Role of Transrectal-ultrasound in Evaluation of Azoospermia

August 23, 2021 updated by: Mohamed ElSharkawy, Assiut University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients With obstructive azoospermia
Time Frame: through study completion ,within average one year.
through study completion ,within average one year.
Number of patient with non obstructive azoospermia
Time Frame: through study completion , within average one year.
through study completion , within average one year.
Number of patient that will respond to endoscopic treatment
Time Frame: 6 month duration
6 month duration
Number of patients that will need sperm extraction
Time Frame: 9 month duration
9 month duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 5, 2021

Primary Completion (ANTICIPATED)

December 5, 2022

Study Completion (ANTICIPATED)

December 5, 2022

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (ACTUAL)

August 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • infertility Azoospermia TRUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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