Back to resultsRole of Transrectal-ultrasound in Evaluation of Azoospermia
Primary Purpose
Infertility Due to Azoospermia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transrectal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility Due to Azoospermia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
azoospermic patients
Arm Description
Outcomes
Primary Outcome Measures
Number of patients With obstructive azoospermia
Number of patient with non obstructive azoospermia
Number of patient that will respond to endoscopic treatment
Number of patients that will need sperm extraction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05026190
Brief Title
Role of Transrectal-ultrasound in Evaluation of Azoospermia
Official Title
Role of Transrectal-ultrasound in Evaluation of Azoospermia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2021 (Anticipated)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
December 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Due to Azoospermia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
azoospermic patients
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
transrectal ultrasound
Intervention Description
we perform trus to identify the cause of azospermia and its type either obstructive or not
Primary Outcome Measure Information:
Title
Number of patients With obstructive azoospermia
Time Frame
through study completion ,within average one year.
Title
Number of patient with non obstructive azoospermia
Time Frame
through study completion , within average one year.
Title
Number of patient that will respond to endoscopic treatment
Time Frame
6 month duration
Title
Number of patients that will need sperm extraction
Time Frame
9 month duration
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed m elsharkawy
Phone
01065811880
Email
mohamed.20134308@med.au.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23503953
Citation
Aziz N. The importance of semen analysis in the context of azoospermia. Clinics (Sao Paulo). 2013;68 Suppl 1(Suppl 1):35-8. doi: 10.6061/clinics/2013(sup01)05.
Results Reference
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PubMed Identifier
23503952
Citation
Gudeloglu A, Parekattil SJ. Update in the evaluation of the azoospermic male. Clinics (Sao Paulo). 2013;68 Suppl 1(Suppl 1):27-34. doi: 10.6061/clinics/2013(sup01)04.
Results Reference
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PubMed Identifier
23503951
Citation
Cocuzza M, Alvarenga C, Pagani R. The epidemiology and etiology of azoospermia. Clinics (Sao Paulo). 2013;68 Suppl 1(Suppl 1):15-26. doi: 10.6061/clinics/2013(sup01)03.
Results Reference
background
PubMed Identifier
29594932
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.
Results Reference
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Learn more about this trial
Role of Transrectal-ultrasound in Evaluation of Azoospermia
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