NCT04397887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

May 7, 2020

Last Update Submit

May 18, 2020

Conditions

Azoospermia, NonobstructiveVaricocele

Keywords

VaricoceleAzoospermiaTEX 101

Outcome Measures

Primary Outcomes (2)

  • Sperm retrieval in ejaculate

    finding sperms in the ejaculate

    3 months follow-up

  • Sperm retrieval in ejaculate

    finding sperms in the ejaculate

    6 months follow-up

Study Arms (1)

Men with Azoospermia and varicocele

EXPERIMENTAL

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

Interventions

micro-surgical varicocelectomyPROCEDURE

Sub-inguinal micro-surgical varicocelectomy

Men with Azoospermia and varicocele

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Azoospermia in at least 2 separate semen analyses
  • Palpable varicocele

You may not qualify if:

  • Obstructive azoospermia
  • Abnormal Karyotype
  • Previous chemotherapy, radiotherapy and or diagnosed maligancy.
  • previous testicular of inguinal surgeries.
  • secondary azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrology department, Faculty of Medicine - Cairo University

Cairo, 12622, Egypt

Location

MeSH Terms

Conditions

Azoospermia, NonobstructiveVaricoceleAzoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesInfertility, MaleInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrology consultant/ lecturer

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 21, 2020

Study Start

January 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)