An interventional study of micro-surgical varicocelectomy in Azoospermia, Nonobstructive and Varicocele, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic
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.
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.
23 studies on the registry are indexed under Azoospermia, Nonobstructive; 7 are open to participants now.
This study's enrollment of 40 is below the median of 61 across 12 interventional studies indexed under Azoospermia, Nonobstructive.
Browse Azoospermia, Nonobstructive studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
Procedure: micro-surgical varicocelectomy
Sub-inguinal micro-surgical varicocelectomy
Sperm retrieval in ejaculate
finding sperms in the ejaculate
Time frame: 3 months follow-up
Sperm retrieval in ejaculate
finding sperms in the ejaculate
Time frame: 6 months follow-up
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Apr 2020, 15 months.
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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