- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678571
Oocyte Vitrification Aided With Latrunculin A
July 14, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital
Latrunculin A for Oocyte Vitrification
Using cytoskeleton Stabilizer the Latrunculin A would improve the outcome of oocyte vitrification
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
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
-
Qena, Egypt, 123456
- Qena Fertility Center
-
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:
- indication for oocyte cryopreservation
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 |
---|---|
Experimental: Latrunculin A supplemented vitrification medium
|
Vitrification of human oocyte in medium supplemented with Latrunculin A
|
No Intervention: Vitrification medium with no supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival after thawing
Time Frame: 6 days after thawing
|
6 days after thawing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fertilization rate
Time Frame: 6 days of culture
|
6 days of culture
|
|
Rates of blastocyst formation and quality
Time Frame: 6 days of culture
|
Number of formed blastocyst and high-quality blastocysts per fertilized oocytes
|
6 days of culture
|
embryo utilization rate
Time Frame: 6 days of culture
|
Number of utilized embryos per fertilized oocytes
|
6 days of culture
|
clinical pregnancy rate
Time Frame: three months
|
Number of pregnant women with fetal pulsation per recruited cycles
|
three months
|
ongoing pregnancy rate
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
July 1, 2019
Study Completion (Actual)
July 15, 2019
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 16, 2019
Last Update Submitted That Met QC Criteria
July 14, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IbnSina-Oocyte-LA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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