Laser-assisted ICSI Versus Conventional ICSI | NCT03665103

Studies
Laser-assisted ICSI Versus Conventional ICSI

NCT03665103

Sponsor

Ibn Sina Hospital

Status

Completed

Last Update Posted

Aug 7, 2019Actual

Enrollment

966Actual

Phase

Not Applicable

Conditions

Infertility

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 5, 2019Actual

First Submitted Date

Sep 6, 2018

First Submission Date that Met QC Criteria

Sep 7, 2018

First Posted Date

Sep 11, 2018Actual

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

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Degeneration rate after ICSI is expectable but decreasing it is a goal. Laser-assisted ICSI can serve to decrease this degeneration rate.

Detailed Description

Not provided

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

966Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser-assisted ICSI	Experimental		Other: Laser-assisted ICSI
conventional ICSI	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser-assisted ICSI	Other	Laser opening of the zona pellucida.	Laser-assisted ICSI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oocyte survival after injection		6 days of culture

Secondary Outcomes

Measure	Description	Time Frame
blastocyst formation rate		6 days of culture
embryo utilization rate		6 days of culture
clinical pregnancy rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all ICSI cycles

Exclusion Criteria:

no exclusion

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32995832	Derived	Fawzy M, Emad M, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Elsuity MA, Rashed H, Sabry M. A randomized controlled trial of laser-assisted ICSI. Hum Reprod. 2020 Dec 1;35(12):2692-2700. doi: 10.1093/humrep/deaa160.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases