Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System - Full Text View

Sponsored by:	Lotus Bio Inc.
Information provided by:	Lotus Bio Inc.
ClinicalTrials.gov Identifier:	NCT00734981

Purpose

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

Condition
Male Fertility

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System

Further study details as provided by Lotus Bio Inc.:

Primary Outcome Measures:

Semen Quality as determined by the following parameters: Semen volume [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]
Semen pH [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]
Leukocytes concentration [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]
Sperm cells concentration [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]
Motile sperm cell concentration [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]
Total motile sperm cells threshold [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]
Sperm cells morphology [ Time Frame: The same day as sevan evaluation according to the gold standard ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Semen

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed 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

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Male volunteers

Criteria

Inclusion Criteria:

Capable and willing to sign a consent form and participate in the study
20<Age<45
Male

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734981

Contacts

Contact: Arik Kahana, Md.	972-3-5201527	arikk@assuta.com
Contact: Irena Glass	972-3-7643064	irenag@assuta.co.il

Locations

Israel, -
Assuta Medical Centers Ltd.
tel Aviv, -, Israel, 67443

Sponsors and Collaborators

Lotus Bio Inc.

More Information

Responsible Party:	Assuta Medical Centers Ltd. ( Kahana Arik MD. )
Study ID Numbers:	LBI-02-V2
Study First Received:	August 12, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00734981
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Infertility

ClinicalTrials.gov processed this record on January 16, 2009