Back to resultsSupplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Medium Supplemented with Latrunculin B
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- All ICSI cycles
Exclusion Criteria:
-
Sites / Locations
- Banon Assiut
- Qena Fertility Center
- IbnSina IVF Center, IbnSina Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Handling Medium Supplemented with Latrunculin B
handling Medium as it is.
Arm Description
Outcomes
Primary Outcome Measures
oocyte survival rate after ICSI
Secondary Outcome Measures
Fertilisation rate
Rates of blastocyst formation and quality
Number of formed and high-quality blastocysts per fertilized oocytes
Clinical pregnancy rate
Implantation rate
Ongoing pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03678597
Brief Title
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
Official Title
Latrunculin B Supplementation to ICSI Handling Medium
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
March 25, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Latrunculin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,
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
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Handling Medium Supplemented with Latrunculin B
Arm Type
Experimental
Arm Title
handling Medium as it is.
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Medium Supplemented with Latrunculin B
Intervention Description
A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate
Primary Outcome Measure Information:
Title
oocyte survival rate after ICSI
Time Frame
6 days of culture
Secondary Outcome Measure Information:
Title
Fertilisation rate
Time Frame
6 days of culture
Title
Rates of blastocyst formation and quality
Description
Number of formed and high-quality blastocysts per fertilized oocytes
Time Frame
6 days of culture
Title
Clinical pregnancy rate
Time Frame
three months
Title
Implantation rate
Time Frame
7 weeks
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:
All ICSI cycles
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, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt
12. IPD Sharing Statement
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Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
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