An interventional study of endovasculer embolization of varicocele in Varicocele, sponsored by Assiut University. Status unknown. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
All included patients will undergo the following:
Technique:
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
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: endovasculer embolization of varicocele
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.
semen analyis criteria
sperm number in milion/ml
Time frame: 3 month
semen analysis criteria
sperm motility
Time frame: 3 month
No study locations are listed for this record.
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