NCT05026190

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

August 4, 2021

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of patients With obstructive azoospermia

    through study completion ,within average one year.

  • Number of patient with non obstructive azoospermia

    through study completion , within average one year.

  • Number of patient that will respond to endoscopic treatment

    6 month duration

  • Number of patients that will need sperm extraction

    9 month duration

Study Arms (1)

azoospermic patients

OTHER
Diagnostic Test: transrectal ultrasound

Interventions

transrectal ultrasoundDIAGNOSTIC_TEST

we perform trus to identify the cause of azospermia and its type either obstructive or not

azoospermic patients

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients with azoospermia as identified by semen analysis.
  • Age from 18 years to more

You may not qualify if:

  • History of operative intervention in the lower urinary tract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23503953BACKGROUND
  • 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.

    PMID: 23503952BACKGROUND
  • 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.

    PMID: 23503951BACKGROUND
  • 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.

    PMID: 29594932BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident of urology

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 30, 2021

Study Start

October 5, 2021

Primary Completion

December 5, 2022

Study Completion

December 5, 2022

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share