VaricoceleNCT03341897
Varicocele Treatement by Endovasculer Embolization
A study testing endovasculer embolization of varicocele in people with Varicocele, run by Assiut University.
Trial summary
A varicocele is a collection of varicose veins within the pampiniform (spermatic) plexus secondary to reflux in the internal spermatic vein (ISV).The condition affects 10% to 15% of the general population but is detected in as many as 40% of men undergoing an infertility workup. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- endovasculer embolization of varicocele
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Oct 2021
- Phase
- Interventional
- 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
- Age between 18 to 40 years.
- Grade three reflux by duplex ultrasound..
- Recurrent varicocele after surgical treatement.
Who cannot join
- Any contraindication for endovascular therapy regarding radiation or dye or sclerosing agents.
About this study
Official title: Endovasculer Treatement of Male Pelvic Venous Insufficiency
A varicocele is a collection of varicose veins within the pampiniform (spermatic) plexus secondary to reflux in the internal spermatic vein (ISV).The condition affects 10% to 15% of the general population but is detected in as many as 40% of men undergoing an infertility workup. Depending on the method used for diagnosis, varicoceles are reported as bilateral in 17% to 77% of men. Traditionally, the diagnosis was made through clinical examination; however,as with other venous reflux disorders, ultrasound has become the mainstay of diagnosis. The traditional indications for treatment include infertility in patients with appropriate semen abnormalities, chronic groin pain, testicular atrophy in adolescent varicoceles, and recurrent varicocele after previous repair. Other indications more recently described with variable strength of evidence include low serum testosterone (with or without erectile dysfunction), benign prostatic hypertrophy,enhancement of assisted fertility techniques, and recurrent first trimester pregnancy loss.Infertility affects 10% to 15% of men of reproductive age. In approximately 50%, a cause is not found. The proof that varicocele repair improves fertility remains elusive; however, there is general acceptance that treatment does improve abnormalities of semen production.The traditional measures to assess semen production are sperm motility,morphology, and total sperm count. However, sperm counts greatly vary from day to day in any individual patient, and these measures correlate poorly with infertility outcomes.
The investigators do this study to evaluate the effectiveness of endovascular therapy using coils and other sclerosing agents and compare their results with other traditonal surgical methods in treatement of varicocele.
Read the detailed description
All included patients will undergo the following:
- History \& examination
- Semen analysis preintervention.
- Scrotal duplex scan of testicular vessels and testicular size .
Technique:
- All interventions will be performed in the endovascular OR with set on C-ARM.
- Patient's position and comfort are issues that are important initially.
STEPS FOR SPERMATIC VENOGRAPHY AND VARICOCELE EMBOLIZATION
Step 1: Vascular Access
Access can be achieved via the internal jugular or femo¬ral veins. Our preferred method is to puncture the right internal jugular vein under ultrasound guidance.
Step 2: Left Renal Vein Injection
During left renal vein injection, the origin of the left spermatic vein is noted .
Step 3: Left Spermatic Vein Catheterization
The catheter is manipulated into the left spermatic vein. A varicocele is present if the contrast refluxes into the pampiniform plexus. If the direction of flow is antegrade, this is considered to represent a negative spermatic venogram.
Step 4: Spermatic Vein Occlusion
If varicocele is confirmed, the spermatic vein is occluded, preferably immediately above the internal inguinal ring and along its full length to within 2 to 3 cm of its origin. The use of liquid embolics with or without metallic coils has become the most common method. Embolization with coils alone without liquid should be avoided, even for "straightforward" cases due to a high rate of recurrence. It is important to look for collaterals throughout the procedure, which may only become visible after distal occlusion . These collaterals are the usual cause of technical failure or recurrence and therefore must be occluded. Options for occlusion methods are described as follows.
Some practitioners place coils in the distal ISV before injecting glue. Coils in the proximal ISV are not necessary. Avoiding injection of glue into the scrotum is essential, either by previously placed distal coils or external compression. Overinjection of glue will result in extension into the renal vein or embolization into the pulmonary artery.
Step 5: Right Spermatic Venography
The same steps performed for the left spermatic vein are repeated for the right spermatic vein, except that the right spermatic vein usually arises directly from the infe¬rior vena cava. If reflux is demonstrated, embolization is performed in the same manner as on the left. The right spermatic vein arises from the inferior vena cava at an acute angle, which can make catheterization from the femoral route especially difficult.
POSTPROCEDURE CARE
The patient is kept in bed for 1 hour postprocedure. The patient is advised to take anti-inflammatory agents as needed and to avoid any activity involving the Valsalva maneuver, such as lifting, vigorous, or "hitting type" sports for 3 full days beginning the day after the proce¬dure. Most patients report a minor dull ache in the back or groin lasting < 2 to 5 days. Fewer than 5% of patients will develop more severe pain lasting up to 14 days, requiring oral analgesics and anti-inflammatory agents and avoidance of vigorous exercise
- Conditions
- Varicocele
- Being tested
- endovasculer embolization of varicocele
- Keywords
- embolization, coiling, varicocele
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovasculer embolization of varicoceleProcedure or surgery
Step 1: Vascular Access
Access can be achieved via the internal jugular or femoral veins. Step 2: Left Renal Vein Injection Step 3: Left Spermatic Vein Catheterization Step 4: Spermatic Vein Occlusion Step 5: Right Spermatic Venography POSTPROCEDURE CARE
The patient is kept in bed for 1 hour postprocedure. The patient is advised to take anti-inflammatory agents as needed and to avoid any activity involving the Valsalva maneuver, such as lifting, vigorous, or "hitting type" sports for 3 full days beginning the day after the proce¬dure. Most patients report a minor dull ache in the back or groin lasting < 2 to 5 days. Fewer than 5% of patients will develop more severe pain lasting up to 14 days, requiring oral analgesics and anti-inflammatory agents and avoidance of vigorous exercise.
| Study group | Role | What they receive |
|---|---|---|
| Surgical varicocelectomy | Experimental | Not described Receives: Procedure: endovasculer embolization of varicocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
semen analyis criteria
sperm number in milion/ml
Measured: 3 month
semen analysis criteria
sperm motility
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341897
- Sponsor's protocol ID
- VARICOCELE TREATEMENT
- Status last verified
- Feb 2021
- First submitted
- 3 Oct 2017
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovasculer Treatement of Male Pelvic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT03341897
- Acronym / sponsor ID
- VARICOCELE TREATEMENT
- Conditions
- Varicocele
- Keywords
- embolization, coiling, varicocele
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 14 Nov 2017 (actual)
- 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.
A varicocele is a collection of varicose veins within the pampiniform (spermatic) plexus secondary to reflux in the internal spermatic vein (ISV).The condition affects 10% to 15% of the general population but is detected in as many as 40% of men undergoing an infertility workup. Depending on the method used for diagnosis, varicoceles are reported as bilateral in 17% to 77% of men. Traditionally, the diagnosis was made through clinical examination; however,as with other venous reflux disorders, ultrasound has become the mainstay of diagnosis. The traditional indications for treatment include infertility in patients with appropriate semen abnormalities, chronic groin pain, testicular atrophy in adolescent varicoceles, and recurrent varicocele after previous repair. Other indications more recently described with variable strength of evidence include low serum testosterone (with or without erectile dysfunction), benign prostatic hypertrophy,enhancement of assisted fertility techniques, and recurrent first trimester pregnancy loss.Infertility affects 10% to 15% of men of reproductive age. In approximately 50%, a cause is not found. The proof that varicocele repair improves fertility remains elusive; however, there is general acceptance that treatment does improve abnormalities of semen production.The traditional measures to assess semen production are sperm motility,morphology, and total sperm count. However, sperm counts greatly vary from day to day in any individual patient, and these measures correlate poorly with infertility outcomes.
The investigators do this study to evaluate the effectiveness of endovascular therapy using coils and other sclerosing agents and compare their results with other traditonal surgical methods in treatement of varicocele.
Detailed description
All included patients will undergo the following:
- History \& examination
- Semen analysis preintervention.
- Scrotal duplex scan of testicular vessels and testicular size .
Technique:
- All interventions will be performed in the endovascular OR with set on C-ARM.
- Patient's position and comfort are issues that are important initially.
STEPS FOR SPERMATIC VENOGRAPHY AND VARICOCELE EMBOLIZATION
Step 1: Vascular Access
Access can be achieved via the internal jugular or femo¬ral veins. Our preferred method is to puncture the right internal jugular vein under ultrasound guidance.
Step 2: Left Renal Vein Injection
During left renal vein injection, the origin of the left spermatic vein is noted .
Step 3: Left Spermatic Vein Catheterization
The catheter is manipulated into the left spermatic vein. A varicocele is present if the contrast refluxes into the pampiniform plexus. If the direction of flow is antegrade, this is considered to represent a negative spermatic venogram.
Step 4: Spermatic Vein Occlusion
If varicocele is confirmed, the spermatic vein is occluded, preferably immediately above the internal inguinal ring and along its full length to within 2 to 3 cm of its origin. The use of liquid embolics with or without metallic coils has become the most common method. Embolization with coils alone without liquid should be avoided, even for "straightforward" cases due to a high rate of recurrence. It is important to look for collaterals throughout the procedure, which may only become visible after distal occlusion . These collaterals are the usual cause of technical failure or recurrence and therefore must be occluded. Options for occlusion methods are described as follows.
Some practitioners place coils in the distal ISV before injecting glue. Coils in the proximal ISV are not necessary. Avoiding injection of glue into the scrotum is essential, either by previously placed distal coils or external compression. Overinjection of glue will result in extension into the renal vein or embolization into the pulmonary artery.
Step 5: Right Spermatic Venography
The same steps performed for the left spermatic vein are repeated for the right spermatic vein, except that the right spermatic vein usually arises directly from the infe¬rior vena cava. If reflux is demonstrated, embolization is performed in the same manner as on the left. The right spermatic vein arises from the inferior vena cava at an acute angle, which can make catheterization from the femoral route especially difficult.
POSTPROCEDURE CARE
The patient is kept in bed for 1 hour postprocedure. The patient is advised to take anti-inflammatory agents as needed and to avoid any activity involving the Valsalva maneuver, such as lifting, vigorous, or "hitting type" sports for 3 full days beginning the day after the proce¬dure. Most patients report a minor dull ache in the back or groin lasting < 2 to 5 days. Fewer than 5% of patients will develop more severe pain lasting up to 14 days, requiring oral analgesics and anti-inflammatory agents and avoidance of vigorous exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical varicocelectomy | Experimental | Procedure: endovasculer embolization of varicocele |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 to 40 years.
- Grade three reflux by duplex ultrasound..
- Recurrent varicocele after surgical treatement.
Key exclusion criteria (1 listed)
- Any contraindication for endovascular therapy regarding radiation or dye or sclerosing agents.
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 |
|---|---|---|
| endovasculer embolization of varicoceleStep 1: Vascular Access Access can be achieved via the internal jugular or femoral veins. Step 2: Left Renal Vein Injection Step 3: Left Spermatic Vein Catheterization Step 4: Spermatic Vein Occlusion Step 5: Right Spermatic Venography POSTPROCEDURE CARE The patient is kept in bed for 1 hour postprocedure. The patient is advised to take anti-inflammatory agents as needed and to avoid any activity involving the Valsalva maneuver, such as lifting, vigorous, or "hitting type" sports for 3 full days beginning the day after the proce¬dure. Most patients report a minor dull ache in the back or groin lasting < 2 to 5 days. Fewer than 5% of patients will develop more severe pain lasting up to 14 days, requiring oral analgesics and anti-inflammatory agents and avoidance of vigorous exercise. | Procedure or surgery | Surgical varicocelectomy |
Primary outcome
semen analyis criteria
Time frame: 3 month
sperm number in milion/ml
semen analysis criteria
Time frame: 3 month
sperm motility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing endovasculer embolization of varicocele in people with Varicocele, run by Assiut University.
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 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semen analyis criteria (time frame: 3 month). The study lists 2 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 15 Feb 2021.