Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Wan Zi, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01893216
First received: July 2, 2013
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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


Condition
Anxiety
Depression
Sexual Dysfunction
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Possible Interactions Between Psychiatric Disorders and Sexual Dysfunction in Infertile Men

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: April 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

male outpatients visiting the Centre of Reproduction at First Affiliated Hospital of Sun Yat-sen University

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893216

Contacts
Contact: Zi Wan, MD 15013063468 zi_wan2012@163.com

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Deng, MD, PhD    +86 20 87332200      
Principal Investigator: Wan, MD         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Chunhua Deng, MD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Wan Zi, Doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01893216     History of Changes
Other Study ID Numbers: IMPsySex
Study First Received: July 2, 2013
Last Updated: July 5, 2013
Health Authority: China: Ministry of Health

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
anxiety
depression
sexual dysfunction
infertility

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Anxiety Disorders
Mental Disorders
Depression
Depressive Disorder
Infertility
Behavioral Symptoms
Mood Disorders
Genital Diseases, Male
Genital Diseases, Female
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on July 20, 2014