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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Lotus Bio Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Lotus Bio Inc.
ClinicalTrials.gov Identifier:
NCT00734981
First received: August 12, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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


Condition
Male Fertility

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: 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

Semen


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (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
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: 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. Not yet recruiting
tel Aviv, Israel, 67443
Contact: Arik kahana, Md.    972-3-5201527    arikk@assuta.com   
Contact: Irina Glass, xxx    972-3-7643064    irenag@asuuta.co.il   
Sponsors and Collaborators
Lotus Bio Inc.
  More Information

No publications provided

Responsible Party: Kahana Arik MD., Assuta Medical Centers Ltd.
ClinicalTrials.gov Identifier: NCT00734981     History of Changes
Other Study ID Numbers: LBI-02-V2
Study First Received: August 12, 2008
Last Updated: June 22, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on September 16, 2014