Media, Morphokinetics, and Mosaicism

University of California, San Francisco200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Embryonic Mosaicism Embryo Culture Media Embryo Morphokinetics

Interventions

EmbryoScope PlusDEVICE

All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data

GLOBAL MEDIAOTHER

Embryos will be cultured in GLOBAL media

SAGE MEDIAOTHER

Embryos will be cultured in SAGE media

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Aneuploidy Rates

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 Outcomes

Embryo Quality

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

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%.