Back to resultsMedia, Morphokinetics, and Mosaicism (3M)
Primary Purpose
Embryonic Mosaicism, Embryo Culture Media, Embryo Morphokinetics
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EmbryoScope Plus
GLOBAL MEDIA
SAGE MEDIA
Sponsored by
About this trial
This is an interventional treatment trial for Embryonic Mosaicism
Eligibility Criteria
Inclusion Criteria:
All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.
Antral Follicle Count (AFC) >8 Male and female partner > 18 years of age
Exclusion Criteria:
Female partner age >42 years of age Cleavage stage biopsy
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
SAGE Media
GLOBAL Media
Arm Description
SAGE single-step MEDIA
LIFE GLOBAL single-step MEDIA
Outcomes
Primary Outcome Measures
Aneuploidy Rates
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
Secondary Outcome Measures
Embryo Quality
Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).
Embryonic Mosaicism
Fraction of embryos given mosaic diagnosis. Embryonic mosaicism is defined as having partial aneuploidy (20-80% aneuploid). Low-level mosaicism is defined as 20-40% whereas high-level mosaicism is defined as 40-80%.
Embryo Morphokinetics
time to first and all subsequent cell cleavages
Full Information
NCT ID
NCT03503877
First Posted
February 7, 2018
Last Updated
November 17, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03503877
Brief Title
Media, Morphokinetics, and Mosaicism
Acronym
3M
Official Title
Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
November 28, 2019 (Actual)
Study Completion Date
November 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryonic Mosaicism, Embryo Culture Media, Embryo Morphokinetics, Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
sibling embryo study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAGE Media
Arm Type
Other
Arm Description
SAGE single-step MEDIA
Arm Title
GLOBAL Media
Arm Type
Other
Arm Description
LIFE GLOBAL single-step MEDIA
Intervention Type
Device
Intervention Name(s)
EmbryoScope Plus
Intervention Description
All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
Intervention Type
Other
Intervention Name(s)
GLOBAL MEDIA
Intervention Description
Embryos will be cultured in GLOBAL media
Intervention Type
Other
Intervention Name(s)
SAGE MEDIA
Intervention Description
Embryos will be cultured in SAGE media
Primary Outcome Measure Information:
Title
Aneuploidy Rates
Description
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
Time Frame
Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Secondary Outcome Measure Information:
Title
Embryo Quality
Description
Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).
Time Frame
2 weeks from start of IVF treatment
Title
Embryonic Mosaicism
Description
Fraction of embryos given mosaic diagnosis. Embryonic mosaicism is defined as having partial aneuploidy (20-80% aneuploid). Low-level mosaicism is defined as 20-40% whereas high-level mosaicism is defined as 40-80%.
Time Frame
Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Title
Embryo Morphokinetics
Description
time to first and all subsequent cell cleavages
Time Frame
2 weeks from start of IVF treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.
Antral Follicle Count (AFC) >8 Male and female partner > 18 years of age
Exclusion Criteria:
Female partner age >42 years of age Cleavage stage biopsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Rosen, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Media, Morphokinetics, and Mosaicism
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