Klinefelter SyndromeNCT02414295
Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection
A study testing Mesenchymal stem cell injection in people with Klinefelter Syndrome and Azoospermia, run by Man Clinic for Andrology, Male Infertility and Sexual Dysfunction at 1 site in Egypt.
Trial summary
Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical findings are nonspecific during childhood; thus, the diagnosis commonly is made during adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism and gynecomastia. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Klinefelter Syndrome, Azoospermia
- What is being tested?
- Mesenchymal stem cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2013to Aug 2014
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Kleinfelter syndrome
- Azoospermia
- Negative TESE
Who cannot join
- Absent Testes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection
Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical findings are nonspecific during childhood; thus, the diagnosis commonly is made during adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.
Approximately one in 1,000 boys is born with an additional X chromosome-47,XXY, the karyotype that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of male infertility.
Read more
Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10 percent).
Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count. If sperm are present, cryopreservation is useful for future family planning with intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued. Although there have been multiple reports of successful fertilization by men with Klinefelter syndrome.
Mesenchymal stem cell injection in testicular tubules and intra testicular artery using surgical microscope.
The period for follow up last from three months to twelve months including semen analysis to detect sperm and hormonal profile .
Read the detailed description
The problem started with this kind of patinets when underwent multiple TESE without sperm.
The investigators try to inject KS patients with mesenchymal stem cells to stimulate testicular tissue for production of sperms.
before injection the investigators measure:( FSH, LH, Testosterone, Prolactin, Inhibin B, Karyotyping, Azoospermic Factor, Testicular size by ultrasound).
Three to twelf months after stem cell injection the investigators reevaluate patients by the same measure to demoenstarte any changes.
- Conditions
- Klinefelter Syndrome, Azoospermia
- Being tested
- Mesenchymal stem cell injection
- Keywords
- Stem cell, Kleinfelter syndrome, Azoospermia, Sterility, Infertility
- Medical subject headings
- Klinefelter Syndrome, Azoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell injectionDrug
Aspirated bone marrow then separation for Mesenchymal stem cell
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell injection | Experimental | Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery Receives: Drug: Mesenchymal stem cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm detection
Semen Analysis
Measured: 12 months
Secondary outcomes (1)
Hormonal profile
Inhibine B, FSH, LH
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klinefelter SyndromeStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled A Gadalla, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414295
- Sponsor's protocol ID
- 6714
- Status last verified
- Apr 2015
- First submitted
- 21 Aug 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection
- ClinicalTrials.gov ID
- NCT02414295
- Acronym / sponsor ID
- 6714
- Conditions
- Klinefelter Syndrome, Azoospermia
- Keywords
- Stem cell, Kleinfelter syndrome, Azoospermia, Sterility, Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Man Clinic for Andrology, Male Infertility and Sexual DysfunctionUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Apr 2015 (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.
Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical findings are nonspecific during childhood; thus, the diagnosis commonly is made during adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.
Approximately one in 1,000 boys is born with an additional X chromosome-47,XXY, the karyotype that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of male infertility.
Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10 percent).
Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count. If sperm are present, cryopreservation is useful for future family planning with intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued. Although there have been multiple reports of successful fertilization by men with Klinefelter syndrome.
Mesenchymal stem cell injection in testicular tubules and intra testicular artery using surgical microscope.
The period for follow up last from three months to twelve months including semen analysis to detect sperm and hormonal profile .
Detailed description
The problem started with this kind of patinets when underwent multiple TESE without sperm.
The investigators try to inject KS patients with mesenchymal stem cells to stimulate testicular tissue for production of sperms.
before injection the investigators measure:( FSH, LH, Testosterone, Prolactin, Inhibin B, Karyotyping, Azoospermic Factor, Testicular size by ultrasound).
Three to twelf months after stem cell injection the investigators reevaluate patients by the same measure to demoenstarte any changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell injection | Experimental | Drug: Mesenchymal stem cell injectionBone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Kleinfelter syndrome
- Azoospermia
- Negative TESE
Key exclusion criteria (1 listed)
- Absent 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 |
|---|---|---|
| Mesenchymal stem cell injectionAspirated bone marrow then separation for Mesenchymal stem cell | Drug | Mesenchymal stem cell injection |
Primary outcome
Sperm detection
Time frame: 12 months
Semen Analysis
1 secondary outcome
Hormonal profile
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal stem cell injection in people with Klinefelter Syndrome and 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 3 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: finished, as of the sponsor's last update on 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm detection (time frame: 12 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 10 Apr 2015.