Clinical trial NCT05247723: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non Obstructive Azoospermia
Keywords: Non Obstructive Azoospermia
Fine Needle Aspiration
Micro-TESE
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 130
Sex: MALE
Minimum age (years): 22
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Obstructive Azoospermia
* Small sized testes

Primary outcomes:
measure: Weight of Testicular Tissue Retrieval
timeFrame: Intraoperative
Secondary outcomes:
measure: Sperm Retrieval Rate
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: