Clinical trial NCT05436080: Epididymal U.S Findings in Asthenozoospermic &Correlation With L.Carnitine Level
Official title: Epididymal Ultrasongraphic Findings in Asthenozoospermic Infertile Men and Correlation With Seminal Parameters and L.Carnitine Level
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthenozoospermia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants: Patients will be chosen from those attending the outpatient clinic of department of Dermatology, Venereology and Andrology, Assuit University hospitals

Brief summary: To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males

Detailed description: infertility is a relatively common problem affecting about15-20% of reproductive aged couples. Historically, the cause of infertility was falsified attributed to the female partner, while the male factor, which is either primary or a co factor in 40-60% of cases, has largely been ignored Thus, it is important to evaluate men at the same time with women.(2) The epididymis is an elongated structure, posterolateral to the testis within the scrotal sac. Its primary function is the collection, maturation and transport of sperm from rete testis to the ductus deferens.(1)(3) Testicular spermatozoa are nonfunctional and lack the ability to naturally fertilize an oocyte .After, spermatozoa reach the epididymis they undergo a complicated maturation process leading to biochemical, physiological and functional changes resulting in a functional spermatozo on that is able to successfully fertilize an oocyte (3)(4)(8) Sperm dysfunctions are recognised as the most significant cause of male infertility and many may think that sperm dysfunction is only as a result of defective spermatogenesis. However, it can also be the result of an inadequate epididymal maturation process due to improper epididymal function (6)(7)(8) Scrotal sonography is commonly used for evaluation of the infertile male. While abnormalities of the epididymis like( cysts and calcifications ) are frequently observed during sonographic assessment and their presence has uncertain importance (1)(10)(12)(13) Measurement of acetyl carnitine content of human seminal plasma could be used as a marker of epididymal maturation. Carnitine is present in the epididymis at higher concentrations than in other body tissues in the rat

Eligibility criteria: Inclusion Criteria:

* 80 married male( 50 asthenzoospermic infertile male and 30 with normal semen male) Age from 18 to 55 years.

Exclusion Criteria:

* Extreme age
* Single
* Recent L carnitine intake
* Undesended testis
* Genetic cause of inferitility
* Patients with clinical Varicocele
* Azoospermic patients

Primary outcomes:
measure: Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level
timeFrame: Baseline
Secondary outcomes:
measure: Evaluate other epididymal ultrasongraphic findings and study its correlation with seminal parameters and L.carnitine level
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Emad abdel rahiem taha
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ahmed mahmoud el shibany
role: STUDY_DIRECTOR
References:
citation: Lotti F, Frizza F, Balercia G, Barbonetti A, Behre HM, Calogero AE, Cremers JF, Francavilla F, Isidori AM, Kliesch S, La Vignera S, Lenzi A, Marcou M, Pilatz A, Poolamets O, Punab M, Peraza Godoy MF, Rajmil O, Salvio G, Shaeer O, Weidner W, Maseroli E, Cipriani S, Baldi E, Degl'Innocenti S, Danza G, Caldini AL, Terreni A, Boni L, Krausz C, Maggi M. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology. 2021 Mar;9(2):559-576. doi: 10.1111/andr.12951. Epub 2021 Jan 19.