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Laser-assisted ICSI Versus Conventional ICSI

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser-assisted ICSI
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all ICSI cycles

Exclusion Criteria:

  • no exclusion

Sites / Locations

  • IbnSina IVF Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser-assisted ICSI

conventional ICSI

Arm Description

Outcomes

Primary Outcome Measures

oocyte survival after injection

Secondary Outcome Measures

blastocyst formation rate
embryo utilization rate
clinical pregnancy rate
ongoing pregnancy rate

Full Information

First Posted
September 6, 2018
Last Updated
August 5, 2019
Sponsor
Ibn Sina Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03665103
Brief Title
Laser-assisted ICSI Versus Conventional ICSI
Official Title
Laser-assisted ICSI Effect on Degeneration Rate After ICSI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
966 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser-assisted ICSI
Arm Type
Experimental
Arm Title
conventional ICSI
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Laser-assisted ICSI
Intervention Description
Laser opening of the zona pellucida.
Primary Outcome Measure Information:
Title
oocyte survival after injection
Time Frame
6 days of culture
Secondary Outcome Measure Information:
Title
blastocyst formation rate
Time Frame
6 days of culture
Title
embryo utilization rate
Time Frame
6 days of culture
Title
clinical pregnancy rate
Time Frame
four weeks after embryo transfer
Title
ongoing pregnancy rate
Time Frame
Twelve weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all ICSI cycles Exclusion Criteria: no exclusion
Facility Information:
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32995832
Citation
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.
Results Reference
derived

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Laser-assisted ICSI Versus Conventional ICSI

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