N/A
N=254
Media, Morphokinetics, and Mosaicism
Embryonic Mosaicism · Embryo Culture Media · Embryo Morphokinetics · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT03503877 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Aneuploidy Rates — 56.1; 62.3 percentage of embryos — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EmbryoScope Plus (Device); GLOBAL MEDIA (Other); SAGE MEDIA (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aneuploidy Rates |
56.1; 62.3 | 0.07 |
| SECONDARY Embryo Quality |
45.7; 45.6 | 0.89 |
| SECONDARY Embryonic Mosaicism |
15.9; 18.9; 1.0; 2.2 | 0.54 |
| SECONDARY Embryo Morphokinetics |
28.1; 28.4; 38.5; 39.5; 40.6; 41.2 | 0.01 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03503877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.