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Laser Assisted ICSI; Has it Role Whatsoever?

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04455412
Enrollment
120
Registered
2020-07-02
Start date
2020-02-01
Completion date
2024-01-31
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laser Assistance to Improve ICSI Outcome

Keywords

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

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.

Interventions

PROCEDURELaser Assisted ICSI

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

Sponsors

Royal Fertility Center, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 37 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy ratethree-four weeks after embryo transferconfirmed by sac observation using ultrasound

Secondary

MeasureTime frameDescription
Blastulation rate5 days later after ICSI procedurenumber of blastocysts that are grown from devided embryos
Hatching rate5 days later after ICSI procedurenumber of blastocysts that hatch out of zona

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026