Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men

IVF Clinical Trial

Official title:

Outcome of ICSI Using Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675164
• Other study ID #: LAISS
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the outcome of ICSI after using LAISS for selection of viable immotile testicular sperm in azoospermic infertile men. Patients will be randomly assigned to 2 groups. In (LAISS) group, viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). In (HOST) group, viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Eligible couples are those undergoing ICSI due to azoospermia with testicular biopsy positive for sperm (either fresh or cryopreserved) following testicular sperm extraction (TESE) or aspiration (TESA).

Exclusion Criteria:

• Cases with female factor infertility or woman age above 35 years will be excluded.

Related Conditions & MeSH terms

• Azoospermia
• IVF

Intervention

Device:
• Laser Assisted Immotile Sperm Selection
LAISS will be performed using diode laser system at the lowest working power with a single laser shot at the lower one third of the sperm tail. If sperm tail curling occurred, the sperm is then viable and will be utilized for ICSI after immobilization in PVP.

Procedure:
• Hypo-osmotic Swelling Test
HOST will be performed by transferring immotile sperms from incubation droplet into HOST droplet, with any sperm showing tail swelling will be identified as viable and will be utilized for ICSI after immediate transfer and immobilization.

Locations

Country	Name	City	State
Egypt	Ajyal Hospital, IVF Center	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Presence of a fetal heartbeat at 6-7 weeks of pregnancy.	6- 7 weeks