Varices; CordNCT03835143
Outcome of Sub-inguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchilagia With Normal Semen
An observational study of Varices; Cord, run by Assiut University at 1 site in Egypt.
Trial summary
varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Varices; Cord
- What is being tested?
- subinguinal varicocelectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2019to 12 Jan 2020
- Phase
- Observational
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: there is no description
Who may be able to join
- Primary varicocele.
- Patient's age more than 20 years.
- Scrotal pain (after exclusion of other causes).
- Normal semen analysis
Who cannot join
- Secondary varicocele.
- Recurrent varicocele.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Sub-inguinal Varicocelectomy in Patients Complaining of Orchialgia With Normal Semen Analysis
varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not.
Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen.
This study will focus on the effect of operation on the semen postoperatively .
- Conditions
- Varices; Cord
- Being tested
- subinguinal varicocelectomy
- Medical subject headings
- Varicose Veins, Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subinguinal varicocelectomyProcedure or surgery
varicocele ligation done at the level of subinguinal region
What is being measured
The primary outcome is the main question the study is designed to answer.
Grades of Motility of sperm in semen analysis
semen analysis
Measured: 3 months after the operation
Secondary outcomes (1)
Count of sperms in semen analysis
semen analysis
Measured: 3 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start12 Mar 2019
- Primary completion12 Sep 2019
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Varices; CordStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdelkader, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835143
- Sponsor's protocol ID
- varicocle pain
- Status last verified
- Apr 2020
- First submitted
- 4 Feb 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18772487Kupis L, Dobronski PA, Radziszewski P. Varicocele as a source of male infertility - current treatment techniques. Cent European J Urol. 2015;68(3):365-70. doi: 10.5173/ceju.2015.642. Epub 2015 Oct 15.
PubMed 26568883Shabana W, Teleb M, Dawod T, Elsayed E, Desoky E, Shahin A, Eladl M, Sorour W. Predictors of improvement in semen parameters after varicocelectomy for male subfertility: A prospective study. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):E579-82. doi: 10.5489/cuaj.2808. Epub 2015 Sep 9.
PubMed 26425217Paick S, Choi WS. Varicocele and Testicular Pain: A Review. World J Mens Health. 2019 Jan;37(1):4-11. doi: 10.5534/wjmh.170010. Epub 2018 May 16.
PubMed 29774668Cho CL, Esteves SC, Agarwal A. Novel insights into the pathophysiology of varicocele and its association with reactive oxygen species and sperm DNA fragmentation. Asian J Androl. 2016 Mar-Apr;18(2):186-93. doi: 10.4103/1008-682X.170441.
PubMed 26732105
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Sub-inguinal Varicocelectomy in Patients Complaining of Orchialgia With Normal Semen Analysis
- ClinicalTrials.gov ID
- NCT03835143
- Acronym / sponsor ID
- varicocle pain
- Conditions
- Varices; Cord
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 8 Feb 2019 (actual)
- 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.
varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not.
Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen.
This study will focus on the effect of operation on the semen postoperatively .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- there is no description
Key inclusion criteria (4 listed)
- Primary varicocele.
- Patient's age more than 20 years.
- Scrotal pain (after exclusion of other causes).
- Normal semen analysis
Key exclusion criteria (2 listed)
- Secondary varicocele.
- Recurrent varicocele.
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 varicocelectomyvaricocele ligation done at the level of subinguinal region | Procedure or surgery | – |
Primary outcome
Grades of Motility of sperm in semen analysis
Time frame: 3 months after the operation
semen analysis
1 secondary outcome
Count of sperms in semen analysis
Time frame: 3 months after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- 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 26568883Kupis L, Dobronski PA, Radziszewski P. Varicocele as a source of male infertility - current treatment techniques. Cent European J Urol. 2015;68(3):365-70. doi: 10.5173/ceju.2015.642. Epub 2015 Oct 15.
- Results publication: PubMed 26425217Shabana W, Teleb M, Dawod T, Elsayed E, Desoky E, Shahin A, Eladl M, Sorour W. Predictors of improvement in semen parameters after varicocelectomy for male subfertility: A prospective study. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):E579-82. doi: 10.5489/cuaj.2808. Epub 2015 Sep 9.
- Results publication: PubMed 29774668Paick S, Choi WS. Varicocele and Testicular Pain: A Review. World J Mens Health. 2019 Jan;37(1):4-11. doi: 10.5534/wjmh.170010. Epub 2018 May 16.
- Results publication: PubMed 26732105Cho CL, Esteves SC, Agarwal A. Novel insights into the pathophysiology of varicocele and its association with reactive oxygen species and sperm DNA fragmentation. Asian J Androl. 2016 Mar-Apr;18(2):186-93. doi: 10.4103/1008-682X.170441.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varices; Cord, run by Assiut University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 27 Apr 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grades of Motility of sperm in semen analysis (time frame: 3 months after the operation). 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 NCT03835143, which also lists 5 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 27 Apr 2020.