Laser Assisted ICSI; Has it Role Whatsoever?

NCT04455412 | Suspended DMC

• 1 other identifier: RoyalFertility 001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Laser Assistance to Improve ICSI Outcome

Keywords

Laser assisted-ICSI; Zona pellucida thinning; ICSI; embryo good quality rate; hatching rate

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  confirmed by sac observation using ultrasound

  three-four weeks after embryo transfer

Secondary Outcomes (2)

• Blastulation rate

  5 days later after ICSI procedure

• Hatching rate

  5 days later after ICSI procedure

Study Arms (3)

control group

NO INTERVENTION

Conventional ICSI procedure was done for first portion of sibling oocytes

Study group 1

EXPERIMENTAL

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

Procedure: Laser Assisted ICSI

Study group 2

EXPERIMENTAL

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

Procedure: Laser Assisted ICSI

Interventions

Laser Assisted ICSI PROCEDURE

using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome

Study group 1; Study group 2

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 20 years old to 37 years old
• good res-ponders
• gives more than 15 oocytes
• endometrial thickness more than 9 mm

You may not qualify if:

• poor res-ponders
• severe oligoasthinozoospermia of male partners
• testicular samples
• Poor quality oocytes

Sponsors & Collaborators

• Royal Fertility Center, Egypt: lead

Study Sites (1)

Royal Fertility Center

Al Mansurah, Dakahlia Governorate, 12111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 2, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)