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Varicocele Treatement by Endovasculer Embolization

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ClinicalTrials.gov Identifier: NCT03341897
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief 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.


Condition or disease Intervention/treatment Phase
Varicocele Procedure: endovasculer embolization of varicocele Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovasculer Treatement of Male Pelvic Venous Insufficiency
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Arm Intervention/treatment
Experimental: Surgical varicocelectomy 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.





Primary Outcome Measures :
  1. semen analyis criteria [ Time Frame: 3 month ]
    sperm number in milion/ml

  2. semen analysis criteria [ Time Frame: 3 month ]
    sperm motility



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Ahmed Mohamed Abbas, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03341897     History of Changes
Other Study ID Numbers: VARICOCELE TREATEMENT
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed Mohamed Abbas, Assiut University:
embolization
coiling
varicocele

Additional relevant MeSH terms:
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Varicocele
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents