Media, Morphokinetics, and Mosaicism (3M)

Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Embryonic Mosaicism; Embryo Culture Media; Embryo Morphokinetics
• Intervention / Treatment: Device: EmbryoScope Plus; Other: SAGE MEDIA; Other: GLOBAL MEDIA

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aneuploidy Rates	number of embryos with abnormal chromosome number over total number of embryos biopsied (%)	Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embryo Quality	Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).	2 weeks from start of IVF treatment
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%.	Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Embryo Morphokinetics	time to first and all subsequent cell cleavages	2 weeks from start of IVF treatment

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Mitchell Rosen, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Actual): November 28, 2019
• Study Completion (Actual): November 28, 2019

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 17-22331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes