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A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst

Primary Purpose

Blastocyst Disintegration

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
home made vitrification & thawing kit
commercially made vitrification & thawing kit
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blastocyst Disintegration focused on measuring vitrification, blastocysts, home-made media

Eligibility Criteria

22 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age of the patients 22-37
  • All vitrified & thawed blastocyst.
  • unexplained cases or ovarian factors for infertility.

Exclusion Criteria:

  • extremes of age
  • cases of uterine factor
  • endometriosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Home made media

    Commercial media

    Arm Description

    home made vitrification & thawing kit

    commercially available vitrification & thawing kit

    Outcomes

    Primary Outcome Measures

    blastocyst immediate survival
    The effect of Vitrification protocol on the blastocyst immediate survival

    Secondary Outcome Measures

    pregnancy rate
    clinical pregnancy rate in these cases
    live birth rate
    live birth rate of positive pregnancy cases
    Blastocyst survival at 6 hours
    The effect of Vitrification protocol on the blastocyst survival after 6 hours

    Full Information

    First Posted
    September 2, 2018
    Last Updated
    September 6, 2018
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03660904
    Brief Title
    A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst
    Official Title
    A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    June 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University

    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
    This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).
    Detailed Description
    Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blastocyst Disintegration
    Keywords
    vitrification, blastocysts, home-made media

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
    Masking
    Care ProviderInvestigator
    Masking Description
    only the investigator knew the procedure and the media provided for each case
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Home made media
    Arm Type
    Experimental
    Arm Description
    home made vitrification & thawing kit
    Arm Title
    Commercial media
    Arm Type
    Active Comparator
    Arm Description
    commercially available vitrification & thawing kit
    Intervention Type
    Biological
    Intervention Name(s)
    home made vitrification & thawing kit
    Intervention Description
    home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
    Intervention Type
    Biological
    Intervention Name(s)
    commercially made vitrification & thawing kit
    Intervention Description
    commercially available vitrification & thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
    Primary Outcome Measure Information:
    Title
    blastocyst immediate survival
    Description
    The effect of Vitrification protocol on the blastocyst immediate survival
    Time Frame
    0 hour at time of thawing
    Secondary Outcome Measure Information:
    Title
    pregnancy rate
    Description
    clinical pregnancy rate in these cases
    Time Frame
    2 weeks after transfer
    Title
    live birth rate
    Description
    live birth rate of positive pregnancy cases
    Time Frame
    9 months
    Title
    Blastocyst survival at 6 hours
    Description
    The effect of Vitrification protocol on the blastocyst survival after 6 hours
    Time Frame
    6 hours after thawing

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    blastocysts of infertile couples
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    37 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age of the patients 22-37 All vitrified & thawed blastocyst. unexplained cases or ovarian factors for infertility. Exclusion Criteria: extremes of age cases of uterine factor endometriosis

    12. IPD Sharing Statement

    Learn more about this trial

    A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst

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