Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele
NCT ID: NCT04397887
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-01-01
2020-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Men with Azoospermia and varicocele
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
micro-surgical varicocelectomy
Sub-inguinal micro-surgical varicocelectomy
Interventions
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micro-surgical varicocelectomy
Sub-inguinal micro-surgical varicocelectomy
Eligibility Criteria
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Inclusion Criteria
* Palpable varicocele
Exclusion Criteria
* Abnormal Karyotype
* Previous chemotherapy, radiotherapy and or diagnosed maligancy.
* previous testicular of inguinal surgeries.
* secondary azoospermia
18 Years
50 Years
MALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Wael Ragab
Andrology consultant/ lecturer
Locations
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Andrology department, Faculty of Medicine - Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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CairoU Azoospermia Vx TEX101
Identifier Type: -
Identifier Source: org_study_id
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