Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System
1 other identifier
observational
60
1 country
1
Brief Summary
Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 23, 2011
June 1, 2011
5 months
August 12, 2008
June 22, 2011
Conditions
Outcome Measures
Primary Outcomes (7)
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
Leukocytes concentration
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
Total motile sperm cells threshold
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
Eligibility Criteria
Male volunteers
You may qualify if:
- Capable and willing to sign a consent form and participate in the study
- \<Age\<45
- Male
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lotus Bio Inc.lead
Study Sites (1)
Assuta Medical Centers Ltd.
Tel Aviv, 67443, Israel
Biospecimen
Semen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
January 1, 2012
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
June 23, 2011
Record last verified: 2011-06