Laser Assisted ICSI; Has it Role Whatsoever?

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

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.

Study Overview

• Status: Suspended
• Conditions: Laser Assistance to Improve ICSI Outcome
• Intervention / Treatment: Procedure: Laser Assisted ICSI

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Daqahlia
    • Mansoura, Daqahlia, Egypt, 12111
      • Royal Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 37 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royal Fertility Center, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: ICSI; Laser assisted-ICSI; Zona pellucida thinning; embryo good quality rate; hatching rate
• Other Study ID Numbers: RoyalFertility 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes