Risk Factors of Psychiatric Disorders and Sexual Dysfunct... | NCT01893216

Studies
Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men

NCT01893216

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Jul 8, 2013Estimated

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Anxiety
Depression
Sexual Dysfunction
Infertility

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Aug 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Jul 2, 2013

First Submission Date that Met QC Criteria

Jul 5, 2013

First Posted Date

Jul 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2013

Last Update Posted Date

Jul 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wan Zi, Doctor, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men		one year

Secondary Outcomes

Measure	Description	Time Frame
Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zi Wan, MD	Contact	15013063468		zi_wan2012@163.com

Overall Officials

Name	Affiliation	Role
Chunhua Deng, MD	First Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D003863	Depression
D012735	Sexual Dysfunction, Physiological
D007246	Infertility

Ancestor Terms

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided