PCOSNCT05864690
Anxiety Disorders, Depression and Related Factors in PCOS
An observational study of PCOS, run by Mỹ Đức Hospital at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PCOS
- How many people
- 768 participants
- Where
- 1 siteVietnam
- Study dates
- 8 May 2023to 29 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Infertile Vietnamese women with PCOS
Who may be able to join
- Infertile Vietnamese women
- Reporting PCOS according to Rotterdam 2003
- Agreement to participate in the study
Who cannot join
- Having a family history of neuropsychiatric disease
- Patients who are deaf, blind, or born dumb
- Patents cannot understand Vietnamese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- PCOS
- Keywords
- infertile women, PCOS, Anxiety disorders, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately after the interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start8 May 2023
- Primary completion29 Mar 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, PhD, MD, Principal investigator, IVFMD and HOPE Research Center, My Duc Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864690
- Sponsor's protocol ID
- 04/23/DD-BVMD
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33627974Anagnostis 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.
PubMed 29024702Teede 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.
PubMed 30052961Brutocao 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.
PubMed 30066285Borghi 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.
PubMed 28385114Authier 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.
PubMed 32827451
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anxiety Disorders, Depression and Related Factors in Vietnamese Infertile Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT05864690
- Acronym / sponsor ID
- 04/23/DD-BVMD
- Conditions
- PCOS
- Keywords
- infertile women, PCOS, Anxiety disorders, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Infertile Vietnamese women with PCOS
Key inclusion criteria (3 listed)
- Infertile Vietnamese women
- Reporting PCOS according to Rotterdam 2003
- Agreement to participate in the study
Key exclusion criteria (3 listed)
- Having a family history of neuropsychiatric disease
- Patients who are deaf, blind, or born dumb
- Patents cannot understand Vietnamese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 33627974Deswal 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.
- Background: PubMed 29024702Anagnostis 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.
- Background: PubMed 30052961Teede 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.
- Background: PubMed 30066285Brutocao 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.
- Background: PubMed 28385114Borghi 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.
- Background: PubMed 32827451Authier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan N Vuong, PhD, MD principal investigator
IVFMD and HOPE Research Center, My Duc Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of anxiety disorders (time frame: immediately after the interview). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05864690, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.