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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04397887
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
15.9
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: micro-surgical varicocelectomy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Procedure: micro-surgical varicocelectomy
Sub-inguinal micro-surgical varicocelectomy

Outcome Measures

Primary Outcome Measures

  1. Sperm retrieval in ejaculate [3 months follow-up]

    finding sperms in the ejaculate

  2. Sperm retrieval in ejaculate [6 months follow-up]

    finding sperms in the ejaculate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andrology department, Faculty of Medicine - Cairo University Cairo Egypt 12622

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Wael Ragab, Andrology consultant/ lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT04397887
Other Study ID Numbers:
  • CairoU Azoospermia Vx TEX101
First Posted:
May 21, 2020
Last Update Posted:
May 21, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Wael Ragab, Andrology consultant/ lecturer, Cairo University
Varicocele
Azoospermia
TEX 101
Additional relevant MeSH terms:
Azoospermia
Varicocele

Study Results

No Results Posted as of May 21, 2020