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OpenTrials
Completed

NCT Number: NCT04397887

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

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.

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Key information

Conditions

Azoospermia, Nonobstructive Azoospermia Cardiovascular Diseases Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases Varicocele Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Andrology department, Faculty of Medicine - Cairo University

Cairo, 12622, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

micro-surgical varicocelectomy

Procedure

Sub-inguinal micro-surgical varicocelectomy

Primary outcomes

  1. Sperm retrieval in ejaculate

    Time frame: 3 months follow-up

    finding sperms in the ejaculate

  2. Sperm retrieval in ejaculate

    Time frame: 6 months follow-up

    finding sperms in the ejaculate

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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