Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia

April 7, 2015 updated by: Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately 1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis. Until recently, it was assumed that men with non-obstructive azoospermia were untreatable. Indeed, these patients were often referred to as being "sterile" or having "testicular failure." We start to use stem cell in treatment of such patients by injecting the stem cell at the testis and the testicular artery in one group and at the testis only in other group

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 33611
        • Recruiting
        • Man Clinic
        • Contact:
        • Principal Investigator:
          • Khaled A Gadalla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

- Azoospermia

Exclusion Criteria:

- Absent or surgical removed testes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone marrow stem cell injection
through special butterfly inject stem cell in testicular artery and inside tubules
Procedure: Bone marrow stem cell injection
Injection should be in testis and testicular artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semen Analysis
Time Frame: Three to six months
After stem cell injection by three to six months we evaluate the outcome by semen analysis
Three to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibin B Hormone
Time Frame: Three to six months
If semen analysis still azoo we do Inhibin B Hormone
Three to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

Investigators

  • Principal Investigator: Khaled A Gadalla, MD, Man Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 8, 2013

First Submitted That Met QC Criteria

December 8, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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