Varicocele; Male Infertile;VaricocelectomyNCT01757548
The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
A study testing open operation and microsurgery in people with Varicocele; Male Infertile;Varicocelectomy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better. Read more about this study
- Who is it for?
- Ages 10 to 50 years, men only
- Conditions the study is for
- Varicocele; Male Infertile;Varicocelectomy
- What is being tested?
- open operation and microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Nov 2020
- 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 10 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy
Who cannot join
- 1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia，or their partner can't bear children
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated hospital，Sun Yat-Sen University.
Guangzhou, Guangdong, 510080
About this study
The purpose of this study is to determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better.
- Being tested
- open operation, microsurgery
- Keywords
- varicocele; male infertile;varicocelectomy
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open operationProcedure or surgery
high ligation of spermatic vein by open operation
microsurgeryProcedure or surgery
high ligation of spermatic vein by microsurgery
| Study group | Role | What they receive |
|---|---|---|
| open operation | Experimental | high ligation of spermatic vein by open operation Receives: Procedure: open operation |
| microsurgery | Experimental | high ligation of spermatic vein by microsurgery Receives: Procedure: microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of semen and the level of sexual hormone
The semen analyses and were sexual hormones determinations conducted before and three and six months after surgery.Then the quality of semen and the level of sexual hormone before and after surgery were compared.
Measured: before and three and six months after surgery
complications
the complications such as recurrence, hydrocele,orchiatrophy and wound infection were assessed one, three and six months postoperation. Color doppler ultrasonography and physical examination are the main methods to assess the complications
Measured: one, three and six months postoperation
Secondary outcomes (1)
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity.
Measured: before and one,three and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicocele; Male Infertile;VaricocelectomyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Yao, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiang Zhou Sun, MD，PhD, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757548
- Sponsor's protocol ID
- S2011010005282
- Status last verified
- Dec 2012
- First submitted
- 14 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT01757548
- Acronym / sponsor ID
- S2011010005282
- Keywords
- varicocele; male infertile;varicocelectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 31 Dec 2012 (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 determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open operation | Experimental | Procedure: open operationhigh ligation of spermatic vein by open operation |
| microsurgery | Experimental | Procedure: microsurgeryhigh ligation of spermatic vein by microsurgery |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy
Key exclusion criteria (1 listed)
- 1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia，or their partner can't bear children
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 |
|---|---|---|
| open operationhigh ligation of spermatic vein by open operation | Procedure or surgery | open operation |
| microsurgeryhigh ligation of spermatic vein by microsurgery | Procedure or surgery | microsurgery |
Primary outcome
the quality of semen and the level of sexual hormone
Time frame: before and three and six months after surgery
The semen analyses and were sexual hormones determinations conducted before and three and six months after surgery.Then the quality of semen and the level of sexual hormone before and after surgery were compared.
complications
Time frame: one, three and six months postoperation
the complications such as recurrence, hydrocele,orchiatrophy and wound infection were assessed one, three and six months postoperation. Color doppler ultrasonography and physical examination are the main methods to assess the complications
1 secondary outcome
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
Time frame: before and one,three and six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
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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.
Xiang Zhou Sun, MD，PhD study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open operation and microsurgery in people with Varicocele; Male Infertile;Varicocelectomy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 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 31 Dec 2012. 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 China. 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?
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?
the quality of semen and the level of sexual hormone (time frame: before and three and six months after surgery). The study lists 2 primary outcomes in all. 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 31 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.