AnxietyNCT01893216
Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men
An observational study of Anxiety and Depression, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Sexual Dysfunction
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Sep 2013
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: male outpatients visiting the Centre of Reproduction at First Affiliated Hospital of Sun Yat-sen University
Who may be able to join
- men who seek treatment for infertility (infertility is defined as the inability to conceive after 1 year of unprotected intercourse)
- age ≥ 18 years
- in a heterosexual, stable relationship for at least 1 year
- able to read and speak Chinese
Who cannot join
- inability to read and understand the questionnaire because of language difficulties
- already evaluated during an earlier survey
- men on medication that could have affected their ejaculatory and erectile function and/or psychological status
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Deng, MD, PhD, +86 20 87332200
Wan, MD
About this study
Official title: Study of Possible Interactions Between Psychiatric Disorders and Sexual Dysfunction in Infertile Men
To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.
Read the detailed description
Although psychological disorders such as anxiety and depression are known to be associated with sexual dysfunction, and their interactions have been reported by many studies, particularly the prevalence of these two aspects and the relationship between them in infertile men in China have not been well investigated.
The investigators' aim is to evaluate the prevalence of psychological symptoms and sexual dysfunction and interactions between them systematically by using validated questionnaires and scales.
- Conditions
- Anxiety, Depression, Sexual Dysfunction, Infertility
- Keywords
- anxiety, depression, sexual dysfunction, infertility
- Medical subject headings
- Anxiety Disorders, Depression, Sexual Dysfunction, Physiological, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with depression or anxiety | Hospital Anxiety and Depression Scale score over 9 points | |
| without depression or anxiety | Hospital Anxiety and Depression Scale score less than 8 points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men
Measured: one year
Secondary outcomes (1)
Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Zi, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Chunhua Deng, MD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893216
- Sponsor's protocol ID
- IMPsySex
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Possible Interactions Between Psychiatric Disorders and Sexual Dysfunction in Infertile Men
- ClinicalTrials.gov ID
- NCT01893216
- Acronym / sponsor ID
- IMPsySex
- Conditions
- Anxiety, Depression, Sexual Dysfunction, Infertility
- Keywords
- anxiety, depression, sexual dysfunction, infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 Jul 2013 (estimated)
- 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.
To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.
Detailed description
Although psychological disorders such as anxiety and depression are known to be associated with sexual dysfunction, and their interactions have been reported by many studies, particularly the prevalence of these two aspects and the relationship between them in infertile men in China have not been well investigated.
The investigators' aim is to evaluate the prevalence of psychological symptoms and sexual dysfunction and interactions between them systematically by using validated questionnaires and scales.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with depression or anxiety | – | –Hospital Anxiety and Depression Scale score over 9 points |
| without depression or anxiety | – | –Hospital Anxiety and Depression Scale score less than 8 points |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- male outpatients visiting the Centre of Reproduction at First Affiliated Hospital of Sun Yat-sen University
Key inclusion criteria (4 listed)
- men who seek treatment for infertility (infertility is defined as the inability to conceive after 1 year of unprotected intercourse)
- age ≥ 18 years
- in a heterosexual, stable relationship for at least 1 year
- able to read and speak Chinese
Key exclusion criteria (3 listed)
- inability to read and understand the questionnaire because of language difficulties
- already evaluated during an earlier survey
- men on medication that could have affected their ejaculatory and erectile function and/or psychological status
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
Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men
Time frame: one year
1 secondary outcome
Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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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.
Chunhua Deng, MD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 Anxiety and Depression, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Jul 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zi Wan, MD (15013063468, zi_wan2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2013.