- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677492
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
May 5, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital
Cytochalasin D Supplementation to ICSI Handling Medium
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 D serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported.
Using Cytochalasin D during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Banon Assiut
-
Sohag, Egypt, 12345
- IbnSina IVF Center, IbnSina Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ICSI indicated participants
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Handling Medium as it is.
|
|
Experimental: Handling Medium Supplemented with Cytochalasin D
|
A medium with in-house supplementation of Cytochalasin D to decrease oocyte degeneration after ICSI and improve the survival rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oocyte survival rate
Time Frame: 6 days of culture
|
6 days of culture
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fertilization rate
Time Frame: 6 days of culture
|
6 days of culture
|
Blastocyst formation rate
Time Frame: 6 days of culture
|
6 days of culture
|
Clinical pregnancy rate
Time Frame: three months
|
three months
|
Implantation rate
Time Frame: 7 weeks
|
7 weeks
|
Ongoing pregnancy rate
Time Frame: 12 weeks
|
12 weeks
|
Embryo utilization rate
Time Frame: 6 days of culture
|
6 days of culture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2018
Primary Completion (Actual)
April 25, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 17, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Actual)
May 7, 2019
Last Update Submitted That Met QC Criteria
May 5, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IbnSinaIVF-ICSI-CD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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