Laser Assisted ICSI; Has it Role Whatsoever?

Study Overview
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Brief Summary
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laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI technique with assisted hatching.This procedure is usually used for MII oocytes possessing oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially because data indicated that in addition to an improved oocyte survival, this new approach increases the hatching rate in vitro. But since it is still debatable that such a small opening might impair the hatching process, so modified zona thinning technique was proposed for more embryo safety.

Detailed Description
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This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively assess whether this approach can be applied routinely to improve ICSI outcome. One arm study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes. The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation rates were assessed in the three groups Cases were randomly selected for embryo transfer from the three groups,Then chemical pregnancy and clinical pregnancy rates were compared between the three groups.

Official Title
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Laser Assisted ICSI; Has it Role Whatsoever? Does it Affect the ICSI Outcome Positively?1

Conditions
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Laser Assistance to Improve ICSI Outcome

Intervention / Treatment
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* Procedure: Laser Assisted ICSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged from 20 years old to 37 years old good res-ponders gives more than 15 oocytes endometrial thickness more than 9 mm Exclusion Criteria: poor res-ponders severe oligoasthinozoospermia of male partners testicular samples Poor quality oocytes

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes. then Cases randomly selected for embryo transfer from each group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Conventional ICSI procedure was done for first portion of sibling oocytes | |
| Experimental: Study group 1<br>Laser assisted drilling ICSI procedure was done for second portion of sibling oocytes | Procedure: Laser Assisted ICSI<br>* using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome<br>|
| Experimental: Study group 2<br>Laser assisted thinning ICSI procedure was done for Third portion of sibling oocytes | Procedure: Laser Assisted ICSI<br>* using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | confirmed by sac observation using ultrasound | three-four weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastulation rate | number of blastocysts that are grown from devided embryos | 5 days later after ICSI procedure | 
| Hatching rate | number of blastocysts that hatch out of zona | 5 days later after ICSI procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser assisted-ICSI, Zona pellucida thinning, ICSI, embryo good quality rate, hatching rate