VaricoceleNCT02006316
Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters for Causes Other Than Infertility
An observational study of Varicocele, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether clinical varicoceles are associated with abnormal semen parameters and whether varicocelectomy could improve the semen parameter in patients unrelated with infertility. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Microsurgical subinguinal varicocelectomy
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2000to Mar 2010
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Study population: men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
Who may be able to join
- men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
Who cannot join
- adolescents
- men with proven fertility or azoospermia
- men with preoperative normal sperm analysis
- available data to compare between preoperative and postoperative semen analyses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters in Patients Who Underwent Surgery for Causes Other Than Infertility
The purpose of this study is to evaluate whether clinical varicoceles are associated with abnormal semen parameters and whether varicocelectomy could improve the semen parameter in patients unrelated with infertility.
Read the detailed description
While most studies are continued to validate the observations of significant improvements in sperm density and motility after varicocele ligation in infertile patients, there have been few studies to investigate the effects of varicocelectomy on semen parameters in adult men unrelated with infertility. The purpose of this study was to determine whether varicocelectomy could improve the semen parameter of these patients as well as whether clinical varicoceles are associated with abnormal semen parameters in patients unrelated with infertility.
- Conditions
- Varicocele
- Being tested
- Microsurgical subinguinal varicocelectomy
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical subinguinal varicocelectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| varicoceles | men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass Receives: Procedure: Microsurgical subinguinal varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration, motility, and morphology
To observe the change of sperm concentration, motility, and morphology pre and postoperatively in the patients of inclusion criteria
Measured: at postoperative 4months
Secondary outcomes (1)
whether semen analysis should be done in men with clinical varicocele regardless of the chief complaint
this result would show the need of performing semen analysis even in the patients with clinical varicocels due to causes other than infertility
Measured: at postoperative 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2000
- Primary completionApr 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Woong Kim, MD, Seoul National University Hospital
- Investigators
- Soo Woong Kim, M.D.,Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006316
- Sponsor's protocol ID
- SeoulNUH
- Status last verified
- May 2014
- First submitted
- 17 Mar 2010
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters in Patients Who Underwent Surgery for Causes Other Than Infertility
- ClinicalTrials.gov ID
- NCT02006316
- Acronym / sponsor ID
- SeoulNUH
- Conditions
- Varicocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Apr 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Dec 2013 (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.
The purpose of this study is to evaluate whether clinical varicoceles are associated with abnormal semen parameters and whether varicocelectomy could improve the semen parameter in patients unrelated with infertility.
Detailed description
While most studies are continued to validate the observations of significant improvements in sperm density and motility after varicocele ligation in infertile patients, there have been few studies to investigate the effects of varicocelectomy on semen parameters in adult men unrelated with infertility. The purpose of this study was to determine whether varicocelectomy could improve the semen parameter of these patients as well as whether clinical varicoceles are associated with abnormal semen parameters in patients unrelated with infertility.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| varicoceles | – | Procedure: Microsurgical subinguinal varicocelectomymen with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
Key inclusion criteria (1 listed)
- men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
Key exclusion criteria (4 listed)
- adolescents
- men with proven fertility or azoospermia
- men with preoperative normal sperm analysis
- available data to compare between preoperative and postoperative semen analyses
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 |
|---|---|---|
| Microsurgical subinguinal varicocelectomy | Procedure or surgery | varicoceles |
Primary outcome
Sperm concentration, motility, and morphology
Time frame: at postoperative 4months
To observe the change of sperm concentration, motility, and morphology pre and postoperatively in the patients of inclusion criteria
1 secondary outcome
whether semen analysis should be done in men with clinical varicocele regardless of the chief complaint
Time frame: at postoperative 4months
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 14 May 2014.
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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.
Soo Woong Kim, M.D.,Ph.D. study chair
Seoul National University Hospital
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 Varicocele, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 14 May 2014. 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 South Korea. 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?
Sperm concentration, motility, and morphology (time frame: at postoperative 4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2014.