- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125017
Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization
October 6, 2023 updated by: Mahmoud Alalfy, Aljazeera Hospital
Comparative Study Between Two Techniques for Artificial Shrinkage of Blastocysts Prior to Vitrification: LASER Pulse Versus Micro-needle Technique in Increasing Chemical, Clinical Pregnancy and Live Birth Rates After ICSI
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing Unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -Also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method
Study Type
Interventional
Enrollment (Actual)
409
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
-
-
-
Giza, Egypt
- Adam
-
-
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
20 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- women with infertility from 20 to 44 years
Exclusion Criteria:
- women with age more than 44 or less than 20
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: effect of using LASER pulse
effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability
|
Using laser pulse before ICSI
Using micro needle technique before ICSI
|
Other: Micro-needle Technique
effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability
|
Using laser pulse before ICSI
Using micro needle technique before ICSI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of women who will have positive pregnancy test
Time Frame: 2 months
|
The number of women who will come pregnant after each technique
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: manal kamel, Adam hospital
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)
January 1, 2019
Primary Completion (Actual)
January 4, 2020
Study Completion (Actual)
February 5, 2020
Study Registration Dates
First Submitted
October 10, 2019
First Submitted That Met QC Criteria
October 10, 2019
First Posted (Actual)
October 14, 2019
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- blastocyst preparation
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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