Male FertilityNCT00734981
Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System
An observational study of Male Fertility, run by Lotus Bio Inc. at 1 site in Israel.
Trial summary
Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Fertility
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male volunteers
Who may be able to join
- Capable and willing to sign a consent form and participate in the study
- 20<Age<45
- Male
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assuta Medical Centers Ltd.
Tel Aviv, 67443
Arik kahana, Md., 972-3-5201527, arikk@assuta.com
Irina Glass, xxx, 972-3-7643064, irenag@asuuta.co.il
About this study
Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.
Read the 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
- Conditions
- Male Fertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen Quality as determined by the following parameters: Semen volume
Measured: The same day as sevan evaluation according to the gold standard
Semen pH
Measured: The same day as sevan evaluation according to the gold standard
Leukocytes concentration
Measured: The same day as sevan evaluation according to the gold standard
Sperm cells concentration
Measured: The same day as sevan evaluation according to the gold standard
Motile sperm cell concentration
Measured: The same day as sevan evaluation according to the gold standard
Total motile sperm cells threshold
Measured: The same day as sevan evaluation according to the gold standard
Sperm cells morphology
Measured: The same day as sevan evaluation according to the gold standard
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lotus Bio Inc.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734981
- Sponsor's protocol ID
- LBI-02-V2
- Status last verified
- Jun 2011
- First submitted
- 12 Aug 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System
- ClinicalTrials.gov ID
- NCT00734981
- Acronym / sponsor ID
- LBI-02-V2
- Conditions
- Male Fertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lotus Bio Inc.University, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male volunteers
Key inclusion criteria (3 listed)
- Capable and willing to sign a consent form and participate in the study
- 20<Age<45
- Male
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Semen Quality as determined by the following parameters: Semen volume
Time frame: 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
Leukocytes concentration
Time frame: 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
Motile sperm cell concentration
Time frame: 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
Sperm cells morphology
Time frame: The same day as sevan evaluation according to the gold standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Fertility, run by Lotus Bio Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Kahana, Md. (972-3-5201527, arikk@assuta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen Quality as determined by the following parameters: Semen volume (time frame: The same day as sevan evaluation according to the gold standard). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.