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

Cairo University (CU)

Status: Completed

Conditions: Non Obstructive Azoospermia

Treatments: Procedure: Micro-TESE; Device: Standard IV Cannula for aspiration of testicular sperm

Study type: Interventional

Funder types: Other

Identifiers

NCT05247723

SIVCA

Details and patient eligibility

About

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.

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 The needle was withdrawn and the catheter introduced into the testicular tissue.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

Enrollment: 130 patients

Sex: Male

Ages: 22 to 52 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Obstructive Azoospermia
• Small sized testes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

SIVCA

Experimental group

Description:

Aspirating testicular tissue using a standard IV cannula with applied negative pressure.

Treatment:

Procedure: Micro-TESE

Micro-TESE

Active Comparator group

Description:

Extracting testicular tissue surgically

Treatment:

Device: Standard IV Cannula for aspiration of testicular sperm