Back to resultsIntra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
Primary Purpose
Azoospermia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bone marrow stem cell injection
Sponsored by
About this trial
This is an interventional treatment trial for Azoospermia focused on measuring Stem cell, infertility, Azoospermia
Eligibility Criteria
Inclusion Criteria:
- Azoospermia
Exclusion Criteria:
- Absent or surgical removed testes
Sites / Locations
- Man ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bone marrow stem cell injection
Arm Description
through special butterfly inject stem cell in testicular artery and inside tubules
Outcomes
Primary Outcome Measures
Semen Analysis
After stem cell injection by three to six months we evaluate the outcome by semen analysis
Secondary Outcome Measures
Inhibin B Hormone
If semen analysis still azoo we do Inhibin B Hormone
Full Information
NCT ID
NCT02008799
First Posted
December 8, 2013
Last Updated
April 7, 2015
Sponsor
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
1. Study Identification
Unique Protocol Identification Number
NCT02008799
Brief Title
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
Official Title
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia
Keywords
Stem cell, infertility, Azoospermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bone marrow stem cell injection
Arm Type
Experimental
Arm Description
through special butterfly inject stem cell in testicular artery and inside tubules
Intervention Type
Procedure
Intervention Name(s)
Bone marrow stem cell injection
Intervention Description
Injection should be in testis and testicular artery
Primary Outcome Measure Information:
Title
Semen Analysis
Description
After stem cell injection by three to six months we evaluate the outcome by semen analysis
Time Frame
Three to six months
Secondary Outcome Measure Information:
Title
Inhibin B Hormone
Description
If semen analysis still azoo we do Inhibin B Hormone
Time Frame
Three to six months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Azoospermia
Exclusion Criteria:
- Absent or surgical removed testes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled A Gadalla, MD
Phone
20222725025
Email
Khaledgadalla@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD
Organizational Affiliation
Man Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Man Clinic
City
Cairo
ZIP/Postal Code
33611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD
Phone
20222725025
Email
Khaledgadalla@gmail.com
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD
12. IPD Sharing Statement
Learn more about this trial
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
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