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OpenTrials
Completed

NCT Number: NCT05247723

Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique

Study question:

Can enough testicular tissue be aspirated for sperm retrieval in non-obstructive azoospermia (NOA), using a wide bore 14-G Standard IV cannula in comparison to micro-TESE?

Summary answer:

Standard IV cannula Aspiration (SIVCA) can yield an ample amount of testicular tissue sufficient for sperm retrieval through a single puncture site on the scrotum.

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Key information

Age range

22 year–52 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

What is known already:

The current conventional method of testicular sperm aspiration is fine needle aspiration (FNA). FNA has the advantage of being a cost-effective and minimally invasive procedure compared to open testicular sperm extraction (TESE). But FNA with its conventional 23-G needle may not always yield enough testicular tissue for sperm retrieval. Furthermore, FNA may require multiple punctures on the scrotum to retrieve enough tissues from different areas of the testis.

Study design, size, duration:

A 24 months prospective cohort study conducted at a specialized IVF center. A total of 130 men aged from 22 to 53 years old (35.03 +/- 9.04) with NOA and normal testicular volume (≥ 12ml) were enrolled in the study. The men had testicular biopsies taken at the day of their partners' ovum pick-up. On each patient, the testes were randomized to undergo SIVCA on one testis followed by micro-TESE on the contralateral testis.

Participants/materials, setting, methods:

After local anesthesia, a wide bore 14-G standard IV cannula was introduced near the lower pole of the testis. The needle was withdrawn and the catheter introduced into the testicular tissue. A 20-ml syringe was secured to the catheter and constant negative pressure applied and secured with a clamp. Back and forth motions were performed covering as many areas of the testis as possible. Micro-TESE was then performed on the contralateral testis.Sperm retrieval rates (SRR) will be compared between the two techniques using McNemar χ2 test. A P-value of less than 0.05 was considered to be statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non Obstructive Azoospermia
  • Normal Sized testes (Above 12ml in volume)

Exclusion criteria

  • Obstructive Azoospermia
  • Small sized testes

Treatment and study plan

Standard IV Cannula for aspiration of testicular sperm

Device

After local anesthesia, a wide bore 14-G standard IV cannula was introduced near the lower pole of the testis. The needle was withdrawn and the catheter introduced into the testicular tissue. A 20-ml syringe was secured to the catheter and constant negative pressure applied and secured with a clamp. Back and forth motions were performed covering as many areas of the testis as possible.

Micro-TESE

Procedure

Conventional Microscopic Testicular Sperm Extraction (Micro-TESE), Open Testicular Biopsy using surgical Microscope

Primary outcomes

  1. Weight of Testicular Tissue Retrieval

    Time frame: Intraoperative

    If more than 0.3 grams of testicular tissue could be adequately collected from the procedure

Secondary outcomes

  1. Sperm Retrieval Rate

    Time frame: Intraoperative

    If Sperm could be found in the collected testicular tissue sample, either aspirated or surgically extracted

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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