Role of Transrectal-ultrasound in Evaluation of Azoospermia

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05026190
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

Azoospermia is a word meaning to ejaculates with no spermatozoa without a definite underlying cause .1% of men has azoospermia, representing nearly 10 to 15% of all infertile men. The azoospermia is a major concern in our community. There is no actual epidemiological studies to estimate the actual numbers in Egypt. Azoospermia has several classifications, pre-testicular, testicular & post-testicular cause .The semen analysis is the main investigation done for these patient .The treatment methods range from hormonal therapy to surgery or ICSI . The imaging modalities has developed greatly in the last 3 decades. That it became in several setting as a bedside test or investigation. The main modalities used in azoospermia are scrotal ultrasound, TRUS and MRI. The first TRUS was introduced 1957.

Condition or Disease	Intervention/Treatment	Phase
Infertility Due to Azoospermia	Diagnostic Test: transrectal ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Role of Transrectal-ultrasound in Evaluation of Azoospermia
• Anticipated Study Start Date: Oct 5, 2021
• Anticipated Primary Completion Date: Dec 5, 2022
• Anticipated Study Completion Date: Dec 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: azoospermic patients	Diagnostic Test: transrectal ultrasound; we perform trus to identify the cause of azospermia and its type either obstructive or not

Outcome Measures

Primary Outcome Measures

1. Number of patients With obstructive azoospermia [through study completion ,within average one year.]

2. Number of patient with non obstructive azoospermia [through study completion , within average one year.]

3. Number of patient that will respond to endoscopic treatment [6 month duration]

4. Number of patients that will need sperm extraction [9 month duration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• • Adult patients with azoospermia as identified by semen analysis.

• Age from 18 years to more

Exclusion Criteria:

• • History of operative intervention in the lower urinary tract.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Aziz N. The importance of semen analysis in the context of azoospermia. Clinics (Sao Paulo). 2013;68 Suppl 1:35-8. Review.
• Cocuzza M, Alvarenga C, Pagani R. The epidemiology and etiology of azoospermia. Clinics (Sao Paulo). 2013;68 Suppl 1:15-26. Review.
• Gudeloglu A, Parekattil SJ. Update in the evaluation of the azoospermic male. Clinics (Sao Paulo). 2013;68 Suppl 1:27-34. Review.
• 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.

• Responsible Party: Mohamed ElSharkawy, resident of urology, Assiut University
• ClinicalTrials.gov Identifier: NCT05026190
• Other Study ID Numbers: infertility Azoospermia TRUS
• First Posted: Aug 30, 2021
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Azoospermia

Study Results

No Results Posted as of Aug 30, 2021