Male InfertilityNCT03181243
The Acceptance, Safety, and Efficacy of MadaJet Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
A study testing Madajet and Needle injection in people with Male Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial summary
To compare the acceptance, safety, and efficacy of needle-free jet anaesthetic technique (MadaJet) versus needle injection for sperm retrieval in patients with azoospermia. Read more about this study
- Who is it for?
- Ages 20 to 100 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Madajet and Needle injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jul 2017to 25 Dec 2017
- 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 20 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (including obstructive azoospermia and non-obstructive azoospermia) in need of sperm retrieval (PESA, TESE) for ICSI.
Who cannot join
- Have not finished the process of sperm retrieval techniques.
- Malformation of genital organs (e.g. spermatic cord, testicle)
- Anxious, alcoholic patients.
- Patients giving a history of personality disorders.
- Patients who abuse drugs.
- Disagree to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acceptance, Safety, and Efficacy of Needle-free Jet Anaesthetic Technique (MadaJet) Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
To compare the acceptance, safety, and efficacy of needle-free jet anaesthetic technique (MadaJet) versus needle injection for sperm retrieval in patients with azoospermia.
Read the detailed description
Azoospermia is found in 1-3% of general population and 10-15% of men presenting with infertility. In this scenario, there are no spermatozoa in the patient's semen after centrifugation, and pregnancy may be achieved through IVF/ Intracytoplasmic sperm injection (ICSI) combined with sperm retrieval techniques (e.g. PESA, testicular sperm extraction - TESE, TESA). These techniques are commonly conducted under local anesthesia, which a 10-15 mL solution of 2% lidocaine hydrochloride injected around the spermatic cord near the external inguinal ring. However, needle fear is prevalent in both children (~33-63%) and adults (~14-38%) and can contribute to negative experiences with needle procedures and health care for patients, caregivers, and health professionals. In clinical practice, patients often concern about the pain, trauma and possible complication (i.e. wheal, hematoma, infection) of needle injection of local anaesthesia into and through the scrotal wall when performing sperm retrieval. It not only interferes with clinicians' abilities to carry out procedures (e.g. due to flailing and attempts to escape), but also undermines the efficacy of pain interventions at the time of the needle. Therefore, receiving local anaesthesia without a needle is easily well accepted by the patients with azoospermia.
The needleless jet injector (MadaJet Medical Injector) has been widely used in the fields of dermatology, cosmetic and plastic surgery, gynecology, dentistry, and podiatry as well as for immunization. It was also employed for no-scalpel vasectomy in Urology/Andrology. The first studies using needleless jet injector for spermatic cord block was reported by Wilson in 2001 and Weiss in 2005. The next studies showed that MadaJet has better outcomes (e.g. cost, pain scores, onset time) than traditional needle anaesthesia (16-18). Unlike a conventional spermatic cord block with needle injection, there is no wheal on the patients' skin and local edema after administering injection. A mist of solution with a high-pressure injector will be rapidly delivered and absorbed through the skin to the tissue beneath around the cord with much less trauma. As a consequence, it is less painful than the needle injection.
For those reasons, a needle-free jet anaesthetic technique for sperm retrieval will be described for local anaesthesia, which may minimize the fear of the needle. The acceptance, safety, and efficacy of this technique will also be compared with needle injection for sperm retrieval in azoospermia patients.
- Conditions
- Male Infertility
- Being tested
- Madajet, Needle injection
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MadajetProcedure or surgery
Also called Needle-free jet anaesthetic technique
The spermatic cord is firmly trapped between the middle finger, index finger and thumb of the left hand. The injector's sheath is placed over the spermatic cord with gentle pressure adjacent to the external inguinal ring. Depending upon the thickness of spermatic cord, three or four injections are consecutively administered around it, beginning from proximal to distal points.
Needle injectionProcedure or surgery
Also called Local aesthesia by needle injection
The pubic tubercle is palpated on the side that is going to be blocked. The spermatic cord is then immobilised with the non-dominant hand between the thumb and index finger. Right after needle puncture with attached syringe and local anaesthetic solution is conducted at a point that is 1 cm inferior to and 1 cm medial to the pubic tubercle, pass the needle directly downward in a vertical fashion, which leads it into the spermatic cord. After a check-up (negative aspiration) for bleeding, approximately 3 mL of solution (Lidocaine 2%) is injected into the cord.
| Study group | Role | What they receive |
|---|---|---|
| MadaJet | Experimental | Jet injector (Madajet medical Urology) preloaded as manufacturer's instruction Receives: Procedure: Madajet |
| Needle injection | Experimental | 01 sterile 10-mL syringe with small gauge needle (25 ga), solution for sterile preparation, 10 - 15 mL Lidocaine 2% Receives: Procedure: Needle injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Right after completing the injection, information about the pain before, during and after the sperm retrieval technique will be immediately documented by the visual analog scale (VAS) questionnaire on 10 cm lines (0 represents no pain, whereas 10 marks the highest score).
Measured: 1 year
Secondary outcomes (9)
Pressure (fear) of the patients
Right after completing the injection, information about the pain before, during and after the sperm retrieval technique will be immediately documented by the visual analog scale (VAS) questionnaire on 10 cm lines (0 represents no pain, whereas 10 marks the highest score).
Measured: 1 year
Discomfort of the patients
Right after completing the injection, information about the pain before, during and after the sperm retrieval technique will be immediately documented by the visual analog scale (VAS) questionnaire on 10 cm lines (0 represents no pain, whereas 10 marks the highest score).
Measured: 1 year
Incidence of treatment (Bleeding)
Bleeding will be recorded peri- and post- operative anesthesia.
Measured: 1 year
Incidence of treatment (Swelling)
Swelling will be recorded peri- and post- operative anesthesia.
Measured: 1 year
Incidence of treatment (Hematoma)
Hematoma will be recorded peri- and post- operative anesthesia.
Measured: 1 year
Onset of action of Madajet
By using the stopwatch, the onset of action of anesthesia will be recorded. Every five seconds, the pain reaction which shows the onset is determined on the scrotum by using tissue forceps.
Measured: 1 year
Duration of action of Madajet
By using the stopwatch, the duration of action of anesthesia will be recorded. The patients are observed in the operation room until all the symptoms of anesthesia wore off. The total duration of anesthesia is measured from the time of onset until the patient reports normal reaction in the scrotum.
Measured: 1 year
Onset of action of Needle injection
By using the stopwatch, the onset of action of anesthesia will be recorded. Every thirty seconds, the pain reaction which shows the onset is determined on the scrotum by using tissue forceps.
Measured: 1 year
Duration of action of Needle injection
By using the stopwatch, the duration of action of anesthesia will be recorded. The patients are observed in the operation room until all the symptoms of anesthesia wore off. The total duration of anesthesia is measured from the time of onset until the patient reports normal reaction in the scrotum.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start15 Jul 2017
- Primary completion25 Dec 2017
- Study completion25 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- 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
- Because the length of sperm retrieval procedure is significantly different between groups, we use matched pairs based on the length of procedure as the matching variable for the primary outcome (pain relief) by specify two in one block. We create a block 2 to assign sample numbers equally to each group (MadaJet or needle injection) and assign equitably the block to each procedure (TESE or PESA). Therefore, patients will be randomized, using a computer-generated randomization list in a 1:1 ratio and block 2, to either the MadaJet group or to needle injection group after the assessment of eligibility and signing informed consents. Allocation of patients will be done by a third-party via telephone according to the specified list. The patients don't know which anaesthesia technique will be performed.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Khoa D Le, Dr, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181243
- Sponsor's protocol ID
- NCKH/CGRH_03_2017
- Status last verified
- Dec 2017
- First submitted
- 2 Jun 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptance, Safety, and Efficacy of Needle-free Jet Anaesthetic Technique (MadaJet) Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
- ClinicalTrials.gov ID
- NCT03181243
- Acronym / sponsor ID
- NCKH/CGRH_03_2017
- Conditions
- Male Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 8 Jun 2017 (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.
To compare the acceptance, safety, and efficacy of needle-free jet anaesthetic technique (MadaJet) versus needle injection for sperm retrieval in patients with azoospermia.
Detailed description
Azoospermia is found in 1-3% of general population and 10-15% of men presenting with infertility. In this scenario, there are no spermatozoa in the patient's semen after centrifugation, and pregnancy may be achieved through IVF/ Intracytoplasmic sperm injection (ICSI) combined with sperm retrieval techniques (e.g. PESA, testicular sperm extraction - TESE, TESA). These techniques are commonly conducted under local anesthesia, which a 10-15 mL solution of 2% lidocaine hydrochloride injected around the spermatic cord near the external inguinal ring. However, needle fear is prevalent in both children (~33-63%) and adults (~14-38%) and can contribute to negative experiences with needle procedures and health care for patients, caregivers, and health professionals. In clinical practice, patients often concern about the pain, trauma and possible complication (i.e. wheal, hematoma, infection) of needle injection of local anaesthesia into and through the scrotal wall when performing sperm retrieval. It not only interferes with clinicians' abilities to carry out procedures (e.g. due to flailing and attempts to escape), but also undermines the efficacy of pain interventions at the time of the needle. Therefore, receiving local anaesthesia without a needle is easily well accepted by the patients with azoospermia.
The needleless jet injector (MadaJet Medical Injector) has been widely used in the fields of dermatology, cosmetic and plastic surgery, gynecology, dentistry, and podiatry as well as for immunization. It was also employed for no-scalpel vasectomy in Urology/Andrology. The first studies using needleless jet injector for spermatic cord block was reported by Wilson in 2001 and Weiss in 2005. The next studies showed that MadaJet has better outcomes (e.g. cost, pain scores, onset time) than traditional needle anaesthesia (16-18). Unlike a conventional spermatic cord block with needle injection, there is no wheal on the patients' skin and local edema after administering injection. A mist of solution with a high-pressure injector will be rapidly delivered and absorbed through the skin to the tissue beneath around the cord with much less trauma. As a consequence, it is less painful than the needle injection.
For those reasons, a needle-free jet anaesthetic technique for sperm retrieval will be described for local anaesthesia, which may minimize the fear of the needle. The acceptance, safety, and efficacy of this technique will also be compared with needle injection for sperm retrieval in azoospermia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Because the length of sperm retrieval procedure is significantly different between groups, we use matched pairs based on the length of procedure as the matching variable for the primary outcome (pain relief) by specify two in one block. We create a block 2 to assign sample numbers equally to each group (MadaJet or needle injection) and assign equitably the block to each procedure (TESE or PESA). Therefore, patients will be randomized, using a computer-generated randomization list in a 1:1 ratio and block 2, to either the MadaJet group or to needle injection group after the assessment of eligibility and signing informed consents. Allocation of patients will be done by a third-party via telephone according to the specified list. The patients don't know which anaesthesia technique will be performed.
| Arm | Type | Receives |
|---|---|---|
| MadaJet | Experimental | Procedure: MadajetJet injector (Madajet medical Urology) preloaded as manufacturer's instruction |
| Needle injection | Experimental | Procedure: Needle injection01 sterile 10-mL syringe with small gauge needle (25 ga), solution for sterile preparation, 10 - 15 mL Lidocaine 2% |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (including obstructive azoospermia and non-obstructive azoospermia) in need of sperm retrieval (PESA, TESE) for ICSI.
Key exclusion criteria (6 listed)
- Have not finished the process of sperm retrieval techniques.
- Malformation of genital organs (e.g. spermatic cord, testicle)
- Anxious, alcoholic patients.
- Patients giving a history of personality disorders.
- Patients who abuse drugs.
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 |
|---|---|---|
| MadajetAlso: Needle-free jet anaesthetic techniqueThe spermatic cord is firmly trapped between the middle finger, index finger and thumb of the left hand. The injector's sheath is placed over the spermatic cord with gentle pressure adjacent to the external inguinal ring. Depending upon the thickness of spermatic cord, three or four injections are consecutively administered around it, beginning from proximal to distal points. | Procedure or surgery | MadaJet |
| Needle injectionAlso: Local aesthesia by needle injectionThe pubic tubercle is palpated on the side that is going to be blocked. The spermatic cord is then immobilised with the non-dominant hand between the thumb and index finger. Right after needle puncture with attached syringe and local anaesthetic solution is conducted at a point that is 1 cm inferior to and 1 cm medial to the pubic tubercle, pass the needle directly downward in a vertical fashion, which leads it into the spermatic cord. After a check-up (negative aspiration) for bleeding, approximately 3 mL of solution (Lidocaine 2%) is injected into the cord. | Procedure or surgery | Needle injection |
Primary outcome
Pain score
Time frame: 1 year
Right after completing the injection, information about the pain before, during and after the sperm retrieval technique will be immediately documented by the visual analog scale (VAS) questionnaire on 10 cm lines (0 represents no pain, whereas 10 marks the highest score).
9 secondary outcomes
Pressure (fear) of the patients
Time frame: 1 year
Discomfort of the patients
Time frame: 1 year
Incidence of treatment (Bleeding)
Time frame: 1 year
Incidence of treatment (Swelling)
Time frame: 1 year
Incidence of treatment (Hematoma)
Time frame: 1 year
Onset of action of Madajet
Time frame: 1 year
Duration of action of Madajet
Time frame: 1 year
Onset of action of Needle injection
Time frame: 1 year
Duration of action of Needle injection
Time frame: 1 year
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 2 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Khoa D Le, Dr principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Madajet and Needle injection in people with Male Infertility, run by Vietnam National University at 1 site in Vietnam.
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 1 inclusion and 6 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 2 Jan 2018. 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 Vietnam. 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?
Pain score (time frame: 1 year). 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 2 Jan 2018.