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