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

Not Applicable

Completed

• Conditions: Non Obstructive Azoospermia
• Interventions: Procedure: Micro-TESE; Device: Standard IV Cannula for aspiration of testicular sperm

• Registration Number: NCT05247723
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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 The needle was withdrawn and the catheter introduced into the testicular tissue.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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-20
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

• Obstructive Azoospermia
• Small sized testes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIVCA	Micro-TESE	Aspirating testicular tissue using a standard IV cannula with applied negative pressure.
Micro-TESE	Standard IV Cannula for aspiration of testicular sperm	Extracting testicular tissue surgically

Primary Outcome Measures

Name	Time	Method
Weight of Testicular Tissue Retrieval	Intraoperative	If more than 0.3 grams of testicular tissue could be adequately collected from the procedure

Secondary Outcome Measures

Name	Time	Method
Sperm Retrieval Rate	Intraoperative	If Sperm could be found in the collected testicular tissue sample, either aspirated or surgically extracted

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt