Laser Assisted ICSI; Has it Role Whatsoever?

Laser Assistance to Improve ICSI Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04455412
• Other study ID #: RoyalFertility 001
• Status: Suspended
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 2024

Study information

• Verified date: September 2022
• Source: Royal Fertility Center, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Laser Assistance to Improve ICSI Outcome

Intervention

Procedure:
• Laser Assisted ICSI
using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome

Locations

Country	Name	City	State
Egypt	Royal Fertility Center	Mansoura	Daqahlia

Sponsors (1)

Lead Sponsor	Collaborator
Royal Fertility Center, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	confirmed by sac observation using ultrasound	three-four weeks after embryo transfer
Secondary	Blastulation rate	number of blastocysts that are grown from devided embryos	5 days later after ICSI procedure
Secondary	Hatching rate	number of blastocysts that hatch out of zona	5 days later after ICSI procedure