Testis Needle Aspiration of Sperm in Men With Azoospermia

ConditionAzoospermia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age16-80
SponsorHadassah Medical Organization

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

healthy, non-azoospermic men

men who are unsuitable for the TEFNA procedure

men who don't sign the Informed Consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Sperm cell aspiration and TEFNA

    Procedure/Surgery

    Testicular Fine Needle Aspiration (TEFNA)

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Men with Azoospermia, sperm cell aspiration and TEFNAOther 1 intervention

Trial outcomes

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.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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