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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01893216
Other study ID # IMPsySex
Secondary ID
Status Recruiting
Phase N/A
First received July 2, 2013
Last updated July 5, 2013
Start date April 2013
Est. completion date September 2013

Study information

Verified date July 2013
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Zi Wan, MD
Phone 15013063468
Email zi_wan2012@163.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
China The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men one year No
Secondary Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men one year No
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