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Oocyte Vitrification Aided With Latrunculin A

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Latrunculin A 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 cryopreservation

Exclusion Criteria:

-

Sites / Locations

  • Banon Assiut
  • Qena Fertility Center
  • IbnSina IVF Center, IbnSina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Latrunculin A 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 high-quality blastocysts per fertilized oocytes
embryo utilization rate
Number of utilized embryos per fertilized oocytes
clinical pregnancy rate
Number of pregnant women with fetal pulsation per recruited cycles
ongoing pregnancy rate

Full Information

First Posted
September 17, 2018
Last Updated
July 14, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center
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1. Study Identification

Unique Protocol Identification Number
NCT03678571
Brief Title
Oocyte Vitrification Aided With Latrunculin A
Official Title
Latrunculin A for Oocyte Vitrification
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 15, 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 cytoskeleton Stabilizer the Latrunculin A 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
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latrunculin A supplemented vitrification medium
Arm Type
Experimental
Arm Title
Vitrification medium with no supplementation
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Latrunculin A supplemented vitrification medium
Intervention Description
Vitrification of human oocyte in medium supplemented with Latrunculin A
Primary Outcome Measure Information:
Title
survival after thawing
Time Frame
6 days after thawing
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 high-quality blastocysts per fertilized oocytes
Time Frame
6 days of culture
Title
embryo utilization rate
Description
Number of utilized embryos per fertilized oocytes
Time Frame
6 days of culture
Title
clinical pregnancy rate
Description
Number of pregnant women with fetal pulsation per recruited cycles
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 cryopreservation Exclusion Criteria: -
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt

12. IPD Sharing Statement

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Oocyte Vitrification Aided With Latrunculin A

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