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

Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02008799
• Other study ID #: SCA2013
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2013
• Last updated: April 7, 2015
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
• Contact: Khaled A Gadalla, MD
• Phone: 20222725025
• Email: Khaledgadalla[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Azoospermia

Exclusion Criteria:

• Absent or surgical removed testes

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia

Intervention

Procedure:
• Bone marrow stem cell injection
Injection should be in testis and testicular artery

Locations

Country	Name	City	State
Egypt	Man Clinic	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semen Analysis	After stem cell injection by three to six months we evaluate the outcome by semen analysis	Three to six months	No
Secondary	Inhibin B Hormone	If semen analysis still azoo we do Inhibin B Hormone	Three to six months	No