AzoospermiaNCT02008799
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
A study testing Bone marrow stem cell injection in people with Azoospermia, run by Man Clinic for Andrology, Male Infertility and Sexual Dysfunction at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Azoospermia
- What is being tested?
- Bone marrow stem cell injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Azoospermia
Who cannot join
- Absent or surgical removed testes
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Man Clinic
Cairo, 33611
Khaled A Gadalla, MD, 20222725025, Khaledgadalla@gmail.com
Khaled A Gadalla, MD
About this study
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
- Conditions
- Azoospermia
- Being tested
- Bone marrow stem cell injection
- Keywords
- Stem cell, infertility, Azoospermia
- Medical subject headings
- Azoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow stem cell injectionProcedure or surgery
Injection should be in testis and testicular artery
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow stem cell injection | Experimental | through special butterfly inject stem cell in testicular artery and inside tubules Receives: Procedure: Bone marrow stem cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen Analysis
After stem cell injection by three to six months we evaluate the outcome by semen analysis
Measured: Three to six months
Secondary outcomes (1)
Inhibin B Hormone
If semen analysis still azoo we do Inhibin B Hormone
Measured: Three to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AzoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
- Investigators
- Khaled A Gadalla, MD, Principal investigator, Man Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008799
- Sponsor's protocol ID
- SCA2013
- Status last verified
- Apr 2015
- First submitted
- 8 Dec 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
- ClinicalTrials.gov ID
- NCT02008799
- Acronym / sponsor ID
- SCA2013
- Conditions
- Azoospermia
- Keywords
- Stem cell, infertility, Azoospermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Man Clinic for Andrology, Male Infertility and Sexual DysfunctionUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow stem cell injection | Experimental | Procedure: Bone marrow stem cell injectionthrough special butterfly inject stem cell in testicular artery and inside tubules |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Azoospermia
Key exclusion criteria (1 listed)
- Absent or surgical removed testes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow stem cell injectionInjection should be in testis and testicular artery | Procedure or surgery | Bone marrow stem cell injection |
Primary outcome
Semen Analysis
Time frame: Three to six months
After stem cell injection by three to six months we evaluate the outcome by semen analysis
1 secondary outcome
Inhibin B Hormone
Time frame: Three to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
Related trials for Azoospermia
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
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A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
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Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
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Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.
Non-obstructive Azoospermia
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled A Gadalla, MD principal investigator
Man Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow stem cell injection in people with Azoospermia, run by Man Clinic for Andrology, Male Infertility and Sexual Dysfunction at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled A Gadalla, MD (20222725025, Khaledgadalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen Analysis (time frame: Three to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.