Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Aneuploidy Rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Time Frame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
Secondary Outcomes
- Embryo Quality(2 weeks from start of IVF treatment)
- Embryo Morphokinetics(2 weeks from start of IVF treatment)
- Embryonic Mosaicism(Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment)