An interventional study of Standard IV Cannula for aspiration of testicular sperm and Micro-TESE in Non Obstructive Azoospermia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 22 Years to 52 Years. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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 The needle was withdrawn and the catheter introduced into the testicular tissue.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.
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's enrollment of 130 is above the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Aspirating testicular tissue using a standard IV cannula with applied negative pressure.
Procedure: 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.
Conventional Microscopic Testicular Sperm Extraction (Micro-TESE), Open Testicular Biopsy using surgical Microscope
Weight of Testicular Tissue Retrieval
If more than 0.3 grams of testicular tissue could be adequately collected from the procedure
Time frame: Intraoperative
Sperm Retrieval Rate
If Sperm could be found in the collected testicular tissue sample, either aspirated or surgically extracted
Time frame: Intraoperative
Plan to share: Yes — All IPD collected during the trial after deidentification, beginning 9 months and ending 36 months after publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available upon reasonable request
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Dec 2021, 35 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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