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

Study Overview
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Brief Summary
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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).

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

Conditions
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Azoospermia, IVF

Intervention / Treatment
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* Device: Laser Assisted Immotile Sperm Selection
* Procedure: Hypo-osmotic Swelling Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: (LAISS) group: viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). (HOST) group: viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LAISS group<br>Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). | Device: Laser Assisted Immotile Sperm Selection<br>* 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.<br>|
| Active Comparator: HOST group<br>Viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group). | Procedure: Hypo-osmotic Swelling Test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Presence of a fetal heartbeat at 6-7 weeks of pregnancy. | 6- 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Assisted Immotile Sperm Selection, Hypo-osmotic swelling test, ICSI, Testicular sperm