NCT02722187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

March 24, 2016

Last Update Submit

March 4, 2019

Conditions

VaricoceleInfertility

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate after the intervention

    one yaer after the intervention

Study Arms (2)

microsurgery

EXPERIMENTAL

40 patients will undergo subinguinal microscopic varicocelectomy

Procedure: subinguinal microscopic varicocelectomy

laparoscopy

ACTIVE COMPARATOR

20 patients will undergo laparoscopic varicocelectomy

Procedure: laparoscopic varicocelectomy

Interventions

subinguinal microscopic varicocelectomyPROCEDURE
microsurgery
laparoscopic varicocelectomyPROCEDURE
laparoscopy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • female infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair and Department of Urology Warsaw Medical University.

Warsaw, 02-005, Poland

RECRUITING

Related Publications (6)

  • Diegidio P, Jhaveri JK, Ghannam S, Pinkhasov R, Shabsigh R, Fisch H. Review of current varicocelectomy techniques and their outcomes. BJU Int. 2011 Oct;108(7):1157-72. doi: 10.1111/j.1464-410X.2010.09959.x. Epub 2011 Mar 24.

    PMID: 21435155RESULT

  • Ollandini G, Liguori G, Ziaran S, Malek T, Mazzon G, de Concilio B, Bucci S, Benvenuto S, Belgrano E, Trombetta C. Varicocele treatment: a 2-centers comparison between non microsurgical open correction, laparoscopic approach and retrograde percutaneous sclerotization on 463 cases. Arch Ital Urol Androl. 2013 Sep 26;85(3):143-8. doi: 10.4081/aiua.2013.3.143.

    PMID: 24085237RESULT

  • Abdel-Meguid TA, Al-Sayyad A, Tayib A, Farsi HM. Does varicocele repair improve male infertility? An evidence-based perspective from a randomized, controlled trial. Eur Urol. 2011 Mar;59(3):455-61. doi: 10.1016/j.eururo.2010.12.008. Epub 2010 Dec 21.

    PMID: 21196073RESULT

  • Cayan S, Shavakhabov S, Kadioglu A. Treatment of palpable varicocele in infertile men: a meta-analysis to define the best technique. J Androl. 2009 Jan-Feb;30(1):33-40. doi: 10.2164/jandrol.108.005967. Epub 2008 Sep 4.

    PMID: 18772487RESULT

  • Al-Kandari AM, Shabaan H, Ibrahim HM, Elshebiny YH, Shokeir AA. Comparison of outcomes of different varicocelectomy techniques: open inguinal, laparoscopic, and subinguinal microscopic varicocelectomy: a randomized clinical trial. Urology. 2007 Mar;69(3):417-20. doi: 10.1016/j.urology.2007.01.057.

    PMID: 17382134RESULT

  • Watanabe M, Nagai A, Kusumi N, Tsuboi H, Nasu Y, Kumon H. Minimal invasiveness and effectivity of subinguinal microscopic varicocelectomy: a comparative study with retroperitoneal high and laparoscopic approaches. Int J Urol. 2005 Oct;12(10):892-8. doi: 10.1111/j.1442-2042.2005.01142.x.

    PMID: 16323983RESULT

MeSH Terms

Conditions

VaricoceleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

March 29, 2016

Study Start

April 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

PL(1)