Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease Intervention/treatment Phase
Infertility Other: Laser-assisted ICSI Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 966 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laser-assisted ICSI Effect on Degeneration Rate After ICSI
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 5, 2019

Arm Intervention/treatment
Experimental: Laser-assisted ICSI Other: Laser-assisted ICSI
Laser opening of the zona pellucida.

No Intervention: conventional ICSI



Primary Outcome Measures :
  1. oocyte survival after injection [ Time Frame: 6 days of culture ]

Secondary Outcome Measures :
  1. blastocyst formation rate [ Time Frame: 6 days of culture ]
  2. embryo utilization rate [ Time Frame: 6 days of culture ]
  3. clinical pregnancy rate [ Time Frame: four weeks after embryo transfer ]
  4. ongoing pregnancy rate [ Time Frame: Twelve weeks of gestation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all ICSI cycles

Exclusion Criteria:

  • no exclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665103


Locations
Layout table for location information
Egypt
IbnSina IVF Center
Sohag, Egypt
Sponsors and Collaborators
Ibn Sina Hospital

Layout table for additonal information
Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT03665103     History of Changes
Other Study ID Numbers: Laser-ICSI
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female