VaricoceleNCT05330533
Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele
An observational study of Varicocele, run by Assiut University.
Trial summary
Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- scrotal duplex
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to Dec 2023
- 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 18 to 65 years
- Men only
- Adult, Older adult
Study population: Infertile male patients with scrotal varicocele aging over 18 years old.
Who may be able to join
- Infertile male patients.
- patients with scrotal varicocele.
- male patients aging over 18 years old.
Who cannot join
- Pyospermia.
- Epididymitis.
- Orchitis.
- Anejaculation.
- Recurrent varicocele.
- Patients who previously underwent scrotal or inguinal surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele
Read the detailed description
Varicocele is abnormal dilatation of the pampiniform plexus veins draining the testicles.
It manifests as an abnormal retrograde flow in the internal spermatic venous system or dilation of venous branches in the external cremasteric system .
It affects approximately 15% in the general population, 35 - 40% in men with primary infertility and approximately 80% of men with secondary infertility. It could often concomitantly occur with infertility or chronic scrotal pain causing impaired spermatogenesis and is the most common correctable cause of male infertility. it may affects spermatogenesis via different mechanisms such as increased testicular heat, hormonal disorders and reflux of toxic metabolites.
Scrotal colour Doppler ultrasonography (USG) is a widely used method for evaluation of varicocele patients . It can be used along with physical examination in these patients through evaluation of vein reflux and diameter; in cases where palpation may be problematic. Furthermore, the degree of reflux and vein diameter can be used during the decision-making stage while treating varicocele .
Ejaculation is the process by which sperms move from epididymis via vas deferens to urethra and finally expelled out through the urethral meatus by the contraction of smooth muscles. A normal antegrade ejaculation consists of emission, expulsion (ejection), and orgasm .
In the evaluation of infertile patients, semen analysis is required for evaluation of number, motility and morphology of spermatozoa with scrotal colour Doppler USG. Ejaculation for the purpose of sperm analysis is known to significantly increase testicular blood supply .
- Conditions
- Varicocele
- Being tested
- scrotal duplex
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scrotal duplexRadiation
Scrotal colour doppler ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of varicose vein diameter pre and post ejaculation.
Assessment of the change in varicose vein diameter by scrotal colour doppler ultrasonography pre ejaculation and within 30 minutes post ejaculation.
Measured: within 30 minutes post ejaculation
Secondary outcomes (1)
Assessment of varicose vein reflux time pre and post ejaculation.
Assessment of varicose vein reflux time by scrotal duplex pre ejaculation and within 30 minutes post ejaculation.
Measured: Within 30 minutes post ejaculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Nov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Thabet Mohamed Ali Elsebaity, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330533
- Sponsor's protocol ID
- Ejaculation effect on Duplex
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kizilkan Y, Duran MB, Senel S, Yikilmaz TN, Akbelen B, Toksoz S. The effect of ejaculation time on varicose vein diameter and reflux level. Andrologia. 2021 Aug;53(7):e14090. doi: 10.1111/and.14090. Epub 2021 Apr 28.
PubMed 33913191Bello JO, Bhatti KH, Gherabi N, Philipraj J, Narayan Y, Tsampoukas G, Shaikh N, Papatsoris A, Moussa M, Buchholz N. The usefulness of elastography in the evaluation and management of adult men with varicocele: A systematic review. Arab J Urol. 2021 Sep 16;19(3):255-263. doi: 10.1080/2090598X.2021.1964256. eCollection 2021.
PubMed 34552777Senturk AB, Cakiroglu B, Yaytokgil M, Aydin C, Sungur M, Akkoc A. Effect of venous reflux time on testosterone and semen parameters of infertile males after microscopic varicocelectomy. Andrologia. 2020 Jul;52(6):e13583. doi: 10.1111/and.13583. Epub 2020 Apr 9.
PubMed 32271466Sihag P, Tandon A, Pal R, Jain BK, Bhatt S, Kaur S, Sinha A. Sonography in male infertility: a look beyond the obvious. J Ultrasound. 2018 Sep;21(3):265-276. doi: 10.1007/s40477-018-0294-5. Epub 2018 Mar 28.
PubMed 29594932Raveendran AV, Agarwal A. Premature ejaculation - current concepts in the management: A narrative review. Int J Reprod Biomed. 2021 Jan 25;19(1):5-22. doi: 10.18502/ijrm.v19i1.8176. eCollection 2021 Jan.
PubMed 33553999
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele
- ClinicalTrials.gov ID
- NCT05330533
- Acronym / sponsor ID
- Ejaculation effect on Duplex
- Conditions
- Varicocele
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Apr 2022 (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.
Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele
Detailed description
Varicocele is abnormal dilatation of the pampiniform plexus veins draining the testicles.
It manifests as an abnormal retrograde flow in the internal spermatic venous system or dilation of venous branches in the external cremasteric system .
It affects approximately 15% in the general population, 35 - 40% in men with primary infertility and approximately 80% of men with secondary infertility. It could often concomitantly occur with infertility or chronic scrotal pain causing impaired spermatogenesis and is the most common correctable cause of male infertility. it may affects spermatogenesis via different mechanisms such as increased testicular heat, hormonal disorders and reflux of toxic metabolites.
Scrotal colour Doppler ultrasonography (USG) is a widely used method for evaluation of varicocele patients . It can be used along with physical examination in these patients through evaluation of vein reflux and diameter; in cases where palpation may be problematic. Furthermore, the degree of reflux and vein diameter can be used during the decision-making stage while treating varicocele .
Ejaculation is the process by which sperms move from epididymis via vas deferens to urethra and finally expelled out through the urethral meatus by the contraction of smooth muscles. A normal antegrade ejaculation consists of emission, expulsion (ejection), and orgasm .
In the evaluation of infertile patients, semen analysis is required for evaluation of number, motility and morphology of spermatozoa with scrotal colour Doppler USG. Ejaculation for the purpose of sperm analysis is known to significantly increase testicular blood supply .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Infertile male patients with scrotal varicocele aging over 18 years old.
Key inclusion criteria (3 listed)
- Infertile male patients.
- patients with scrotal varicocele.
- male patients aging over 18 years old.
Key exclusion criteria (6 listed)
- Pyospermia.
- Epididymitis.
- Orchitis.
- Anejaculation.
- Recurrent varicocele.
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 |
|---|---|---|
| scrotal duplexScrotal colour doppler ultrasonography | Radiation | – |
Primary outcome
Assessment of varicose vein diameter pre and post ejaculation.
Time frame: within 30 minutes post ejaculation
Assessment of the change in varicose vein diameter by scrotal colour doppler ultrasonography pre ejaculation and within 30 minutes post ejaculation.
1 secondary outcome
Assessment of varicose vein reflux time pre and post ejaculation.
Time frame: Within 30 minutes post ejaculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 33913191Kizilkan Y, Duran MB, Senel S, Yikilmaz TN, Akbelen B, Toksoz S. The effect of ejaculation time on varicose vein diameter and reflux level. Andrologia. 2021 Aug;53(7):e14090. doi: 10.1111/and.14090. Epub 2021 Apr 28.
- Background: PubMed 34552777Bello JO, Bhatti KH, Gherabi N, Philipraj J, Narayan Y, Tsampoukas G, Shaikh N, Papatsoris A, Moussa M, Buchholz N. The usefulness of elastography in the evaluation and management of adult men with varicocele: A systematic review. Arab J Urol. 2021 Sep 16;19(3):255-263. doi: 10.1080/2090598X.2021.1964256. eCollection 2021.
- Background: PubMed 32271466Senturk AB, Cakiroglu B, Yaytokgil M, Aydin C, Sungur M, Akkoc A. Effect of venous reflux time on testosterone and semen parameters of infertile males after microscopic varicocelectomy. Andrologia. 2020 Jul;52(6):e13583. doi: 10.1111/and.13583. Epub 2020 Apr 9.
- Background: PubMed 29594932Sihag P, Tandon A, Pal R, Jain BK, Bhatt S, Kaur S, Sinha A. Sonography in male infertility: a look beyond the obvious. J Ultrasound. 2018 Sep;21(3):265-276. doi: 10.1007/s40477-018-0294-5. Epub 2018 Mar 28.
- Background: PubMed 33553999Raveendran AV, Agarwal A. Premature ejaculation - current concepts in the management: A narrative review. Int J Reprod Biomed. 2021 Jan 25;19(1):5-22. doi: 10.18502/ijrm.v19i1.8176. eCollection 2021 Jan.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud Elsebaity, Master (+201065938686, mahmoud.elsebaity88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of varicose vein diameter pre and post ejaculation. (time frame: within 30 minutes post ejaculation). 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 NCT05330533, 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 15 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.