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

June 22, 2011 updated by: Lotus Bio Inc.
Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • tel Aviv, Israel, 67443
        • Assuta Medical Centers Ltd.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Semen Quality as determined by the following parameters: Semen volume
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard
Semen pH
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard
Leukocytes concentration
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard
Sperm cells concentration
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard
Motile sperm cell concentration
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard
Total motile sperm cells threshold
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard
Sperm cells morphology
Time Frame: The same day as sevan evaluation according to the gold standard
The same day as sevan evaluation according to the gold standard

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lotus Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • LBI-02-V2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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