VaricoceleNCT02722187
The Role of Microsurgery in Surgical Treatment of Varicocele.
A study testing subinguinal microscopic varicocelectomy and laparoscopic varicocelectomy in people with Varicocele and Infertility, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Varicocele, Infertility
- What is being tested?
- subinguinal microscopic varicocelectomy and laparoscopic varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical varicocele
- infertility duration of min one year
- poor semen quality
- otherwise unexplained infertility in the couple
Who cannot join
- female infertility
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Chair and Department of Urology Warsaw Medical University.
Warsaw, 02-005
Piotr Dobroński, MD PhD, 22 502-17-02 ext. +48, urologia@wum.edu.pl
About this study
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.
- Conditions
- Varicocele, Infertility
- Being tested
- subinguinal microscopic varicocelectomy, laparoscopic varicocelectomy
- Medical subject headings
- Varicocele, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subinguinal microscopic varicocelectomyProcedure or surgery
laparoscopic varicocelectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| microsurgery | Experimental | 40 patients will undergo subinguinal microscopic varicocelectomy Receives: Procedure: subinguinal microscopic varicocelectomy |
| laparoscopy | Active comparator | 20 patients will undergo laparoscopic varicocelectomy Receives: Procedure: laparoscopic varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate after the intervention
Measured: one yaer after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722187
- Sponsor's protocol ID
- microvl/2015
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2016
- Last updated
- 5 Mar 2019
- Results posted
- No
Publications
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.
PubMed 21435155Ollandini 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.
PubMed 24085237Abdel-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.
PubMed 21196073Cayan 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.
PubMed 18772487Al-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.
PubMed 17382134Watanabe 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.
PubMed 16323983
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Microsurgery in Surgical Treatment of Varicocele.
- ClinicalTrials.gov ID
- NCT02722187
- Acronym / sponsor ID
- microvl/2015
- Conditions
- Varicocele, Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microsurgery | Experimental | Procedure: subinguinal microscopic varicocelectomy40 patients will undergo subinguinal microscopic varicocelectomy |
| laparoscopy | Active comparator | Procedure: laparoscopic varicocelectomy20 patients will undergo laparoscopic varicocelectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical varicocele
- infertility duration of min one year
- poor semen quality
- otherwise unexplained infertility in the couple
Key exclusion criteria (1 listed)
- female infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subinguinal microscopic varicocelectomy | Procedure or surgery | microsurgery |
| laparoscopic varicocelectomy | Procedure or surgery | laparoscopy |
Primary outcome
pregnancy rate after the intervention
Time frame: one yaer after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Results publication: PubMed 21435155Diegidio 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.
- Results publication: PubMed 24085237Ollandini 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.
- Results publication: PubMed 21196073Abdel-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.
- Results publication: PubMed 18772487Cayan 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.
- Results publication: PubMed 17382134Al-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.
- Results publication: PubMed 16323983Watanabe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chair and Department of Urology Warsaw Medical University.
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subinguinal microscopic varicocelectomy and laparoscopic varicocelectomy in people with Varicocele and Infertility, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate after the intervention (time frame: one yaer after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722187, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.