An interventional study of Laser Assisted Immotile Sperm Selection and Hypo-osmotic Swelling Test in Azoospermia and IVF, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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).
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's enrollment of 168 is above the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).
Device: Laser Assisted Immotile Sperm Selection
Viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
Procedure: Hypo-osmotic Swelling Test
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.
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.
Clinical pregnancy rate
Presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Time frame: 6- 7 weeks
Plan to share: Yes — Share IPD upon justified request to study director
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data shall become permanently available for share in Q3 2022.
Access criteria: Justified request to study director
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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