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Laser-assisted ICSI Versus Conventional ICSI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03665103
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE September 17, 2018
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
oocyte survival after injection [ Time Frame: 6 days of culture ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • blastocyst formation rate [ Time Frame: 6 days of culture ]
  • embryo utilization rate [ Time Frame: 6 days of culture ]
  • clinical pregnancy rate [ Time Frame: four weeks after embryo transfer ]
  • ongoing pregnancy rate [ Time Frame: Twelve weeks of gestation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser-assisted ICSI Versus Conventional ICSI
Official Title  ICMJE Laser-assisted ICSI Effect on Degeneration Rate After ICSI
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Infertility
Intervention  ICMJE Other: Laser-assisted ICSI
Laser opening of the zona pellucida.
Study Arms  ICMJE
  • Experimental: Laser-assisted ICSI
    Intervention: Other: Laser-assisted ICSI
  • No Intervention: conventional ICSI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)
966
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
300
Actual Study Completion Date  ICMJE August 5, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all ICSI cycles

Exclusion Criteria:

  • no exclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665103
Other Study ID Numbers  ICMJE Laser-ICSI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muhammad Fawzy, Ibn Sina Hospital
Study Sponsor  ICMJE Ibn Sina Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ibn Sina Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP