Back to resultsHandling Medium for ICSI With Ionomycin and Latrunculin A
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- indication for ICSI
Exclusion Criteria:
-
Sites / Locations
- Banon Assiut
- Qena Fertility Center
- IbnSina IVF Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ICSI medium supplemented with Ionomycin and Latrunculin A
ICSI medium as it is
Arm Description
Outcomes
Primary Outcome Measures
Fertilization rate
Secondary Outcome Measures
Rates of Blastocyst formation and quality
Number of formed blastocysts and blastocysts with good-quality per fertilized oocytes
embryo utilization rate
clinical pregnancy rate
ongoing pregnancy rate
Full Information
NCT ID
NCT03678610
First Posted
September 17, 2018
Last Updated
May 5, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Qena Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT03678610
Brief Title
Handling Medium for ICSI With Ionomycin and Latrunculin A
Official Title
Latrunculin A and Ionomycin as a Handling Medium for ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Qena 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
Using Latrunculin A and Ionomycin would improve the outcome of ICSI if the handling medium during the ICSI procedure has them.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICSI medium supplemented with Ionomycin and Latrunculin A
Arm Type
Experimental
Arm Title
ICSI medium as it is
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A
Intervention Description
Ionomycin and Latrunculin A would activate oocyte during ICSI along with cytoskeleton stabilization for a favourable outcomes
Primary Outcome Measure Information:
Title
Fertilization rate
Time Frame
6 days of culture
Secondary Outcome Measure Information:
Title
Rates of Blastocyst formation and quality
Description
Number of formed blastocysts and blastocysts with good-quality per fertilized oocytes
Time Frame
6 days of culture
Title
embryo utilization rate
Time Frame
6 days of culture
Title
clinical pregnancy rate
Time Frame
three months
Title
ongoing pregnancy rate
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indication for ICSI
Exclusion Criteria:
-
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Handling Medium for ICSI With Ionomycin and Latrunculin A
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