Infertility Due to AzoospermiaNCT05026190
Role of Transrectal-ultrasound in Evaluation of Azoospermia
A study testing transrectal ultrasound in people with Infertility Due to Azoospermia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Due to Azoospermia
- What is being tested?
- transrectal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2021to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Adult patients with azoospermia as identified by semen analysis.
- Age from 18 years to more
Who cannot join
- • History of operative intervention in the lower urinary tract.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Infertility Due to Azoospermia
- Being tested
- transrectal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transrectal ultrasoundDiagnostic test
we perform trus to identify the cause of azospermia and its type either obstructive or not
| Study group | Role | What they receive |
|---|---|---|
| azoospermic patients | Other | Not described Receives: Diagnostic Test: transrectal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients With obstructive azoospermia
Measured: through study completion ,within average one year.
Number of patient with non obstructive azoospermia
Measured: through study completion , within average one year.
Number of patient that will respond to endoscopic treatment
Measured: 6 month duration
Number of patients that will need sperm extraction
Measured: 9 month duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Oct 2021 (estimated)
- Primary completion5 Dec 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility Due to AzoospermiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed ElSharkawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026190
- Sponsor's protocol ID
- infertility Azoospermia TRUS
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23503953Gudeloglu 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.
PubMed 23503952Cocuzza 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.
PubMed 23503951Sihag 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.
PubMed 29594932
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transrectal-ultrasound in Evaluation of Azoospermia
- ClinicalTrials.gov ID
- NCT05026190
- Acronym / sponsor ID
- infertility Azoospermia TRUS
- Conditions
- Infertility Due to Azoospermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (estimated)
- Primary completion
- 5 Dec 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| azoospermic patients | Other | Diagnostic Test: transrectal ultrasound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Adult patients with azoospermia as identified by semen analysis.
Key exclusion criteria (1 listed)
- • History of operative intervention in the lower urinary tract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transrectal ultrasoundwe perform trus to identify the cause of azospermia and its type either obstructive or not | Diagnostic test | azoospermic patients |
Primary outcome
Number of patients With obstructive azoospermia
Time frame: through study completion ,within average one year.
Number of patient with non obstructive azoospermia
Time frame: through study completion , within average one year.
Number of patient that will respond to endoscopic treatment
Time frame: 6 month duration
Number of patients that will need sperm extraction
Time frame: 9 month duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 23503953Aziz 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.
- Background: PubMed 23503952Gudeloglu 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.
- Background: PubMed 23503951Cocuzza 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.
- Background: PubMed 29594932Sihag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing transrectal ultrasound in people with Infertility Due to Azoospermia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed m elsharkawy (01065811880, mohamed.20134308@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients With obstructive azoospermia (time frame: through study completion ,within average one year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026190, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.