- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864690
Anxiety Disorders, Depression and Related Factors in PCOS
Prevalence of Anxiety Disorders, Depression and Related Factors in Vietnamese Infertile Women With Polycystic Ovarian Syndrome
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.
Study Overview
Status
Conditions
Detailed 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vu NA Ho, MD
- Phone Number: +84935843336
- Email: bsvu.hna@myduchospital.vn
Study Contact Backup
- Name: Men T Phan, BSc
- Phone Number: +84334646013
- Email: men.pt@myduchospital.vn
Study Locations
-
-
-
Ho Chi Minh City, Vietnam, 70000
- Recruiting
- My Duc Hospital
-
Contact:
- Tuong M Ho, MSc, MD
- Phone Number: +84 90 3633377
- Email: tuongho.ivfmd@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Infertile Vietnamese women
- Reporting PCOS according to Rotterdam 2003
- Agreement to participate in the study
Exclusion Criteria:
- Having a family history of neuropsychiatric disease
- Patients who are deaf, blind, or born dumb
- Patents cannot understand Vietnamese
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prevalence of anxiety disorders
Time Frame: immediately after the interview
|
The prevalence of anxiety disorders using General Anxiety Disorder-7 (GAD-7).
The minimum values is 0 and maximum values is 21.
Using cutoff score 10 with sensitivity 89% and specificity 82% for any anxiety disorder.
Higher GAD-7 scores correlate with disability and functional impairment (in measures such as work productivity and health care utilization.
|
immediately after the interview
|
The prevalence of depression
Time Frame: immediately after the interview
|
The prevalence of depression using Patient Health Questionnaire -9 (PHQ-9).
The minimum values is 0 and maximum values is 27.
PHQ-9 scores ≥10 were found to be 88% sensitive and also 88% specific for detecting major depressive disorder.
Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization.
|
immediately after the interview
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lan N Vuong, PhD, MD, IVFMD and HOPE Research Center, My Duc Hospital
Publications and helpful links
General Publications
- Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256. Erratum In: Hum Reprod. 2019 Feb 1;34(2):388.
- Deswal R, Narwal V, Dang A, Pundir CS. The Prevalence of Polycystic Ovary Syndrome: A Brief Systematic Review. J Hum Reprod Sci. 2020 Oct-Dec;13(4):261-271. doi: 10.4103/jhrs.JHRS_95_18. Epub 2020 Dec 28.
- Anagnostis P, Tarlatzis BC, Kauffman RP. Polycystic ovarian syndrome (PCOS): Long-term metabolic consequences. Metabolism. 2018 Sep;86:33-43. doi: 10.1016/j.metabol.2017.09.016. Epub 2017 Oct 10.
- Brutocao C, Zaiem F, Alsawas M, Morrow AS, Murad MH, Javed A. Psychiatric disorders in women with polycystic ovary syndrome: a systematic review and meta-analysis. Endocrine. 2018 Nov;62(2):318-325. doi: 10.1007/s12020-018-1692-3. Epub 2018 Jul 31.
- Borghi L, Leone D, Vegni E, Galiano V, Lepadatu C, Sulpizio P, Garzia E. Psychological distress, anger and quality of life in polycystic ovary syndrome: associations with biochemical, phenotypical andsocio-demographic factors. J Psychosom Obstet Gynaecol. 2018 Jun;39(2):128-137. doi: 10.1080/0167482X.2017.1311319. Epub 2017 Apr 6.
- Authier M, Normand C, Jego M, Gaborit B, Boubli L, Courbiere B. Qualitative study of self-reported experiences of infertile women with polycystic ovary syndrome through on-line discussion forums. Ann Endocrinol (Paris). 2020 Oct;81(5):487-492. doi: 10.1016/j.ando.2020.07.1110. Epub 2020 Aug 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04/23/DD-BVMD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PCOS
-
University Of PerugiaRecruiting
-
Guangdong Women and Children HospitalRecruiting
-
Khyber Medical University PeshawarCompleted
-
AdventHealth Translational Research InstituteActive, not recruiting
-
Ain Shams Maternity HospitalUnknown
-
Children's Mercy Hospital Kansas CityCompleted
-
Poznan University of Medical SciencesUniversity of California, San DiegoUnknown
-
University of SalernoTheoreo SrlCompleted
-
Genesis Center for Fertility & Human Pre-Implantation...Unknown