Clinical trial NCT05864690: Anxiety Disorders, Depression and Related Factors in PCOS
Official title: Prevalence of Anxiety Disorders, Depression and Related Factors in Vietnamese Infertile Women With Polycystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PCOS
Keywords: infertile women
PCOS
Anxiety disorders
Depression
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 768
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile Vietnamese women with PCOS

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of anxiety disorders
timeFrame: immediately after the interview
measure: The prevalence of depression
timeFrame: immediately after the interview
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: IVFMD and HOPE Research Center, My Duc Hospital
name: Lan N Vuong, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.