Asthenozoospermia Clinical Trial
Official title:
Epididymal Ultrasongraphic Findings in Asthenozoospermic Infertile Men and Correlation With Seminal Parameters and L.Carnitine Level
To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level | 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 a 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 |
Baseline | |
Secondary | Evaluate other epididymal ultrasongraphic findings and study its correlation with seminal parameters and L.carnitine level | Evaluate other epididymal ultrasongraphic findings like( vascularity ,cyst, volume) and study its correlation with seminal parameters and L.carnitine level | Baseline |
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