Clinical trial NCT03181243: The Acceptance, Safety, and Efficacy of MadaJet Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
Official title: The Acceptance, Safety, and Efficacy of Needle-free Jet Anaesthetic Technique (MadaJet) Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Lead sponsor: Vietnam National University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients (including obstructive azoospermia and non-obstructive azoospermia) in need of sperm retrieval (PESA, TESE) for ICSI.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain score
timeFrame: 1 year
Secondary outcomes:
measure: Pressure (fear) of the patients
timeFrame: 1 year
measure: Discomfort of the patients
timeFrame: 1 year
measure: Incidence of treatment (Bleeding)
timeFrame: 1 year
measure: Incidence of treatment (Swelling)
timeFrame: 1 year
measure: Incidence of treatment (Hematoma)
timeFrame: 1 year
measure: Onset of action of Madajet
timeFrame: 1 year
measure: Duration of action of Madajet
timeFrame: 1 year
measure: Onset of action of Needle injection
timeFrame: 1 year
measure: Duration of action of Needle injection
timeFrame: 1 year
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: Mỹ Đức Hospital
name: Khoa D Le, Dr
role: PRINCIPAL_INVESTIGATOR
References: