Testis Needle Aspiration of Sperm in Men With Azoospermia
NCT ID: NCT02418832
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2018-07-28
2030-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Men with Azoospermia, sperm cell aspiration and TEFNA
Men between 16-80 with Obstructive and Non-Obstructive Azoospermia; Sperm cell aspiration,TEFNA and Ultrasound Guidance
Sperm cell aspiration and TEFNA
Testicular Fine Needle Aspiration (TEFNA)
Interventions
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Sperm cell aspiration and TEFNA
Testicular Fine Needle Aspiration (TEFNA)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* men who are unsuitable for the TEFNA procedure
* men who don't sign the Informed Consent
16 Years
80 Years
MALE
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Benjamin Reubinoff
Professor, Chairman of the Department of Obstetrics and Gynecology, Hadassah Ein Kerem
Principal Investigators
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Benjamin E. Reubinoff, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hadassah University Medical Center
Locations
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Hadassah University Medical Center, Ein Kerem
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Shelly E. Tannenbaum, MSQA
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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0238-13-HMO
Identifier Type: -
Identifier Source: org_study_id
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