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Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele

Primary Purpose

Azoospermia, Nonobstructive, Varicocele

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
micro-surgical varicocelectomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Azoospermia, Nonobstructive focused on measuring Varicocele, Azoospermia, TEX 101

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Azoospermia in at least 2 separate semen analyses
  • Palpable varicocele

Exclusion Criteria:

  • Obstructive azoospermia
  • Abnormal Karyotype
  • Previous chemotherapy, radiotherapy and or diagnosed maligancy.
  • previous testicular of inguinal surgeries.
  • secondary azoospermia

Sites / Locations

  • Andrology department, Faculty of Medicine - Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Men with Azoospermia and varicocele

Arm Description

In this single arm study, TEX 101 is measured in the seminal fluid of all participants, and it will be used as a predictor for appearance of sperms in the ejaculate in 3 and 6 moths follow-up periods

Outcomes

Primary Outcome Measures

Sperm retrieval in ejaculate
finding sperms in the ejaculate
Sperm retrieval in ejaculate
finding sperms in the ejaculate

Secondary Outcome Measures

Full Information

First Posted
May 7, 2020
Last Updated
May 18, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04397887
Brief Title
Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele
Official Title
Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
The aim of the study is to assess if seminal TEX 101 can predict the restoration of spermatogenesis and appearance of sperms in the ejaculate after micro-surgical varicocelectomy among azoospermic patients.
Detailed Description
Male patients (40) cases attending the outpatient clinic of Andrology at KASR EL-AINI university hospitals, all patients presented with azoospermia, age:18-43 years, complaining mainly of infertility or accidently discovered azoospermia during premarital check-up or chronic testicular pain caused by longstanding varicocele. Infertile Non Obstructive Azoospermia (NOA) (n=40) subjected to varicocelectomy and patients evaluated 3 months after varicocelectomy by semen analysis, then according to results population divided into 2 groups: Group A (Responders): Patients with positive semen analysis for sperms 3 months after varicocelectomy. Group B (Non Responders): Patients with no sperms in semen analysis in 3 and/or 6 months after varicocelectomy. Method of Estimation of human TEX101 in semen: A 1 ml collected semen samples were centrifuged for 20 minutes at 1000xg at 4 o C, then supernatant of each sample was collected for estimation of TEX101. The human TEX101 (Testis expressed 101) was assayed by commercially available ELISA kit supplied by Wuhan Fine Biotech Co., Ltd. China. Principle of the procedure: This kit was based on sandwich enzyme-linked immune-sorbent assay technique. Anti- TEX101 antibody was pre-coated onto 96-well plate. The biotin conjugated antibody was used as detection antibodies. The standards, test samples and biotin conjugated detection antibody were added to the wells subsequently, and washed with wash buffer. HRP-Streptavidin was added and unbound conjugates were washed away with wash buffer. TMB substrates were used to visualize HRP enzymatic reaction. TMB was catalyzed by HRP to produce a blue color product that changed into yellow after adding acidic stop solution. The intensity of yellow is proportional to the target amount of sample captured in plate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia, Nonobstructive, Varicocele
Keywords
Varicocele, Azoospermia, TEX 101

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Men with Azoospermia and varicocele
Arm Type
Experimental
Arm Description
In this single arm study, TEX 101 is measured in the seminal fluid of all participants, and it will be used as a predictor for appearance of sperms in the ejaculate in 3 and 6 moths follow-up periods
Intervention Type
Procedure
Intervention Name(s)
micro-surgical varicocelectomy
Intervention Description
Sub-inguinal micro-surgical varicocelectomy
Primary Outcome Measure Information:
Title
Sperm retrieval in ejaculate
Description
finding sperms in the ejaculate
Time Frame
3 months follow-up
Title
Sperm retrieval in ejaculate
Description
finding sperms in the ejaculate
Time Frame
6 months follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Azoospermia in at least 2 separate semen analyses Palpable varicocele Exclusion Criteria: Obstructive azoospermia Abnormal Karyotype Previous chemotherapy, radiotherapy and or diagnosed maligancy. previous testicular of inguinal surgeries. secondary azoospermia
Facility Information:
Facility Name
Andrology department, Faculty of Medicine - Cairo University
City
Cairo
ZIP/Postal Code
12622
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele

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