Laser Assisted ICSI; Has it Role Whatsoever?

Royal Fertility Center, Egypt

Status: Suspended

Conditions: Laser Assistance to Improve ICSI Outcome

Treatments: Procedure: Laser Assisted ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT04455412

RoyalFertility 001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

control group

No Intervention group

Description:

Conventional ICSI procedure was done for first portion of sibling oocytes

Study group 1

Experimental group

Description:

Laser assisted drilling ICSI procedure was done for second portion of sibling oocytes

Treatment:

Procedure: Laser Assisted ICSI

Study group 2

Experimental group

Description:

Laser assisted thinning ICSI procedure was done for Third portion of sibling oocytes

Treatment:

Procedure: Laser Assisted ICSI