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

NCT ID: NCT00734981

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Male Fertility

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lotus Bio Inc.

OTHER

Sponsor Role lead

Responsible Party

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Assuta Medical Centers Ltd.

Locations

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Assuta Medical Centers Ltd.

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Arik Kahana, Md.

Role: CONTACT

972-3-5201527

Irena Glass

Role: CONTACT

972-3-7643064

Facility Contacts

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Arik kahana, Md.

Role: primary

972-3-5201527

Irina Glass, xxx

Role: backup

972-3-7643064

Other Identifiers

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LBI-02-V2

Identifier Type: -

Identifier Source: org_study_id

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