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

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).

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Key information

Conditions

Azoospermia Genital Diseases Genital Diseases, Male IVF Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajyal Hospital, IVF Center

Sohag, 82524, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser Assisted Immotile Sperm Selection

Device

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.

Hypo-osmotic Swelling Test

Procedure

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.

Primary outcomes

Clinical pregnancy rate

Time frame: 6- 7 weeks

Presence of a fetal heartbeat at 6-7 weeks of pregnancy.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Dec 19, 2020
Registry last updated: Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed