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Testis Needle Aspiration of Sperm in Men With Azoospermia

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 4, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv19
  2. Minor Study completion date: Dec 31, 2025 to Dec 31, 2030v18
  3. Minor 9 versions Re-verified since Mar 6, 2019, no change to tracked fieldsv9-v17
  4. Notable Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Dec 2022 to Dec 31, 2025
    • Study sites: 0 to 1
    • Study completion date: Dec 2025 to Dec 31, 2025
    • Start date changed from estimate of Jan 2020 to Jul 28, 2018
  5. Notable Start date: Dec 2018 to Jan 2020v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary completion date: Dec 2020 to Dec 2022
    • Start date: Dec 2017 to Dec 2018
    • Study completion date: Dec 2020 to Dec 2025
    v6
  2. Minor 2 versions Re-verified since Nov 23, 2016, no change to tracked fieldsv4-v5
  3. Notable Start date: Nov 2016 to Dec 2017v3
  4. Notable Start date: Sep 2015 to Nov 2016v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02418832
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)
Azoospermia
Related terms Azoospermia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov