The Acceptance, Safety, and Efficacy of MadaJet Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia

NCT03181243 | Completed

• 1 other identifier: NCKH/CGRH_03_2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (9)

• Pressure (fear) of the patients

  1 year

• Discomfort of the patients

  1 year

• Incidence of treatment (Bleeding)

  1 year

• Incidence of treatment (Swelling)

  1 year

• Incidence of treatment (Hematoma)

  1 year

Study Arms (2)

MadaJet

EXPERIMENTAL

Jet injector (Madajet medical Urology) preloaded as manufacturer's instruction

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%

Procedure: Needle injection

Interventions

Madajet PROCEDURE

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.

Also known as: Needle-free jet anaesthetic technique

MadaJet

Needle injection PROCEDURE

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.

Also known as: Local aesthesia by needle injection

Needle injection

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vietnam National University: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, 84, Vietnam

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Needles

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Khoa D Le, Dr

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 8, 2017
• Study Start: July 15, 2017
• Primary Completion: December 25, 2017
• Study Completion: December 25, 2017
• Last Updated: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)