Anxiety Disorders, Depression and Related Factors in PCOS

NCT05864690 | Completed

• 1 other identifier: 04/23/DD-BVMD
• Study Type: observational
• Target: 768
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS

Keywords

infertile women; PCOS; Anxiety disorders; Depression

Outcome Measures

Primary Outcomes (2)

• The prevalence of anxiety disorders

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infertile Vietnamese women with PCOS

You may qualify if:

• Infertile Vietnamese women
• Reporting PCOS according to Rotterdam 2003
• Agreement to participate in the study

You may not qualify if:

• Having a family history of neuropsychiatric disease
• Patients who are deaf, blind, or born dumb
• Patents cannot understand Vietnamese

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (6)

• 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.

  PMID: 33627974 BACKGROUND

• 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.

  PMID: 29024702 BACKGROUND

• 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.

  PMID: 30052961 BACKGROUND

• 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.

  PMID: 30066285 BACKGROUND

• 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.

  PMID: 28385114 BACKGROUND

• 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.

  PMID: 32827451 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lan N Vuong, PhD, MD

  IVFMD and HOPE Research Center, My Duc Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 18, 2023
• Study Start: May 8, 2023
• Primary Completion: March 29, 2025
• Study Completion: March 29, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

VN (1)