Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System

Male Fertility Clinical Trial

Official title:

Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00734981
• Other study ID #: LBI-02-V2
• Status: Not yet recruiting
• Phase: N/A
• First received: August 12, 2008
• Last updated: June 22, 2011
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Lotus Bio Inc.
• Contact: Arik Kahana, Md.
• Phone: 972-3-5201527
• Email: arikk[@]assuta.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.

Description:

Quantities assessment of semen quality as defined by:

Semen volume, semen pH, leukocytes concentration, sperm cells concentration, motile sperm cell concentration, total motile sperm cells threshold and sperm cells morphology

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Capable and willing to sign a consent form and participate in the study

• 20<Age<45

• Male

Exclusion Criteria:

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Male Fertility

Locations

Country	Name	City	State
Israel	Assuta Medical Centers Ltd.	tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Lotus Bio Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semen Quality as determined by the following parameters: Semen volume		The same day as sevan evaluation according to the gold standard	No
Primary	Semen pH		The same day as sevan evaluation according to the gold standard	No
Primary	Leukocytes concentration		The same day as sevan evaluation according to the gold standard	No
Primary	Sperm cells concentration		The same day as sevan evaluation according to the gold standard	No
Primary	Motile sperm cell concentration		The same day as sevan evaluation according to the gold standard	No
Primary	Total motile sperm cells threshold		The same day as sevan evaluation according to the gold standard	No
Primary	Sperm cells morphology		The same day as sevan evaluation according to the gold standard	No