Epididymal U.S Findings in Asthenozoospermic &Correlation With L.Carnitine Level
- Conditions
- Asthenozoospermia
- Registration Number
- NCT05436080
- Lead Sponsor
- Assiut University
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 80
- 80 married male( 50 asthenzoospermic infertile male and 30 with normal semen male) Age from 18 to 55 years.
- Extreme age
- Single
- Recent L carnitine intake
- Undesended testis
- Genetic cause of inferitility
- Patients with clinical Varicocele
- Azoospermic patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level Baseline The sample size calculation was performed using G.power 3.1.9.2 (Universitat Kiel, Germany). The sample size was calculated as total n ≥65 with an allocation ratio of 5:3 in cases and control groups based on the following considerations: 0.05 α error and 80% power of the study to demonstrate that the percentage of epididymal head echotexture heterogeneity is 60% in infertile men (the primary outcome) compared to 25% in healthy fertile men according to a previous study by (Lotti et al., 2021). 15 cases were added to overcome dropout. Therefore, 80 patients will be allocated as 30 cases in fertile group and 50 cases in infertile group.
Lotti, F., Frizza, F., Balercia, G., Barbonetti, A., Behre, H. M., Calogero, A. E., et al. 2021. 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, 9, 559-576
- Secondary Outcome Measures
Name Time Method Evaluate other epididymal ultrasongraphic findings and study its correlation with seminal parameters and L.carnitine level Baseline Evaluate other epididymal ultrasongraphic findings like( vascularity ,cyst, volume) and study its correlation with seminal parameters and L.carnitine level