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Media, Morphokinetics, and Mosaicism

NCT03503877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-12-14

Study results available
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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.

Conditions

  • Embryonic Mosaicism
  • Embryo Culture Media
  • Embryo Morphokinetics
  • Infertility

Interventions

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

OTHER

SAGE MEDIA

Embryos will be cultured in SAGE media

Sponsors & Collaborators

Principal Investigators

  • Mitchell Rosen, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2019-11-28
Completion
2019-11-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503877 on ClinicalTrials.gov