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Oocyte Vitrification Aided With Cytochalasin B

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cytochalasin B supplemented vitrification medium
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • indication for oocyte vitrification

Exclusion Criteria:

-

Sites / Locations

  • IbnSina IVF Center, IbnSina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cytochalasin B supplemented vitrification medium

Vitrification medium with no supplementation

Arm Description

Outcomes

Primary Outcome Measures

survival after thawing

Secondary Outcome Measures

fertilization rate
Rates of blastocyst formation and quality
Number of formed blastocyst and blastocyst with high-quality per fertilized oocytes
embryo utilisation rate
clinical pregnancy rate
ongoing pregnancy rate

Full Information

First Posted
September 17, 2018
Last Updated
August 5, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center
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1. Study Identification

Unique Protocol Identification Number
NCT03678558
Brief Title
Oocyte Vitrification Aided With Cytochalasin B
Official Title
Cytochalasin B for Oocyte Vitrification
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte vitrification.

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
612 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cytochalasin B supplemented vitrification medium
Arm Type
Experimental
Arm Title
Vitrification medium with no supplementation
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cytochalasin B supplemented vitrification medium
Intervention Description
Vitrification of human oocyte in medium supplemented with Cytochalasin B
Primary Outcome Measure Information:
Title
survival after thawing
Time Frame
6 days of culture
Secondary Outcome Measure Information:
Title
fertilization rate
Time Frame
6 days of culture
Title
Rates of blastocyst formation and quality
Description
Number of formed blastocyst and blastocyst with high-quality per fertilized oocytes
Time Frame
6 days of culture
Title
embryo utilisation rate
Time Frame
6 days of culture
Title
clinical pregnancy rate
Time Frame
three months
Title
ongoing pregnancy rate
Time Frame
12 months

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: indication for oocyte vitrification Exclusion Criteria: -
Facility Information:
Facility Name
IbnSina IVF Center, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oocyte Vitrification Aided With Cytochalasin B

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