AzoospermiaNCT02418832
Testis Needle Aspiration of Sperm in Men With Azoospermia
A study testing Sperm cell aspiration and TEFNA in people with Azoospermia, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years, men only
- Conditions the study is for
- Azoospermia
- What is being tested?
- Sperm cell aspiration and TEFNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Jul 2018to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men with Obstructive/Non-Obstructive Azoospermia who turned to sperm cell aspiration for IVF and were found suitable for TEFNA and signed consent form.
Who cannot join
- healthy, non-azoospermic men
- men who are unsuitable for the TEFNA procedure
- men who don't sign the Informed Consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Medical Center, Ein Kerem
Jerusalem, 9112100
Benjamen E Reubinoff, MD PhD, 02-677-7947, stannenbaum@hadassah.org.il
Shelly E. Tannenbaum, MSQA
About this study
Official title: Rete Testis Needle Aspiration for Retrieval of Sperm in Men With Azoospermia Using Ultrasound Guidance
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.
Read the 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.
- Conditions
- Azoospermia
- Being tested
- Sperm cell aspiration and TEFNA
- Keywords
- Azoospermia, Rete Testis, TEFNA
- Medical subject headings
- Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm cell aspiration and TEFNAProcedure or surgery
Testicular Fine Needle Aspiration (TEFNA)
| Study group | Role | What they receive |
|---|---|---|
| Men with Azoospermia, sperm cell aspiration and TEFNA | Other | Men between 16-80 with Obstructive and Non-Obstructive Azoospermia; Sperm cell aspiration,TEFNA and Ultrasound Guidance Receives: Procedure: Sperm cell aspiration and TEFNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start28 Jul 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AzoospermiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Reubinoff, Hadassah Medical Organization
- Investigators
- Benjamin E. Reubinoff, MD PhD, Principal investigator, Hadassah University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418832
- Sponsor's protocol ID
- 0238-13-HMO
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2015
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11446872Lewin 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.
PubMed 10402390Friedler 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.
PubMed 9262283Schlatt 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.
PubMed 10374111Hermann 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.
PubMed 23122294
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rete Testis Needle Aspiration for Retrieval of Sperm in Men With Azoospermia Using Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT02418832
- Acronym / sponsor ID
- 0238-13-HMO
- Conditions
- Azoospermia
- Keywords
- Azoospermia, Rete Testis, TEFNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with Azoospermia, sperm cell aspiration and TEFNA | Other | Procedure: Sperm cell aspiration and TEFNAMen between 16-80 with Obstructive and Non-Obstructive Azoospermia; Sperm cell aspiration,TEFNA and Ultrasound Guidance |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Men with Obstructive/Non-Obstructive Azoospermia who turned to sperm cell aspiration for IVF and were found suitable for TEFNA and signed consent form.
Key exclusion criteria (3 listed)
- healthy, non-azoospermic men
- men who are unsuitable for the TEFNA procedure
- men who don't sign the Informed Consent
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 |
|---|---|---|
| Sperm cell aspiration and TEFNATesticular Fine Needle Aspiration (TEFNA) | Procedure or surgery | Men with Azoospermia, sperm cell aspiration and TEFNA |
Primary outcome
Ultrasound Guidance of Sperm Aspiration to Improve Efficiency of TEFNA
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 11446872Schoysman 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.
- Background: PubMed 10402390Lewin 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.
- Background: PubMed 9262283Friedler 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.
- Background: PubMed 10374111Schlatt 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.
- Background: PubMed 23122294Hermann 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.
- Individual participant dataSharing planned: No
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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.
Benjamin E. Reubinoff, MD PhD principal investigator
Hadassah University 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 Sperm cell aspiration and TEFNA in people with Azoospermia, run by Hadassah Medical Organization 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin E. Reubinoff, MD PhD (972-2-677-7485, benjaminr@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Guidance of Sperm Aspiration to Improve Efficiency of TEFNA (time frame: 5 years). 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 NCT02418832, which also lists 5 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 4 Mar 2025.