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Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B (ICSI-CB)

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: NCT03663634
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Banoon IVF Center
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital

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. Cytochalasin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin 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: Cytochalasin B use in ICSI handling medium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 987 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cytochalasin B Supplementation to ICSI Handling Medium
Actual Study Start Date : September 16, 2018
Actual Primary Completion Date : July 20, 2019
Actual Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: Handling Medium Supplemented with Cytochalasin B Other: Cytochalasin B use in ICSI handling medium
A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate

No Intervention: Handling Medium as it is.



Primary Outcome Measures :
  1. oocyte survival rate [ Time Frame: 6 days of culture ]
    number of survived oocyte after intracytoplasmic sperm injection


Secondary Outcome Measures :
  1. fertilization rate [ Time Frame: 6 days of culture ]
    number of fertilized oocytes per metaphase II injected

  2. blastocyst formation rate [ Time Frame: 6 days of culture ]
    number of formed blastocyst per fertilized oocyte

  3. embryo utilization rate [ Time Frame: 6 days of culture ]
    number of embryo transferred added to number of those cryopreserved per fertilized oocyte

  4. clinical pregnancy rate [ Time Frame: three months ]
    number of women with a heartbeat at week 4 or more after embryo transfer

  5. ongoing pregnancy rate [ Time Frame: four months ]
    number of women with continued pregnancy after twelve weeks of gestation



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All ICSI candidates patients

Exclusion Criteria:

  • No exclusion

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): NCT03663634


Locations
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Egypt
IbnSina IVF Center
Sohag, Egypt
Sponsors and Collaborators
Ibn Sina Hospital
Banoon IVF Center
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Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT03663634    
Other Study ID Numbers: IbnSinaIVF-ICSI-CB
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Genital Diseases, Male
Genital Diseases, Female