Back to resultsTruth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage
Primary Purpose
Blastocyst Disintegration
Status
Terminated
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser assisted collapse
Sponsored by
About this trial
This is an interventional basic science trial for Blastocyst Disintegration focused on measuring blastocyst, Vitrification, artificial collapse, survival rate
Eligibility Criteria
Inclusion Criteria:
- Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4
Exclusion Criteria:
- bad quality blastocysts expansion rate less than 3
Sites / Locations
- Hawaa Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group (artificially laser-collapsed blastocysts)
& control group (blastocysts were vitrified, no laser collapse
Arm Description
laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification
blastocyst were vitrified without laser assisted collapse
Outcomes
Primary Outcome Measures
survival rate
survival rate will be assessed immediately after thawing and compared between both groups.
survival rate
survival rate will be assessed at 140 minutes after thawing and compared between both groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT04124809
First Posted
October 8, 2019
Last Updated
September 18, 2022
Sponsor
Benha University
Collaborators
Hawaa Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT04124809
Brief Title
Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage
Official Title
Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
no fund for recruitment
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Hawaa Fertility Center
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
: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.
Detailed Description
One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) & control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately & at 140 min after thawing and compared between two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blastocyst Disintegration
Keywords
blastocyst, Vitrification, artificial collapse, survival rate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) & control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately & at 140 min after thawing and compared between two groups.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
only the investigator knew the procedure provided for each case
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group (artificially laser-collapsed blastocysts)
Arm Type
Experimental
Arm Description
laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification
Arm Title
& control group (blastocysts were vitrified, no laser collapse
Arm Type
No Intervention
Arm Description
blastocyst were vitrified without laser assisted collapse
Intervention Type
Device
Intervention Name(s)
laser assisted collapse
Intervention Description
Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts
Primary Outcome Measure Information:
Title
survival rate
Description
survival rate will be assessed immediately after thawing and compared between both groups.
Time Frame
immediately after thawing
Title
survival rate
Description
survival rate will be assessed at 140 minutes after thawing and compared between both groups.
Time Frame
140 min after thawing
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
blastocysts of infertile couples
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4
Exclusion Criteria:
bad quality blastocysts expansion rate less than 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sahar A Eissa, Ph. D
Organizational Affiliation
HFC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawaa Fertility Center
City
Banhā
State/Province
Qalyubiya
ZIP/Postal Code
13512
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the main individual characters of the blastocysts and he data after warming
IPD Sharing Time Frame
After publication of the study , for 6 months
IPD Sharing Access Criteria
saharafify @yahoo.com
Learn more about this trial
Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage
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