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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05330533
Other study ID # Ejaculation effect on Duplex
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date December 2023

Study information

Verified date March 2022
Source Assiut University
Contact Mahmoud Elsebaity, Master
Phone +201065938686
Email mahmoud.elsebaity88@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Infertile male patients. 2. patients with scrotal varicocele. 3. male patients aging over 18 years old. Exclusion Criteria: 1. Pyospermia. 2. Epididymitis. 3. Orchitis. 4. Anejaculation. 5. Recurrent varicocele. 6. Patients who previously underwent scrotal or inguinal surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
scrotal duplex
Scrotal colour doppler ultrasonography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within 30 minutes post ejaculation
Secondary 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. Within 30 minutes post ejaculation
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