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

NCT05247723 | Completed

• 1 other identifier: SIVCA
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Obstructive Azoospermia

Keywords

Non Obstructive Azoospermia; Fine Needle Aspiration; Micro-TESE

Outcome Measures

Primary Outcomes (1)

• Weight of Testicular Tissue Retrieval

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

  Intraoperative

Secondary Outcomes (1)

• Sperm Retrieval Rate

  Intraoperative

Study Arms (2)

SIVCA

EXPERIMENTAL

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

Procedure: Micro-TESE

Micro-TESE

ACTIVE COMPARATOR

Extracting testicular tissue surgically

Device: Standard IV Cannula for aspiration of testicular sperm

Interventions

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 The needle was withdrawn and the catheter introduced into the testicular tissue.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

Micro-TESE PROCEDURE

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

SIVCA

Eligibility Criteria

• Age: 22 Years - 52 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Obstructive Azoospermia
• Small sized testes

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: On each patient, the testes were randomized to undergo testicular sperm aspiration using a standard IV cannula on one side, followed by surgical microscopic testicular sperm extraction on the contralateral testis.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 21, 2022
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: January 20, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available upon reasonable request

Locations

EG (1)