Clinical trial NCT05330533: Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele
Official title: Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicocele
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile male patients with scrotal varicocele aging over 18 years old.

Brief summary: 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of varicose vein diameter pre and post ejaculation.
timeFrame: within 30 minutes post ejaculation
Secondary outcomes:
measure: Assessment of varicose vein reflux time pre and post ejaculation.
timeFrame: Within 30 minutes post ejaculation
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.
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.
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.