NCT02418832 Testis Needle Aspiration of Sperm in Men With Azoospermia
| NCT ID | NCT02418832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hadassah Medical Organization |
| Condition | Azoospermia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-07-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2018-07-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Benjamin E. Reubinoff, MD PhD
PRINCIPAL INVESTIGATOR
Hadassah University Medical Center
Frequently Asked Questions
Who can join the NCT02418832 clinical trial?
This trial is open to male participants only, aged 16 Years or older, up to 80 Years, studying Azoospermia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02418832 currently recruiting?
Yes, NCT02418832 is actively recruiting participants. Contact the research team at benjaminr@ekmd.huji.ac.il for enrollment information.
Where is the NCT02418832 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT02418832 clinical trial?
NCT02418832 is sponsored by Hadassah Medical Organization. The principal investigator is Benjamin E. Reubinoff, MD PhD at Hadassah University Medical Center. The trial plans to enroll 150 participants.