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Status unknownNCT05330533Updated Apr 15, 2022

Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele

An observational study in Varicocele, sponsored by Assiut University. Status unknown. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-15.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

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 .

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Conditions studied

  • Varicocele

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03

In context

Varicocele

57 studies on the registry are indexed under Varicocele; 16 are open to participants now.

This study's planned enrollment of 200 is above the median of 119 across 17 observational studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Infertile male patients with scrotal varicocele aging over 18 years old.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Infertile male patients.
  2. patients with scrotal varicocele.
  3. male patients aging over 18 years old.

Exclusion criteria

Exclusion Criteria:

  1. Pyospermia.
  2. Epididymitis.
  3. Orchitis.
  4. Anejaculation.
  5. Recurrent varicocele.
  6. Patients who previously underwent scrotal or inguinal surgery.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Radiationscrotal duplex

    Scrotal colour doppler ultrasonography

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Within 30 minutes post ejaculation

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Study locations

No study locations are listed for this record.

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References and documents

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 33913191 ↗
  • Bello 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 34552777 ↗
  • Senturk 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 32271466 ↗
  • Sihag 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 29594932 ↗
  • Raveendran 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2022; primary completion for Nov 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2022
First posted
Apr 15, 2022
StartEst.
Nov 1, 2022
Primary completionEst.
Nov 2023
CompletionEst.
Dec 2023
Last update
Apr 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05330533
Lead sponsor
Assiut University
Responsible party
Mahmoud Thabet Mohamed Ali Elsebaity (Principal investigator , resident doctor, Assiut University) — Principal investigator
First posted
Apr 15, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Apr 15, 2022

Study contacts

Mahmoud Elsebaity, Master
Contact
mahmoud.elsebaity88@gmail.com
+201065938686
Emad eldien Ali, professor
Contact
emad@infertility-eg.com
+201155680777

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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