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Media, Morphokinetics, and Mosaicism (3M)

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ClinicalTrials.gov Identifier: NCT03503877
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Embryonic Mosaicism Embryo Culture Media Embryo Morphokinetics Infertility Device: EmbryoScope Plus Other: GLOBAL MEDIA Other: SAGE MEDIA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: sibling embryo study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : November 28, 2019
Actual Study Completion Date : November 28, 2019
Arms and Interventions
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Arm Intervention/treatment
SAGE Media
SAGE single-step MEDIA
 Device: EmbryoScope Plus
All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data

Other: SAGE MEDIA
Embryos will be cultured in SAGE media
GLOBAL Media
LIFE GLOBAL single-step MEDIA
 Device: EmbryoScope Plus
All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data

Other: GLOBAL MEDIA
Embryos will be cultured in GLOBAL media


Outcome Measures
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Primary Outcome Measures :
  1. aneuploidy rates [ Time Frame: 2 weeks ]
    number of embryos with abnormal chromosome number over total number of embryos biopsied


Secondary Outcome Measures :
  1. embryo quality [ Time Frame: 2 weeks ]
    fraction of freezable quality embryos (6c or greater, grades 1-2 for symmetry and fragmentation)

  2. embryonic mosaicism [ Time Frame: 2 weeks ]
    fraction of embryos defined as mosiac (number of embryos with partial aneuploidy over total number of embryos biopsied)

  3. embryo morphokinetics [ Time Frame: 2 weeks ]
    time of first and subsequent cleavage, time between cleavages


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503877


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Mitchell Rosen, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03503877    
Other Study ID Numbers: 17-22331
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infertility