investigator in a private room without the presence of their husband. - The survey will last about 15 minutes. If the result of the GAD-7 and PHQ-9 suggested anxiety disorders, depression, the patient will refer to specialists for further assessment and treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05864690
Study type Observational
Source M? Ð?c Hospital
Contact Men T Phan, BSc
Phone +84334646013
Email men.pt@myduchospital.vn
Status Recruiting
Phase
Start date May 8, 2023
Completion date February 28, 2025

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