Laser Assisted ICSI; Has it Role Whatsoever? | NCT04455412

Studies
Laser Assisted ICSI; Has it Role Whatsoever?

NCT04455412

Sponsor

Royal Fertility Center, Egypt

Status

Suspended

Last Update Posted

Sep 21, 2022Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Laser Assistance to Improve ICSI Outcome

Interventions

Laser Assisted ICSI

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment is stopped waiting for funds

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Jan 2024Estimated

First Submitted Date

Jun 28, 2020

First Submission Date that Met QC Criteria

Jun 28, 2020

First Posted Date

Jul 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2022

Last Update Posted Date

Sep 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	confirmed by sac observation using ultrasound	three-four weeks after embryo transfer

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Fertility Center		Al Mansurah	Dakahlia Governorate	12111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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