OligozoospermiaNCT02617173
The Effect of Low Electrical Current on Testicular Spermatocyte Count
A study testing Micro 400 Matrix Therapy Products in people with Oligozoospermia and Azoospermia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Oligozoospermia, refers to a low concentration of sperm. A low sperm count or poor sperm quality is the cause of infertility in about 20% of couples with fertility problems, and a contributory factor in a further 25% of couples. In the majority of cases, no cause can be found. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men only
- Conditions the study is for
- Oligozoospermia, Azoospermia
- What is being tested?
- Micro 400 Matrix Therapy Products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Jan 2017
- 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 21 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men with primary infertility defined as a state of Azoospermia.
- Men with pathological sperm tests indices as defined by the WHO.
Who cannot join
- Men with genetic syndromes, and states of Azoospermia secondary to chemotherapy, bone marrow transplantation or radiation.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Male Fertility Clinic, Sheba Medical Center
Ramat Gan, 5265601
Gil Raviv, Prof, 972-52-666-8285, Gil.Raviv@sheba.health.gov.il
David Shashar, Dr
About this study
Oligozoospermia, refers to a low concentration of sperm. A low sperm count or poor sperm quality is the cause of infertility in about 20% of couples with fertility problems, and a contributory factor in a further 25% of couples. In the majority of cases, no cause can be found. For mild male infertility, intra uterine insemination (IUI) is the procedure of choice with a pregnancy rate of 6.5%. In IUI, sperm is inserted using a thin, flexible catheter directly into a woman's uterus.
Azoospermia affects 1% of the male population and 20% of male infertility situations. Over 50% of azoospermic cases are due to testicular failure, including absence or failed production as well as low production and maturation arrest during the process of spermatogenesis. ICSI allows successful fertilization even with immature sperm obtained directly from testicular tissue. This is done through TESA (Testicular sperm aspiration) or TESE (Testicular sperm extraction). In cases of TESE small strips of testicular tissue are extracted with the intention of finding few viable sperm cells to be used for IVF or ICSI. Men with non-obstructive azoospermia have 0 to 3 mature spermatids per seminiferous tubule in contrast to 17-35 mature spermatids in men with normal spermatogenesis. TESE success rates are approximately 50% but differ according to etiology. Unfortunately, there is no method of pointing out where sperm may be found. TESE is accompanied with pain, tissue loss, reduced success in future TESE due to tissue scaring and testosterone deficiency.
Read more
The complex process of spermatogenesis includes maturation of young spermatids into spermatozoas, a process which takes approximately 74 days. During spermatogenesis, spermatogonial stem cells are transformed into spermatids and released from the seminiferous tubule epithelium into its lumen. Non-motile spermatozoa are transported through the seminifreous tubules to the epididymis by testicular fluid secreted from the Sertoli cells with the aid of peristaltic contraction. During transport through the epididymis, sperm cells develop the ability to progress forward, undergo capacitation and attach and penetrate the egg.
The electric charge of the spermatic cell has been termed zeta potential (electrokinetic potential) and is defined as the electric potential in the slip plane between the sperm membrane and its surroundings. Mature sperm possess an electric charge of -16 to -20 mV.
In the animal study conducted, positive electrical current with a low amplitude bellow sensation level was situated around the scrotum of four normospermic and one oligospermic male pigs. At the end of the research the concentration of spermatocytes in the epididymis obtained in surgery was found to be 200 to 1600 percent above the baseline.
Our intention is to evaluate if positive electrical current with a low amplitude bellow sensation level situated on the scrotum will increase the concentration of spermatocytes in the ejaculate.
If our hypothesis is confirmed this may become a method for treating male infertility. The period of improvement is still unclear.
- Conditions
- Oligozoospermia, Azoospermia
- Being tested
- Micro 400 Matrix Therapy Products
- Medical subject headings
- Oligospermia, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro 400 Matrix Therapy ProductsDevice
Positive electrical current with a low amplitude bellow sensation level situated on the scrotum.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical nerve stimulation | Experimental | Low current electrical stimulator Receives: Device: Micro 400 Matrix Therapy Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spermatomcyte count in the ejaculate.
To evaluate if positive electrical current with a low amplitude below sensation level situated on the scrotum will increase the concentration of spermatocytes in the ejaculate.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OligozoospermiaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gil Raviv, Prof, Principal investigator, Urology Department, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617173
- Sponsor's protocol ID
- SHEBA-15-2514-GR-CTIL
- Status last verified
- Nov 2015
- First submitted
- 22 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ishijima SA, Okuno M, Mohri H. Zeta potential of human X- and Y-bearing sperm. Int J Androl. 1991 Oct;14(5):340-7. doi: 10.1111/j.1365-2605.1991.tb01102.x.
PubMed 1794918Chan PJ, Jacobson JD, Corselli JU, Patton WC. A simple zeta method for sperm selection based on membrane charge. Fertil Steril. 2006 Feb;85(2):481-6. doi: 10.1016/j.fertnstert.2005.07.1302.
PubMed 16595231
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Electrical Current on Testicular Spermatocyte Count
- ClinicalTrials.gov ID
- NCT02617173
- Acronym / sponsor ID
- SHEBA-15-2514-GR-CTIL
- Conditions
- Oligozoospermia, Azoospermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 30 Nov 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.
Oligozoospermia, refers to a low concentration of sperm. A low sperm count or poor sperm quality is the cause of infertility in about 20% of couples with fertility problems, and a contributory factor in a further 25% of couples. In the majority of cases, no cause can be found. For mild male infertility, intra uterine insemination (IUI) is the procedure of choice with a pregnancy rate of 6.5%. In IUI, sperm is inserted using a thin, flexible catheter directly into a woman's uterus.
Azoospermia affects 1% of the male population and 20% of male infertility situations. Over 50% of azoospermic cases are due to testicular failure, including absence or failed production as well as low production and maturation arrest during the process of spermatogenesis. ICSI allows successful fertilization even with immature sperm obtained directly from testicular tissue. This is done through TESA (Testicular sperm aspiration) or TESE (Testicular sperm extraction). In cases of TESE small strips of testicular tissue are extracted with the intention of finding few viable sperm cells to be used for IVF or ICSI. Men with non-obstructive azoospermia have 0 to 3 mature spermatids per seminiferous tubule in contrast to 17-35 mature spermatids in men with normal spermatogenesis. TESE success rates are approximately 50% but differ according to etiology. Unfortunately, there is no method of pointing out where sperm may be found. TESE is accompanied with pain, tissue loss, reduced success in future TESE due to tissue scaring and testosterone deficiency.
The complex process of spermatogenesis includes maturation of young spermatids into spermatozoas, a process which takes approximately 74 days. During spermatogenesis, spermatogonial stem cells are transformed into spermatids and released from the seminiferous tubule epithelium into its lumen. Non-motile spermatozoa are transported through the seminifreous tubules to the epididymis by testicular fluid secreted from the Sertoli cells with the aid of peristaltic contraction. During transport through the epididymis, sperm cells develop the ability to progress forward, undergo capacitation and attach and penetrate the egg.
The electric charge of the spermatic cell has been termed zeta potential (electrokinetic potential) and is defined as the electric potential in the slip plane between the sperm membrane and its surroundings. Mature sperm possess an electric charge of -16 to -20 mV.
In the animal study conducted, positive electrical current with a low amplitude bellow sensation level was situated around the scrotum of four normospermic and one oligospermic male pigs. At the end of the research the concentration of spermatocytes in the epididymis obtained in surgery was found to be 200 to 1600 percent above the baseline.
Our intention is to evaluate if positive electrical current with a low amplitude bellow sensation level situated on the scrotum will increase the concentration of spermatocytes in the ejaculate.
If our hypothesis is confirmed this may become a method for treating male infertility. The period of improvement is still unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation | Experimental | Device: Micro 400 Matrix Therapy ProductsLow current electrical stimulator |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men with primary infertility defined as a state of Azoospermia.
- Men with pathological sperm tests indices as defined by the WHO.
Key exclusion criteria (1 listed)
- Men with genetic syndromes, and states of Azoospermia secondary to chemotherapy, bone marrow transplantation or radiation.
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 |
|---|---|---|
| Micro 400 Matrix Therapy ProductsPositive electrical current with a low amplitude bellow sensation level situated on the scrotum. | Device | Transcutaneous electrical nerve stimulation |
Primary outcome
Spermatomcyte count in the ejaculate.
Time frame: One year.
To evaluate if positive electrical current with a low amplitude below sensation level situated on the scrotum will increase the concentration of spermatocytes in the ejaculate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Results publication: PubMed 1794918Ishijima SA, Okuno M, Mohri H. Zeta potential of human X- and Y-bearing sperm. Int J Androl. 1991 Oct;14(5):340-7. doi: 10.1111/j.1365-2605.1991.tb01102.x.
- Results publication: PubMed 16595231Chan PJ, Jacobson JD, Corselli JU, Patton WC. A simple zeta method for sperm selection based on membrane charge. Fertil Steril. 2006 Feb;85(2):481-6. doi: 10.1016/j.fertnstert.2005.07.1302.
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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.
Gil Raviv, Prof principal investigator
Urology Department, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro 400 Matrix Therapy Products in people with Oligozoospermia and Azoospermia, run by Sheba Medical Center at 1 site in Israel.
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 2 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 30 Nov 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 Israel. 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 Gil Raviv, Prof (972-52-666-8285, Gil.Raviv@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spermatomcyte count in the ejaculate. (time frame: One year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617173, which also lists 2 linked publications.
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 30 Nov 2015.