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

Primary Purpose

Non Obstructive Azoospermia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Standard IV Cannula for aspiration of testicular sperm
Micro-TESE
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Obstructive Azoospermia focused on measuring Non Obstructive Azoospermia, Fine Needle Aspiration, Micro-TESE

Eligibility Criteria

22 Years - 52 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Obstructive Azoospermia
  • Small sized testes

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SIVCA

Micro-TESE

Arm Description

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

Extracting testicular tissue surgically

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2022
Last Updated
March 8, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05247723
Brief Title
Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique
Official Title
Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Obstructive Azoospermia
Keywords
Non Obstructive Azoospermia, Fine Needle Aspiration, Micro-TESE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIVCA
Arm Type
Experimental
Arm Description
Aspirating testicular tissue using a standard IV cannula with applied negative pressure.
Arm Title
Micro-TESE
Arm Type
Active Comparator
Arm Description
Extracting testicular tissue surgically
Intervention Type
Device
Intervention Name(s)
Standard IV Cannula for aspiration of testicular sperm
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Micro-TESE
Intervention Description
Conventional Microscopic Testicular Sperm Extraction (Micro-TESE), Open Testicular Biopsy using surgical Microscope
Primary Outcome Measure Information:
Title
Weight of Testicular Tissue Retrieval
Description
If more than 0.3 grams of testicular tissue could be adequately collected from the procedure
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Sperm Retrieval Rate
Description
If Sperm could be found in the collected testicular tissue sample, either aspirated or surgically extracted
Time Frame
Intraoperative

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non Obstructive Azoospermia Normal Sized testes (Above 12ml in volume) Exclusion Criteria: Obstructive Azoospermia Small sized testes
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD collected during the trial after deidentification, beginning 9 months and ending 36 months after publication
IPD Sharing Time Frame
Data will be available upon reasonable request

Learn more about this trial

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

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