The Acceptance, Safety, and Efficacy of MadaJet Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male; Azoospermia
Study type: Interventional

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.
    

Intervention name(s): Madajet; Needle injection
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Needle-free jet anaesthetic technique; Local aesthesia by needle injection
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment