Official Title
Comparison of Genomic DNA Analysis Between Blastocoele Fluid and Trophectoderm Biopsy in Human Embryos
Brief Title
The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy
Protocol ID
NCT02915276
Lead Sponsor
Center for Reproductive an Genetic Health
Brief Summary
For the purpose of this study, the investigators will perform the removal of
trophectoderm (TE) the cells as required for the purpose of pre-implantation genetic
screening, in order to perform the genetic analysis. Additionally, the investigators will
remove the blastocoelic fluid (BF) and perform additional genetic analysis on the embryo
in order to determine the agreement of the genetics results between TE cells and BF.
Detailed Description
The human embryo (fertilised egg) develops from a single cell and goes through several
developmental stages in order to prepare for implantation inside the womb. During the
fifth and sixth day post fertilisation, the embryo becomes a blastocyst. It consists of
100-150 cells and has two cell types. The inner cell mass (ICM) will give rise to the
baby and the trophectoderm cells will become the placenta. The trophectoderm (TE) cells
surround the ICM. Following the formation of the two cell types, the TE cells start
producing fluid. The progressive accumulation of fluid leads to the formation of a cavity
that expands to form the blastocele cavity. This cavity contains fluid is known as
blastocoelic fluid (BF). The fluid can contain proteins, cells and genetic material.
Traditionally to make a genetic diagnosis or when to screen embryos for abnormal
chromosome number, cells are removed (biopsy) from the trophectoderm. In experienced
hands, this is a very safe procedure and causes minimal damage to the embryo. However,
recent studies have shown that blastocoele fluid may contain genetic material which can
be aspirated (drawn out) from the blastocole cavity (blastocentesis) and used for genetic
analysis of an embryo. This is potentially less invasive and harmful to the embryo. The
aim of this study is to compare genetic analysis obtained following blastocentesis versus
trophectoderm cell biopsy.
Enrollment Count
250 participants
Eligibility Criteria
Inclusion Criteria:
- Couples undergoing assisted reproduction for pre-implantation genetic diagnosis
Exclusion Criteria:
- Any other couples undergoing assisted reproduction
Filters
Abnormal Karyotype
EARLY_PHASE1
UNKNOWN
ADULT