NCT02008799

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

December 8, 2013

Last Update Submit

April 7, 2015

Conditions

Azoospermia

Keywords

Stem cell, infertility, Azoospermia

Outcome Measures

Primary Outcomes (1)

  • Semen Analysis

    After stem cell injection by three to six months we evaluate the outcome by semen analysis

    Three to six months

Secondary Outcomes (1)

  • Inhibin B Hormone

    Three to six months

Study Arms (1)

Bone marrow stem cell injection

EXPERIMENTAL

through special butterfly inject stem cell in testicular artery and inside tubules

Procedure: Bone marrow stem cell injection

Interventions

Bone marrow stem cell injectionPROCEDURE

Injection should be in testis and testicular artery

Bone marrow stem cell injection

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Azoospermia

You may not qualify if:

  • \- Absent or surgical removed testes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Man Clinic

Cairo, 33611, Egypt

RECRUITING

MeSH Terms

Conditions

AzoospermiaInfertility

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Khaled A Gadalla, MD

    Man Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled A Gadalla, MD

CONTACT

20222725025Khaledgadalla@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 11, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)