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Testis Needle Aspiration of Sperm in Men With Azoospermia

Primary Purpose

Azoospermia

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Sperm cell aspiration and TEFNA
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Azoospermia focused on measuring Azoospermia, Rete Testis, TEFNA

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men with Obstructive/Non-Obstructive Azoospermia who turned to sperm cell aspiration for IVF and were found suitable for TEFNA and signed consent form.

Exclusion Criteria:

  • healthy, non-azoospermic men
  • men who are unsuitable for the TEFNA procedure
  • men who don't sign the Informed Consent

Sites / Locations

  • Hadassah University Medical Center, Ein KeremRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Men with Azoospermia, sperm cell aspiration and TEFNA

Arm Description

Men between 16-80 with Obstructive and Non-Obstructive Azoospermia; Sperm cell aspiration,TEFNA and Ultrasound Guidance

Outcomes

Primary Outcome Measures

Ultrasound Guidance of Sperm Aspiration to Improve Efficiency of TEFNA
The efficiency will be assessed by the percentage of participants in which at least one sperm cell will be successfully retrieved from ultrasound-guided Rete-Testis aspiration. The efficiency will be calculated separately for participants with Obstructive- and non-Obstructive Azoospermia.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2015
Last Updated
February 15, 2023
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02418832
Brief Title
Testis Needle Aspiration of Sperm in Men With Azoospermia
Official Title
Rete Testis Needle Aspiration for Retrieval of Sperm in Men With Azoospermia Using Ultrasound Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Needle aspiration of the epididymis causes rupture and irreversible damage to the duct. Recurring punctures and needle aspirations of fluid and tissue during Testicular Fine Needle Aspiration (TEFNA) procedure cause irreparable injury and loss of part of the testis' tubules. The hypothesis of this research is that production of sperm from the testis will be improved due to ultrasonically guided Rete Testis needle aspiration. In cases of Obstructive Azoospermia, the Rete Testis is expected to contain a large number of sperm cells. In cases of Non-Obstructive Azoospermia, the investigators can expect to produce sperm cells from aspiration of the Rete Testis, which drains all of the testis' tubules. Furthermore, catheterization of the Rete Testis will allow for the drainage of all testes tubules and for the production of sperm cells created locally in some of the tubules or in parts of them. The potential advantage of needle aspiration from the Rete Testis is that the procedure will allow for the aspiration from all the testes tubules, as opposed to the standard method of sperm cells production from the testis which samples only some of the tubules. Therefore, it is expected that the procedure suggested in this research will be more efficient than the standard procedures currently in practice. An additional advantage to this procedure is that puncture and aspiration of the tubule network is not expected to block the drainage from the testis, as is the case in aspiration of the epididymis, and it is also not expected to damage the tubules, as is the case in TEFNA and in TESE.
Detailed Description
Potential subjects will be Azoospermic men who turn to the IVF unit at Hadassah Ein Kerem and are candidates for a TEFNA treatment. Only after the men will receive an explanation of the TEFNA procedure and sign a consent form for TEFNA will they be invited to join the study. After an explanation, the men will sign a consent form (attached) for participation in the study. The TEFNA procedure in each testis will begin with an ultrasonically guided Rete Testis needle aspiration and washing of the testes tubules. A PP Spinal Needle, of 20-27 Gage and 90mm length, will be used for the ultrasonically guided puncture of the testis and catheterization of the Rete Testis network. After the catheterization, there will be an aspiration, followed by the washing of the testis tubule network in saline used for IV, in a volume of up to 1mL (5), using a 1mL syringe. In men with Obstructive Azoospermia, in case the samples aspirated from the Rete Testis will contain many motile sperm cells (more than hundreds), there will be no need for a TEFNA procedure. In cases where an initial sample of the Rete Testis aspiration will not show many motile sperm cells, the TEFNA procedure will continue on as planned. The samples from the Rete Testis aspiration will be separately checked for sperm cells from the sample and tissue produced from the TEFNA procedure. The sperm cells produced from the Rete Testis will be used for cryopreservation or fertilization of the ovum of the patient's partner, as is customary in sperm cells attained through the TEFNA procedure. Should sperm cells be produced both from the Rete Testis and from the epididymis or testes, the partner's ovum will be fertilized by the highest quality sperm cells of both sources. Clinical follow-up on patients will be conducted as customary after testis aspiration. The patients will be invited six months after the procedure for an ultrasonic check-up of the testes and the Rete Testis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia
Keywords
Azoospermia, Rete Testis, TEFNA

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Men with Azoospermia, sperm cell aspiration and TEFNA
Arm Type
Other
Arm Description
Men between 16-80 with Obstructive and Non-Obstructive Azoospermia; Sperm cell aspiration,TEFNA and Ultrasound Guidance
Intervention Type
Procedure
Intervention Name(s)
Sperm cell aspiration and TEFNA
Intervention Description
Testicular Fine Needle Aspiration (TEFNA)
Primary Outcome Measure Information:
Title
Ultrasound Guidance of Sperm Aspiration to Improve Efficiency of TEFNA
Description
The efficiency will be assessed by the percentage of participants in which at least one sperm cell will be successfully retrieved from ultrasound-guided Rete-Testis aspiration. The efficiency will be calculated separately for participants with Obstructive- and non-Obstructive Azoospermia.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men with Obstructive/Non-Obstructive Azoospermia who turned to sperm cell aspiration for IVF and were found suitable for TEFNA and signed consent form. Exclusion Criteria: healthy, non-azoospermic men men who are unsuitable for the TEFNA procedure men who don't sign the Informed Consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin E. Reubinoff, MD PhD
Phone
972-2-677-7485
Email
benjaminr@ekmd.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly E. Tannenbaum, MSQA
Phone
972-572-2014
Email
stannenbaum@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin E. Reubinoff, MD PhD
Organizational Affiliation
Hadassah University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Medical Center, Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamen E Reubinoff, MD PhD
Phone
02-677-7947
Email
stannenbaum@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Shelly E. Tannenbaum, MSQA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11446872
Citation
Schoysman R, Van Roosendaal E, Bollen N, Vandervorst M, Vanderzwalmen P, Standaert V, Berting G, Debauche C, Lefere C. Modern sperm retrieval techniques and their usefulness in oocyte fertilization. BJU Int. 2001 Jul;88(2):141-6. doi: 10.1046/j.1464-410x.2001.02301.x. No abstract available.
Results Reference
background
PubMed Identifier
10402390
Citation
Lewin A, Reubinoff B, Porat-Katz A, Weiss D, Eisenberg V, Arbel R, Bar-el H, Safran A. Testicular fine needle aspiration: the alternative method for sperm retrieval in non-obstructive azoospermia. Hum Reprod. 1999 Jul;14(7):1785-90. doi: 10.1093/humrep/14.7.1785.
Results Reference
background
PubMed Identifier
9262283
Citation
Friedler S, Raziel A, Strassburger D, Soffer Y, Komarovsky D, Ron-El R. Testicular sperm retrieval by percutaneous fine needle sperm aspiration compared with testicular sperm extraction by open biopsy in men with non-obstructive azoospermia. Hum Reprod. 1997 Jul;12(7):1488-93. doi: 10.1093/humrep/12.7.1488.
Results Reference
background
PubMed Identifier
10374111
Citation
Schlatt S, Rosiepen G, Weinbauer GF, Rolf C, Brook PF, Nieschlag E. Germ cell transfer into rat, bovine, monkey and human testes. Hum Reprod. 1999 Jan;14(1):144-50. doi: 10.1093/humrep/14.1.144.
Results Reference
background
PubMed Identifier
23122294
Citation
Hermann BP, Sukhwani M, Winkler F, Pascarella JN, Peters KA, Sheng Y, Valli H, Rodriguez M, Ezzelarab M, Dargo G, Peterson K, Masterson K, Ramsey C, Ward T, Lienesch M, Volk A, Cooper DK, Thomson AW, Kiss JE, Penedo MC, Schatten GP, Mitalipov S, Orwig KE. Spermatogonial stem cell transplantation into rhesus testes regenerates spermatogenesis producing functional sperm. Cell Stem Cell. 2012 Nov 2;11(5):715-26. doi: 10.1016/j.stem.2012.07.017.
Results Reference
background

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Testis Needle Aspiration of Sperm in Men With Azoospermia

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