NCT03857828

Brief Summary

Measurement of clusterin level in the semen of infertile males undergoing testicular sperm extraction.

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
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

February 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 16, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

Same day

First QC Date

February 26, 2019

Last Update Submit

December 17, 2020

Conditions

Azoospermia, Nonobstructive

Outcome Measures

Primary Outcomes (1)

  • The level of seminal clusterin before testicular sperm Extraction.

    Measurement of seminal clusterin by enzyme-linked immunosorbent assay (ELISA) and correlate them with the outcome of testicular sperm extraction to recognize predictors for spermatogenesis before testicular sperm extraction.

    1 hour

Interventions

semen sampleOTHER

• seminal sample for measuring clusterin level.

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile Male patients (20 - 50 years ) with azoospermia undergoing testicular sperm extraction

You may qualify if:

  • Infertile males , Azoospermia undergoing TESE as a preliminary step for ICSI .
  • Age: 20-50 year

You may not qualify if:

  • males \<20 years and \>50years
  • Cryptorchidism .
  • Testicular Agenesis and testicular atrophy .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Azoospermia, Nonobstructive

Central Study Contacts

Azza Sheshaey, M.B.B.CH

CONTACT

01096906812azzaandel@yahoo.com

Emad Eldien Kamal, Ph.D

CONTACT

01004026100

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 28, 2019

Study Start

December 16, 2020

Primary Completion

December 16, 2020

Study Completion

May 1, 2021

Last Updated

December 21, 2020

Record last verified: 2020-12