Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03341897
Other study ID # VARICOCELE TREATEMENT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date October 1, 2021

Study information

Verified date February 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date October 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Age between 18 to 40 years. 2. Grade three reflux by duplex ultrasound.. 3. Recurrent varicocele after surgical treatement. Exclusion Criteria: - Any contraindication for endovascular therapy regarding radiation or dye or sclerosing agents.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary semen analyis criteria sperm number in milion/ml 3 month
Primary semen analysis criteria sperm motility 3 month
See also
  Status Clinical Trial Phase
Completed NCT00639899 - The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy N/A
Not yet recruiting NCT03281915 - the Effect of Different Modialites of Varicocelectomy on Semen Parameters in Patient With Normal Semen Analysis N/A
Recruiting NCT03540056 - Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
Completed NCT02983656 - Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine N/A
Enrolling by invitation NCT05617261 - Evaluating Patient Tolerability and Success for Penile and Scrotal Urologic Procedures Under Conscious Sedation: A Prospective Study
Not yet recruiting NCT05330533 - Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A
Completed NCT02401087 - The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis
Completed NCT00044369 - Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele N/A
Completed NCT05034406 - The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain N/A
Completed NCT03477149 - EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications N/A
Not yet recruiting NCT05171504 - Lactoferrin and Iron in Seminal Plasma of Varicocele
Completed NCT02335385 - Single Incision Laparoscopic Varicocelectomy N/A
Active, not recruiting NCT03079609 - The Search for Viral and Bacterial Etiology of Varicocele N/A
Not yet recruiting NCT02719093 - Role of FSHR Polymorphism p.N680S in the Therapy With FSH in Patients Who Underwent Varicocele Surgery Phase 4
Enrolling by invitation NCT02033863 - Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE N/A
Recruiting NCT02695199 - Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities N/A
Recruiting NCT02304575 - Quality of Life Among Testicular Cancer Survivors N/A
Completed NCT01463787 - Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial Phase 4
Completed NCT01259258 - Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy Phase 2