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

Non Obstructive Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247723
• Other study ID #: SIVCA
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 20, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The needle was withdrawn and the catheter introduced into the testicular tissue.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 20, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 52 Years

Eligibility

Inclusion Criteria:

• Non Obstructive Azoospermia

• Normal Sized testes (Above 12ml in volume)

Exclusion Criteria:

• Obstructive Azoospermia

• Small sized testes

Related Conditions & MeSH terms

• Azoospermia
• Non Obstructive Azoospermia

Intervention

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.

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight of Testicular Tissue Retrieval	If more than 0.3 grams of testicular tissue could be adequately collected from the procedure	Intraoperative
Secondary	Sperm Retrieval Rate	If Sperm could be found in the collected testicular tissue sample, either aspirated or surgically extracted	Intraoperative