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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05247723
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.6
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Obstructive Azoospermia	Device: Standard IV Cannula for aspiration of testicular sperm; Procedure: Micro-TESE	N/A

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 The needle was withdrawn and the catheter introduced into the testicular tissue.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

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Jan 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SIVCA Aspirating testicular tissue using a standard IV cannula with applied negative pressure.	Procedure: Micro-TESE; Conventional Microscopic Testicular Sperm Extraction (Micro-TESE), Open Testicular Biopsy using surgical Microscope
Active Comparator: Micro-TESE Extracting testicular tissue surgically	Device: Standard IV Cannula for aspiration of testicular sperm; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Sperm Retrieval Rate [Intraoperative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 52 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Non Obstructive Azoospermia

• Normal Sized testes (Above 12ml in volume)

Exclusion Criteria:

• Obstructive Azoospermia

• Small sized testes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adham ZAAZAA, Associate Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05247723
• Other Study ID Numbers: SIVCA
• First Posted: Feb 21, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Adham ZAAZAA, Associate Professor, Cairo University: Non Obstructive Azoospermia; Fine Needle Aspiration; Micro-TESE
• Additional relevant MeSH terms: Azoospermia

Study Results

No Results Posted as of Mar 22, 2022