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Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678597
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital

Study Description
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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,

Condition or disease Intervention/treatment Phase
Infertility Other: Medium Supplemented with Latrunculin B Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Latrunculin B Supplementation to ICSI Handling Medium
Actual Study Start Date : September 25, 2018
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Handling Medium Supplemented with Latrunculin B Other: Medium Supplemented with Latrunculin B
A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate
No Intervention: handling Medium as it is.


Outcome Measures
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Primary Outcome Measures :
  1. oocyte survival rate after ICSI [ Time Frame: 6 days of culture ]

Secondary Outcome Measures :
  1. Fertilisation rate [ Time Frame: 6 days of culture ]
  2. Rates of blastocyst formation and quality [ Time Frame: 6 days of culture ]
    Number of formed and high-quality blastocysts per fertilized oocytes

  3. Clinical pregnancy rate [ Time Frame: three months ]
  4. Implantation rate [ Time Frame: 7 weeks ]
  5. Ongoing pregnancy rate [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All ICSI cycles

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678597


Locations
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Egypt
Banon Assiut
Assiut, Egypt
Qena Fertility Center
Qena, Egypt, 123456
IbnSina IVF Center, IbnSina Hospital
Sohag, Egypt, 12345
Sponsors and Collaborators
Ibn Sina Hospital
More Information
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Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT03678597    
Other Study ID Numbers: IbnSinaIVF-ICSI-LB
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility