VaricoceleNCT03281915
the Effect of Different Modialites of Varicocelectomy on Semen Parameters in Patient With Normal Semen Analysis
An observational study of Varicocele, run by Assiut University at 1 site in Egypt.
Trial summary
to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen parameter for patients complaining of varicocele with normal semen parameter (pain is the main complaint) Read more about this study
- Who is it for?
- Ages 19 to 45 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- High inguinal Varicocelectomy and Subinguinal varicocelectomy
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2017to 15 Oct 2018
- 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 19 to 45 years
- Men only
- No healthy volunteers
- Adult
Study population: Male patients undergoing varicocelectomy while having normal semen parameters (doing surgery for other reasons eg. pain)
Who may be able to join
- age more than 19 years old
- primary varicocele
Who cannot join
- secondary varicocele recurrent varicocele age less than 19 years
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit Medical School
Asyut, Assuit, 71621
Abdelrahman M Abdelkader, resident, 01068336396, abdelrahmanmohamed.aa@gmail.com
About this study
Official title: Comparison Between Impact of Inguinal and Subinguinal Approaches of Varicocelectomy on Semen Parameters in Patients With Normal Semen Analysis
to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen parameter for patients complaining of varicocele with normal semen parameter (pain is the main complaint)
Read the detailed description
the varicocele is defined as dilated and incompetent veins within the pampiniform plexus of spermatic cord. varicocele has been described as the most common surgically correctable cause of male subinfertility.this is a disease that devolops during puberty when both endocrine and exocrine function of the testicle dramatically increases, along with testicular blood flow. varicocele only rarely detected in boys less than 10 years. left sided varicocle found in 15% of healthy young men.incontrast, the incidence in sub fertile men approaches 40% bilateral varicocele is uncommon in healthy men (less than 10%) but palpated in 20% in sub fertile men. in-general varicocele don't spontaneously regress. an accurate physical examination remain the corner stone of varicocele diagnosis.
several anatomic features contribute to the predominance of left sided varicocele is the left intrnal spermatic vein longer than the right and it typically joins the left renal vein at a right angle.as result of this character higher venous pressures fair transmited to the left spermatic vein and result in reterograde reflux of blood.
varicocle are associated with testicular atrophhy and varicocle correction can reverse atrophy in adolececnt. there is strong evidence affect semen quality it can cause abnormalties in concentration, motility and morphology.main defect is the motility.
indication of varicocelectomy:
- Large varicoceles in adolescents
- Childhood varicocele with testicular atrophy
- Varicoceles with elevated FSH values, or low testosterone levels
- Varicoceles with scrotal pain
- Cosmetic indication
- Male infertility with pathological semen analysis and varicocele
- Conditions
- Varicocele
- Being tested
- High inguinal Varicocelectomy, Subinguinal varicocelectomy
- Keywords
- infertility, pain, pregnancy
- Medical subject headings
- Varicocele, Infertility, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High inguinal VaricocelectomyProcedure or surgery
Semen parameters after high inguinal varicocelectomy will be collected
Subinguinal varicocelectomyProcedure or surgery
Semen parameters after subinguinal Varicocelectomy will be collected
| Study group | Role | What they receive |
|---|---|---|
| high inguinal approch | Patients undergoing high inguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded Receives: Procedure: High inguinal Varicocelectomy | |
| subinguinal approch | Patients undergoing subinguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded Receives: Procedure: Subinguinal varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen analysis
Motility morphology concentration
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start15 Oct 2017 (estimated)
- Primary completion15 Oct 2018 (estimated)
- Study completion15 Oct 2018 (estimated)
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 VaricoceleStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdelkader, Assiut University
- Investigators
- Ehab O Ahmed, Study director, unaffiliationMohamed I Taha, Study chair, unaffiliationAhmed k mohamed, Study director, unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281915
- Sponsor's protocol ID
- varicocelectomy
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leslie SW, Sajjad H, Siref LE. Varicocele. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448113/
PubMed 28846314Wu X, Liu Q, Zhang R, Wang W, Gao Y. Therapeutic efficacy and safety of laparoscopic surgery versus microsurgery for varicocele of adult males: A meta-analysis. Medicine (Baltimore). 2017 Aug;96(34):e7818. doi: 10.1097/MD.0000000000007818.
PubMed 28834886Canning DA. Re: Sperm Concentration and Forward Motility are Not Correlated with Age in Adolescents with an Idiopathic Varicocele and Symmetrical Testicular Volumes. J Urol. 2017 Sep;198(3):472. doi: 10.1016/j.juro.2017.06.068. Epub 2017 Jun 20. No abstract available.
PubMed 28817895Schmidt B. Membranes in artificial organs. Artif Organs. 1996 May;20(5):375-80. doi: 10.1111/j.1525-1594.1996.tb04519.x.
PubMed 8725614Sedaghatpour D, Berookhim BM. The Role of Varicocele in Male Factor Subfertility. Curr Urol Rep. 2017 Sep;18(9):73. doi: 10.1007/s11934-017-0713-8.
PubMed 28718159
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Impact of Inguinal and Subinguinal Approaches of Varicocelectomy on Semen Parameters in Patients With Normal Semen Analysis
- ClinicalTrials.gov ID
- NCT03281915
- Acronym / sponsor ID
- varicocelectomy
- Conditions
- Varicocele
- Keywords
- infertility, pain, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (estimated)
- Primary completion
- 15 Oct 2018 (estimated)
- Study completion
- 15 Oct 2018 (estimated)
- First posted
- 13 Sep 2017 (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.
to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen parameter for patients complaining of varicocele with normal semen parameter (pain is the main complaint)
Detailed description
the varicocele is defined as dilated and incompetent veins within the pampiniform plexus of spermatic cord. varicocele has been described as the most common surgically correctable cause of male subinfertility.this is a disease that devolops during puberty when both endocrine and exocrine function of the testicle dramatically increases, along with testicular blood flow. varicocele only rarely detected in boys less than 10 years. left sided varicocle found in 15% of healthy young men.incontrast, the incidence in sub fertile men approaches 40% bilateral varicocele is uncommon in healthy men (less than 10%) but palpated in 20% in sub fertile men. in-general varicocele don't spontaneously regress. an accurate physical examination remain the corner stone of varicocele diagnosis.
several anatomic features contribute to the predominance of left sided varicocele is the left intrnal spermatic vein longer than the right and it typically joins the left renal vein at a right angle.as result of this character higher venous pressures fair transmited to the left spermatic vein and result in reterograde reflux of blood.
varicocle are associated with testicular atrophhy and varicocle correction can reverse atrophy in adolececnt. there is strong evidence affect semen quality it can cause abnormalties in concentration, motility and morphology.main defect is the motility.
indication of varicocelectomy:
- Large varicoceles in adolescents
- Childhood varicocele with testicular atrophy
- Varicoceles with elevated FSH values, or low testosterone levels
- Varicoceles with scrotal pain
- Cosmetic indication
- Male infertility with pathological semen analysis and varicocele
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high inguinal approch | – | Procedure: High inguinal VaricocelectomyPatients undergoing high inguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded |
| subinguinal approch | – | Procedure: Subinguinal varicocelectomyPatients undergoing subinguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male patients undergoing varicocelectomy while having normal semen parameters (doing surgery for other reasons eg. pain)
Key inclusion criteria (2 listed)
- age more than 19 years old
- primary varicocele
Key exclusion criteria (1 listed)
- secondary varicocele recurrent varicocele age less than 19 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 |
|---|---|---|
| High inguinal VaricocelectomySemen parameters after high inguinal varicocelectomy will be collected | Procedure or surgery | high inguinal approch |
| Subinguinal varicocelectomySemen parameters after subinguinal Varicocelectomy will be collected | Procedure or surgery | subinguinal approch |
Primary outcome
Semen analysis
Time frame: 3months
Motility morphology concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 28846314Leslie SW, Sajjad H, Siref LE. Varicocele. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448113/
- Background: PubMed 28834886Wu X, Liu Q, Zhang R, Wang W, Gao Y. Therapeutic efficacy and safety of laparoscopic surgery versus microsurgery for varicocele of adult males: A meta-analysis. Medicine (Baltimore). 2017 Aug;96(34):e7818. doi: 10.1097/MD.0000000000007818.
- Background: PubMed 28817895Canning DA. Re: Sperm Concentration and Forward Motility are Not Correlated with Age in Adolescents with an Idiopathic Varicocele and Symmetrical Testicular Volumes. J Urol. 2017 Sep;198(3):472. doi: 10.1016/j.juro.2017.06.068. Epub 2017 Jun 20. No abstract available.
- Background: PubMed 8725614Schmidt B. Membranes in artificial organs. Artif Organs. 1996 May;20(5):375-80. doi: 10.1111/j.1525-1594.1996.tb04519.x.
- Background: PubMed 28718159Sedaghatpour D, Berookhim BM. The Role of Varicocele in Male Factor Subfertility. Curr Urol Rep. 2017 Sep;18(9):73. doi: 10.1007/s11934-017-0713-8.
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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.
Ehab O Ahmed study director
unaffiliation
Mohamed I Taha study chair
unaffiliation
Ahmed k mohamed study director
unaffiliation
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 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 2 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 13 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman M Abdelkader (01068336396, abdelrahmanmohamed.aa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen analysis (time frame: 3months). 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 NCT03281915, 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 13 Sep 2017.