Testis Needle Aspiration of Sperm in Men With Azoospermia

NCT02418832 | Recruiting

• 1 other identifier: 0238-13-HMO
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Azoospermia

Keywords

Azoospermia; Rete Testis; TEFNA

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (1)

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

Procedure: Sperm cell aspiration and TEFNA

Interventions

Sperm cell aspiration and TEFNA PROCEDURE

Testicular Fine Needle Aspiration (TEFNA)

Men with Azoospermia, sperm cell aspiration and TEFNA

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Medical Center, Ein Kerem

Jerusalem, 9112100, Israel

RECRUITING

Related Publications (5)

• 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.

  PMID: 11446872 BACKGROUND

• 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.

  PMID: 10402390 BACKGROUND

• 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.

  PMID: 9262283 BACKGROUND

• 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.

  PMID: 10374111 BACKGROUND

• 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.

  PMID: 23122294 BACKGROUND

MeSH Terms

Conditions

Azoospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Benjamin E. Reubinoff, MD PhD

  Hadassah University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin E. Reubinoff, MD PhD

CONTACT

972-2-677-7485; benjaminr@ekmd.huji.ac.il

Shelly E. Tannenbaum, MSQA

CONTACT

972-572-2014; stannenbaum@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chairman of the Department of Obstetrics and Gynecology, Hadassah Ein Kerem

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 16, 2015
• Study Start: July 28, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)