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The Role of Microsurgery in Surgical Treatment of Varicocele.

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ClinicalTrials.gov Identifier: NCT02722187
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
This study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.

Condition or disease Intervention/treatment Phase
Varicocele Infertility Procedure: subinguinal microscopic varicocelectomy Procedure: laparoscopic varicocelectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Role of Microsurgery in Surgical Treatment of Varicocele.
Study Start Date : April 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: microsurgery
40 patients will undergo subinguinal microscopic varicocelectomy
Procedure: subinguinal microscopic varicocelectomy
Active Comparator: laparoscopy
20 patients will undergo laparoscopic varicocelectomy
Procedure: laparoscopic varicocelectomy



Primary Outcome Measures :
  1. pregnancy rate after the intervention [ Time Frame: one yaer after the intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical varicocele
  • infertility duration of min one year
  • poor semen quality
  • otherwise unexplained infertility in the couple

Exclusion Criteria:

  • female infertility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722187


Locations
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Poland
Chair and Department of Urology Warsaw Medical University. Recruiting
Warsaw, Poland, 02-005
Contact: Piotr Dobroński, MD PhD    22 502-17-02 ext +48    urologia@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw

Publications of Results:

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02722187     History of Changes
Other Study ID Numbers: microvl/2015
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Infertility
Varicocele
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases