HerniaPhase 2/3NCT00282074
Evaluating Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Fertile Males
A Phase 2/3 study testing laparoscopic bilateral hernia repair in people with Hernia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
In this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Hernia
- What is being tested?
- laparoscopic bilateral hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to not given
- Phase
- Phase 2/3
- 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to have a sperm test both prior to and following surgery.
Who cannot join
- History of prostatic surgery, testicular surgery, azospermia on first spermatogram, single testis, patients after chemotherapy, patients receiving hormonal therapy, patients receiving alpha blockers for any indication, patients who are receiving or received oral antifungal therapy six months prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Trial to Evaluate Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Males in the Fertility Age
In this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume.
- Conditions
- Hernia
- Being tested
- laparoscopic bilateral hernia repair
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic bilateral hernia repairProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Joseph Kuriansky, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282074
- Sponsor's protocol ID
- SHEBA-05-3945-JK-CTIL
- Status last verified
- Jan 2007
- First submitted
- 24 Jan 2006
- Last updated
- 24 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial to Evaluate Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Males in the Fertility Age
- ClinicalTrials.gov ID
- NCT00282074
- Acronym / sponsor ID
- SHEBA-05-3945-JK-CTIL
- Conditions
- Hernia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2006
- First posted
- 25 Jan 2006 (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.
In this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to have a sperm test both prior to and following surgery.
Key exclusion criteria (1 listed)
- History of prostatic surgery, testicular surgery, azospermia on first spermatogram, single testis, patients after chemotherapy, patients receiving hormonal therapy, patients receiving alpha blockers for any indication, patients who are receiving or received oral antifungal therapy six months prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic bilateral hernia repair | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2007.
Related trials for Hernia
RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
Inguinal Hernia, Incarcerated Inguinal Hernia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
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.
Joseph Kuriansky, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing laparoscopic bilateral hernia repair in people with Hernia, run by Sheba Medical Center 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 1 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: stopped early, as of the sponsor's last update on 24 Jan 2007. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 24 Jan 2007.