Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System
- Conditions
- Male Fertility
- Registration Number
- NCT00734981
- Lead Sponsor
- Lotus Bio Inc.
- Brief Summary
Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
- Capable and willing to sign a consent form and participate in the study
- 20<Age<45
- Male
Exclusion Criteria
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Semen Quality as determined by the following parameters: Semen volume The same day as sevan evaluation according to the gold standard Semen pH The same day as sevan evaluation according to the gold standard Sperm cells concentration The same day as sevan evaluation according to the gold standard Motile sperm cell concentration The same day as sevan evaluation according to the gold standard Sperm cells morphology The same day as sevan evaluation according to the gold standard Leukocytes concentration The same day as sevan evaluation according to the gold standard Total motile sperm cells threshold The same day as sevan evaluation according to the gold standard
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Assuta Medical Centers Ltd.
🇮🇱tel Aviv, Israel