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

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ClinicalTrials.gov Identifier: NCT02008799
Recruitment Status : Unknown
Verified April 2015 by Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction.
Recruitment status was:  Recruiting
First Posted : December 11, 2013
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

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

Condition or disease Intervention/treatment Phase
Azoospermia Procedure: Bone marrow stem cell injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
Study Start Date : January 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. Semen Analysis [ Time Frame: Three to six months ]
    After stem cell injection by three to six months we evaluate the outcome by semen analysis


Secondary Outcome Measures :
  1. Inhibin B Hormone [ Time Frame: Three to six months ]
    If semen analysis still azoo we do Inhibin B Hormone



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Azoospermia

Exclusion Criteria:

- Absent or surgical removed testes


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008799


Contacts
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Contact: Khaled A Gadalla, MD 20222725025 Khaledgadalla@gmail.com

Locations
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Egypt
Man Clinic Recruiting
Cairo, Egypt, 33611
Contact: Khaled A Gadalla, MD    20222725025    Khaledgadalla@gmail.com   
Principal Investigator: Khaled A Gadalla, MD         
Sponsors and Collaborators
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Investigators
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Principal Investigator: Khaled A Gadalla, MD Man Clinic

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Responsible Party: Khaled Abdulmoneim Gadalla, Prof Dr, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
ClinicalTrials.gov Identifier: NCT02008799    
Other Study ID Numbers: SCA2013
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction:
Stem cell, infertility, Azoospermia
Additional relevant MeSH terms:
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Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male