VaricoceleNCT02695199
Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities
A study testing Laparoscopic varicocelectomy and Microscopic Subinguinal varicocelectomy in people with Varicocele, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles. Read more about this study
- Who is it for?
- Ages 20 to 39 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Laparoscopic varicocelectomy and Microscopic Subinguinal varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2017
- 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 20 to 39 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;
- impaired semen quality including sperm concentration <15 million/ml or total motility <40% or progressively motile < 32% (a+b), the 5th edited World Health Organization criteria was referred;
- with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;
- patient's spouse was healthy in reproduction.
Who cannot join
- with subclinical varicocele, recurrent varicoceles;
- normal semen analyses;
- other reasons of infertility than varicoceles;
- refusing to enter randomization;
- female partner older than 35 years;
- with abnormal level of serum hormones;
- female factor infertility;
- with significant surgical diseases, congenital diseases or endocrine diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Hospital of Shandong University
Jinan, Shandong, 250033
Mingzhen Yuan, PHD, +8615053155899, yuanmingzhen2005@126.com
Liqiang Guo, MD, +8618253132651, glq_66@yeah.net
About this study
Official title: Comparison Between Laparoscopic Doppler Ultrasound Assisted Laparoscopic Varicocelectomy and Microscopic Subinguinal Varicocelectomy
To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.
Read the detailed description
To compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. To examine the microanatomy of the spermatic cord within suprainguinal portion.
- Conditions
- Varicocele
- Being tested
- Laparoscopic varicocelectomy, Microscopic Subinguinal varicocelectomy
- Keywords
- Doppler Ultrasound, Laparoscopic, Microscopic 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.
Laparoscopic varicocelectomyProcedure or surgery
Also called Laparoscopic varicocelectomy assisted by Doppler ultrasound
Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound
Microscopic Subinguinal varicocelectomyProcedure or surgery
Also called Traditional microscopic Subinguinal varicocelectomy
Infertile patients with clinically palpable varicoceles were selected to receive microscopic Subinguinal varicocelectomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic varicocelectomy | Experimental | laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group Receives: Procedure: Laparoscopic varicocelectomy |
| microscopic varicocelectomy | Sham comparator | conventional Microscopic Subinguinal varicocelectomy group Receives: Procedure: Microscopic Subinguinal varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: The pregnancy rate was calculated at 1 year of follow-up
Secondary outcomes (2)
semen quality assessment
Routine sperm quality check including Count，Morphology and Motility using both the conventional manual method and computer assisted sperm analysis (CASA) systems.
Measured: semen quality assessment were checked at 3, 6 and 12 months after surgery.
postoperative complications
Measured: postoperative complications at 3, 6 and 12 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 posted1 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
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.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingzhen Yuan, MD, Study director, Second hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695199
- Sponsor's protocol ID
- 49557309-6
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Laparoscopic Doppler Ultrasound Assisted Laparoscopic Varicocelectomy and Microscopic Subinguinal Varicocelectomy
- ClinicalTrials.gov ID
- NCT02695199
- Acronym / sponsor ID
- 49557309-6
- Conditions
- Varicocele
- Keywords
- Doppler Ultrasound, Laparoscopic, Microscopic Subinguinal Varicocelectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 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.
To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.
Detailed description
To compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. To examine the microanatomy of the spermatic cord within suprainguinal portion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic varicocelectomy | Experimental | Procedure: Laparoscopic varicocelectomylaparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group |
| microscopic varicocelectomy | Sham comparator | Procedure: Microscopic Subinguinal varicocelectomyconventional Microscopic Subinguinal varicocelectomy group |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;
- impaired semen quality including sperm concentration <15 million/ml or total motility <40% or progressively motile < 32% (a+b), the 5th edited World Health Organization criteria was referred;
- with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;
- patient's spouse was healthy in reproduction.
Key exclusion criteria (8 listed)
- with subclinical varicocele, recurrent varicoceles;
- normal semen analyses;
- other reasons of infertility than varicoceles;
- refusing to enter randomization;
- female partner older than 35 years;
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 |
|---|---|---|
| Laparoscopic varicocelectomyAlso: Laparoscopic varicocelectomy assisted by Doppler ultrasoundTraditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound | Procedure or surgery | laparoscopic varicocelectomy |
| Microscopic Subinguinal varicocelectomyAlso: Traditional microscopic Subinguinal varicocelectomyInfertile patients with clinically palpable varicoceles were selected to receive microscopic Subinguinal varicocelectomy | Procedure or surgery | microscopic varicocelectomy |
Primary outcome
Pregnancy rate
Time frame: The pregnancy rate was calculated at 1 year of follow-up
2 secondary outcomes
semen quality assessment
Time frame: semen quality assessment were checked at 3, 6 and 12 months after surgery.
postoperative complications
Time frame: postoperative complications at 3, 6 and 12 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 1 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Mingzhen Yuan, MD study director
Second hospital of Shandong 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 Laparoscopic varicocelectomy and Microscopic Subinguinal varicocelectomy in people with Varicocele, run by The Second Hospital of Shandong 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 4 inclusion and 8 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 1 Mar 2016. 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. Some participants in this study may receive a placebo. 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?
Contact Shengtian Zhao, PHD (+86053185875401, 398139849@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: The pregnancy rate was calculated at 1 year of follow-up). 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 1 Mar 2016.