Laser Assisted ICSI; Has it Role Whatsoever?

Not Applicable

Suspended

• Conditions: Laser Assistance to Improve ICSI Outcome
• Interventions: Procedure: Laser Assisted ICSI

• Registration Number: NCT04455412
• Lead Sponsor: Royal Fertility Center, Egypt

Brief Summary

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

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 Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-06-28
• Study First Posted: 2020-07-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group 2	Laser Assisted ICSI	Laser assisted thinning ICSI procedure was done for Third portion of sibling oocytes
Study group 1	Laser Assisted ICSI	Laser assisted drilling ICSI procedure was done for second portion of sibling oocytes

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	three-four weeks after embryo transfer	confirmed by sac observation using ultrasound

Secondary Outcome Measures

Name	Time	Method
Blastulation rate	5 days later after ICSI procedure	number of blastocysts that are grown from devided embryos
Hatching rate	5 days later after ICSI procedure	number of blastocysts that hatch out of zona

Trial Locations

Locations (1)

Royal Fertility Center; 🇪🇬 Mansoura, Daqahlia, Egypt