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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00734981
Enrollment
60
Registered
2008-08-14
Start date
2012-01-31
Completion date
2012-12-31
Last updated
2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Fertility

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

Interventions

None listed

Sponsors

Lotus Bio Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frame
Semen Quality as determined by the following parameters: Semen volumeThe same day as sevan evaluation according to the gold standard
Semen pHThe same day as sevan evaluation according to the gold standard
Leukocytes concentrationThe same day as sevan evaluation according to the gold standard
Sperm cells concentrationThe same day as sevan evaluation according to the gold standard
Motile sperm cell concentrationThe same day as sevan evaluation according to the gold standard
Total motile sperm cells thresholdThe same day as sevan evaluation according to the gold standard
Sperm cells morphologyThe same day as sevan evaluation according to the gold standard

Countries

Israel

Contacts

Primary ContactArik Kahana, Md.
arikk@assuta.com972-3-5201527
Backup ContactIrena Glass
irenag@assuta.co.il972-3-7643064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026