Laser Assisted ICSI; Has it Role Whatsoever?

NCT ID: NCT04455412

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Laser Assistance to Improve ICSI Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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control group

Conventional ICSI procedure was done for first portion of sibling oocytes

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group 1

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

Group Type EXPERIMENTAL

Laser Assisted ICSI

Intervention Type PROCEDURE

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

Study group 2

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

Group Type EXPERIMENTAL

Laser Assisted ICSI

Intervention Type PROCEDURE

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

Interventions

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Laser Assisted ICSI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Fertility Center, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Fertility Center

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RoyalFertility 001

Identifier Type: -

Identifier Source: org_study_id

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