VaricocelePhase 4NCT01463787
Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial
A Phase 4 study testing microsurgical varicocelectomy in inguinal approach and microsurgical varicocelectomy in subinguinal approach in people with Varicocele, run by Feng Pan at 1 site in China.
Trial summary
Varicocele is the most common surgical disease which could lead to male infertility. It is found in approximately 15% adult males, and in about 40% infertile males. And the incidence is up to 80% in secondary infertility. Read more about this study
- Who is it for?
- Ages 20 to 46 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- microsurgical varicocelectomy in inguinal approach and microsurgical varicocelectomy in subinguinal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 4
- 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 46 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Primary infertility (more than 1 year)
- Serum hormone was normal (FSH, LH, T and PRL)
- Semen analysis which was taken within 3-7 days of abstinence was abnormal for at least twice, and at least 1 month apart (the value of sperm density was less than 20 million per ml, and/or sperm motility a+b was less than 50%, according to the 4th WHO criteria)
- All varicocele was diagnosed by physical examination and testified by color Doppler ultrasound
- Patients' spouse was healthy in reproduction or had some curable generational diseases
Who cannot join
- Secondary infertility
- Men with subclinical varicocele or normal semen analyses
- Having some other surgical diseases, such as genital tract infection or deformity
- Having some congenital diseases, such as Klinefelter and Y chromosome deficiency
- Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on
- Patients' spouse had some diseases that made them unable to carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Healthcare Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210004
About this study
Varicocele is the most common surgical disease which could lead to male infertility. It is found in approximately 15% adult males, and in about 40% infertile males. And the incidence is up to 80% in secondary infertility. In the past, there was continuous controversy over whether a varicocele repair could improve fertility. But at present, researches are coming to a consensus on the indication of varicocelectomy. Several researches manifest that the microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and lowest complications rate after surgery. Microsurgical varicocelectomy includes two approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There are few studies which make direct comparison between the two methods in microsurgical varicocelectomy, especially in China. Operators have made decisions on the basis of their own experience and skills. In this study, the investigators compare the postoperative spontaneous pregnancy and complications rates in two approaches in microsurgical varicocelectomy for Chinese infertile men in their hospital.
Read the detailed description
Outcome Measures
Before surgery, all patients were diagnosed by physical examination and testified by color Doppler ultrasound. And one trained nurse documented the patients' age, left unilateral or bilateral and the grade of varicocele, and the grade of the more serious side was noted when handled with bilateral ones. During surgery, the duration of surgery was documented. After surgery, a Visual Analogue Scale (VAS) was used to assess the introperative pain after anesthesia recovery and the amount of postoperative pain one month postoperatively by another trained nurse. And the patients whose pain scores > 3 and/or who claimed pain were prescribed with ibuprofen sustained-release capsules (China SmithKline Pharmaceutical Company, Tianjing, China) (0.3g) (ISRC) every 12h on the surgical day (since 2h postoperatively) and only if necessary on the following days (no patient claimed that he had gastrointestinal ulcer history or allergic history of relative drug). Parents were told to write down on a provided form how many times they gave medicine postoperatively. Patients were followed with visits 1 month, 3, 6 and 12 months after surgery, and were encouraged to visit the clinic anytime when they had any complaint in this period. The semen analyses were conducted in the 3, 6 and 12 months in the follow-up. The recurrence or hydrocele formation was testified by color Doppler ultrasound (with/without detected by physical examination) by the same doctor who did the preoperative examination. And this doctor and two nurses mentioned above were all unaware of the patients' groups.
- Conditions
- Varicocele
- Being tested
- microsurgical varicocelectomy in inguinal approach, microsurgical varicocelectomy in subinguinal approach
- Keywords
- Infertility, varicocelectomy, microsurgery, Chinese men, pregnancy rate
- Medical subject headings
- Varicocele, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microsurgical varicocelectomy in inguinal approachProcedure or surgery
In inguinal approach, the incision, which was about 3cm, was made two fingers up the pubic symphysis, from external inguinal rings parallel to the inguinal ligament.
microsurgical varicocelectomy in subinguinal approachProcedure or surgery
In subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring.
| Study group | Role | What they receive |
|---|---|---|
| inguinal group | Experimental | Not described Receives: Procedure: microsurgical varicocelectomy in inguinal approach |
| sub-inguinal group | Active comparator | Not described Receives: Procedure: microsurgical varicocelectomy in subinguinal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Postoperative spontaneous pregnancy is considered to be the best indicator to assess fertility status.
Measured: within the 12-24 months postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Pan, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463787
- Sponsor's protocol ID
- FPan
- Status last verified
- Apr 2013
- First submitted
- 26 Oct 2011
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01463787
- Acronym / sponsor ID
- FPan
- Conditions
- Varicocele
- Keywords
- Infertility, varicocelectomy, microsurgery, Chinese men, pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Feng PanUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Nov 2011 (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.
Varicocele is the most common surgical disease which could lead to male infertility. It is found in approximately 15% adult males, and in about 40% infertile males. And the incidence is up to 80% in secondary infertility. In the past, there was continuous controversy over whether a varicocele repair could improve fertility. But at present, researches are coming to a consensus on the indication of varicocelectomy. Several researches manifest that the microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and lowest complications rate after surgery. Microsurgical varicocelectomy includes two approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There are few studies which make direct comparison between the two methods in microsurgical varicocelectomy, especially in China. Operators have made decisions on the basis of their own experience and skills. In this study, the investigators compare the postoperative spontaneous pregnancy and complications rates in two approaches in microsurgical varicocelectomy for Chinese infertile men in their hospital.
Detailed description
Outcome Measures
Before surgery, all patients were diagnosed by physical examination and testified by color Doppler ultrasound. And one trained nurse documented the patients' age, left unilateral or bilateral and the grade of varicocele, and the grade of the more serious side was noted when handled with bilateral ones. During surgery, the duration of surgery was documented. After surgery, a Visual Analogue Scale (VAS) was used to assess the introperative pain after anesthesia recovery and the amount of postoperative pain one month postoperatively by another trained nurse. And the patients whose pain scores > 3 and/or who claimed pain were prescribed with ibuprofen sustained-release capsules (China SmithKline Pharmaceutical Company, Tianjing, China) (0.3g) (ISRC) every 12h on the surgical day (since 2h postoperatively) and only if necessary on the following days (no patient claimed that he had gastrointestinal ulcer history or allergic history of relative drug). Parents were told to write down on a provided form how many times they gave medicine postoperatively. Patients were followed with visits 1 month, 3, 6 and 12 months after surgery, and were encouraged to visit the clinic anytime when they had any complaint in this period. The semen analyses were conducted in the 3, 6 and 12 months in the follow-up. The recurrence or hydrocele formation was testified by color Doppler ultrasound (with/without detected by physical examination) by the same doctor who did the preoperative examination. And this doctor and two nurses mentioned above were all unaware of the patients' groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inguinal group | Experimental | Procedure: microsurgical varicocelectomy in inguinal approach |
| sub-inguinal group | Active comparator | Procedure: microsurgical varicocelectomy in subinguinal approach |
Who may qualify
- Ages
- 20 to 46 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primary infertility (more than 1 year)
- Serum hormone was normal (FSH, LH, T and PRL)
- Semen analysis which was taken within 3-7 days of abstinence was abnormal for at least twice, and at least 1 month apart (the value of sperm density was less than 20 million per ml, and/or sperm motility a+b was less than 50%, according to the 4th WHO criteria)
- All varicocele was diagnosed by physical examination and testified by color Doppler ultrasound
- Patients' spouse was healthy in reproduction or had some curable generational diseases
Key exclusion criteria (6 listed)
- Secondary infertility
- Men with subclinical varicocele or normal semen analyses
- Having some other surgical diseases, such as genital tract infection or deformity
- Having some congenital diseases, such as Klinefelter and Y chromosome deficiency
- Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on
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 varicocelectomy in inguinal approachIn inguinal approach, the incision, which was about 3cm, was made two fingers up the pubic symphysis, from external inguinal rings parallel to the inguinal ligament. | Procedure or surgery | inguinal group |
| microsurgical varicocelectomy in subinguinal approachIn subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring. | Procedure or surgery | sub-inguinal group |
Primary outcome
pregnancy
Time frame: within the 12-24 months postoperative period
Postoperative spontaneous pregnancy is considered to be the best indicator to assess fertility status.
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 10 Apr 2013.
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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?
A Phase 4 study testing microsurgical varicocelectomy in inguinal approach and microsurgical varicocelectomy in subinguinal approach in people with Varicocele, run by Feng Pan 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 5 inclusion and 6 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 10 Apr 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pregnancy (time frame: within the 12-24 months postoperative period). 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 10 Apr 2013.