Non Obstructive AzoospermiaNCT05247723
Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique
A study testing Standard IV Cannula for aspiration of testicular sperm and Micro-TESE in people with Non Obstructive Azoospermia, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 22 to 52 years, men only
- Conditions the study is for
- Non Obstructive Azoospermia
- What is being tested?
- Standard IV Cannula for aspiration of testicular sperm and Micro-TESE
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 52 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Non Obstructive Azoospermia
- Normal Sized testes (Above 12ml in volume)
Who cannot join
- Obstructive Azoospermia
- Small sized testes
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Non Obstructive Azoospermia
- Being tested
- Standard IV Cannula for aspiration of testicular sperm, Micro-TESE
- Keywords
- Non Obstructive Azoospermia, Fine Needle Aspiration, Micro-TESE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard IV Cannula for aspiration of testicular spermDevice
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-TESEProcedure or surgery
Conventional Microscopic Testicular Sperm Extraction (Micro-TESE), Open Testicular Biopsy using surgical Microscope
| Study group | Role | What they receive |
|---|---|---|
| SIVCA | Experimental | Aspirating testicular tissue using a standard IV cannula with applied negative pressure. Receives: Procedure: Micro-TESE |
| Micro-TESE | Active comparator | Extracting testicular tissue surgically Receives: Device: Standard IV Cannula for aspiration of testicular sperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of Testicular Tissue Retrieval
If more than 0.3 grams of testicular tissue could be adequately collected from the procedure
Measured: Intraoperative
Secondary outcomes (1)
Sperm Retrieval Rate
If Sperm could be found in the collected testicular tissue sample, either aspirated or surgically extracted
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Jan 2019
- Primary completion1 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Obstructive AzoospermiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham ZAAZAA, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247723
- Sponsor's protocol ID
- SIVCA
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected during the trial after deidentification, beginning 9 months and ending 36 months after publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique
- ClinicalTrials.gov ID
- NCT05247723
- Acronym / sponsor ID
- SIVCA
- Conditions
- Non Obstructive Azoospermia
- Keywords
- Non Obstructive Azoospermia, Fine Needle Aspiration, Micro-TESE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SIVCA | Experimental | Procedure: Micro-TESEAspirating testicular tissue using a standard IV cannula with applied negative pressure. |
| Micro-TESE | Active comparator | Device: Standard IV Cannula for aspiration of testicular spermExtracting testicular tissue surgically |
Who may qualify
- Ages
- 22 to 52 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non Obstructive Azoospermia
- Normal Sized testes (Above 12ml in volume)
Key exclusion criteria (2 listed)
- Obstructive Azoospermia
- Small sized testes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard IV Cannula for aspiration of testicular spermAfter 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. | Device | Micro-TESE |
| Micro-TESEConventional Microscopic Testicular Sperm Extraction (Micro-TESE), Open Testicular Biopsy using surgical Microscope | Procedure or surgery | SIVCA |
Primary outcome
Weight of Testicular Tissue Retrieval
Time frame: Intraoperative
If more than 0.3 grams of testicular tissue could be adequately collected from the procedure
1 secondary outcome
Sperm Retrieval Rate
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Yes. All IPD collected during the trial after deidentification, beginning 9 months and ending 36 months after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard IV Cannula for aspiration of testicular sperm and Micro-TESE in people with Non Obstructive Azoospermia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of Testicular Tissue Retrieval (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.