Trial to Evaluate Erectile Function, Fertility and Sperm... | NCT00282477

Studies
Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls

NCT00282477

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Aug 7, 2007Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Erectile Dysfunction
Azoospermia

Interventions

Not provided

Countries

Israel

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

Aug 2007

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

Feb 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 25, 2006

First Submission Date that Met QC Criteria

Jan 25, 2006

First Posted Date

Jan 26, 2006Estimated

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

Aug 6, 2007

Last Update Posted Date

Aug 7, 2007Estimated

Description Module

Brief Summary

Bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

30Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males ages 20-35, with at least 2 years of bicycle riding, at least 2 hours a week.

Exclusion Criteria:

History of prostatic surgery, testicular surgery, or single testis,
Patients after chemotherapy,
Patients receiving hormonal therapy,
Patients receiving alpha blockers for any indication.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Uri A. Lindner, M.D	Contact	972-3-5302413		Uri.Lindner@Sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Igael Madgar, M.D	Chaim Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaim Sheba Medical Center	Recruiting	Ramat Gan		5261	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction
D053713	Azoospermia

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided