- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665103
Laser-assisted ICSI Versus Conventional ICSI
August 5, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital
Laser-assisted ICSI Effect on Degeneration Rate After ICSI
Degeneration rate after ICSI is expectable but decreasing it is a goal.
Laser-assisted ICSI can serve to decrease this degeneration rate.
Study Overview
Study Type
Interventional
Enrollment (Actual)
966
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt
- IbnSina IVF Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- all ICSI cycles
Exclusion Criteria:
- no exclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laser-assisted ICSI
|
Laser opening of the zona pellucida.
|
No Intervention: conventional ICSI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oocyte survival after injection
Time Frame: 6 days of culture
|
6 days of culture
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical pregnancy rate
Time Frame: four weeks after embryo transfer
|
four weeks after embryo transfer
|
blastocyst formation rate
Time Frame: 6 days of culture
|
6 days of culture
|
embryo utilization rate
Time Frame: 6 days of culture
|
6 days of culture
|
ongoing pregnancy rate
Time Frame: Twelve weeks of gestation
|
Twelve weeks of gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 5, 2019
Study Registration Dates
First Submitted
September 6, 2018
First Submitted That Met QC Criteria
September 7, 2018
First Posted (Actual)
September 11, 2018
Study Record Updates
Last Update Posted (Actual)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 5, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laser-ICSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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