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The Effect of Low Electrical Current on Testicular Spermatocyte Count

Primary Purpose

Oligozoospermia, Azoospermia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Micro 400 Matrix Therapy Products
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligozoospermia

Eligibility Criteria

21 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men with primary infertility defined as a state of Azoospermia.
  • Men with pathological sperm tests indices as defined by the WHO.

Exclusion Criteria:

  • Men with genetic syndromes, and states of Azoospermia secondary to chemotherapy, bone marrow transplantation or radiation.

Sites / Locations

  • Male Fertility Clinic, Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous electrical nerve stimulation

Arm Description

Low current electrical stimulator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 22, 2015
Last Updated
November 26, 2015
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02617173
Brief Title
The Effect of Low Electrical Current on Testicular Spermatocyte Count
Official Title
The Effect of Low Electrical Current on Testicular Spermatocyte Count
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligozoospermia, Azoospermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous electrical nerve stimulation
Arm Type
Experimental
Arm Description
Low current electrical stimulator
Intervention Type
Device
Intervention Name(s)
Micro 400 Matrix Therapy Products
Intervention Description
Positive electrical current with a low amplitude bellow sensation level situated on the scrotum.
Primary Outcome Measure Information:
Title
Spermatomcyte count in the ejaculate.
Description
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.
Time Frame
One year.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men with primary infertility defined as a state of Azoospermia. Men with pathological sperm tests indices as defined by the WHO. Exclusion Criteria: Men with genetic syndromes, and states of Azoospermia secondary to chemotherapy, bone marrow transplantation or radiation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gil Raviv, Prof
Phone
972-52-666-8285
Email
Gil.Raviv@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Raviv, Prof
Organizational Affiliation
Urology Department, Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Male Fertility Clinic, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gil Raviv, Prof
Phone
972-52-666-8285
Email
Gil.Raviv@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
David Shashar, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
1794918
Citation
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.
Results Reference
result
PubMed Identifier
16595231
Citation
Chan 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.
Results Reference
result

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The Effect of Low Electrical Current on Testicular Spermatocyte Count

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