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The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy

Comparison of Genomic DNA Analysis Between Blastocoele Fluid and Trophectoderm Biopsy in Human Embryos

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02915276
Enrollment
250
Registered
2016-09-27
Start date
2016-10-31
Completion date
2017-05-31
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Karyotype

Keywords

Blastocyst, Human, DNA, Blastocentesis

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.

Interventions

PROCEDUREBlastocentisis

Removal of blastocoelic fluid from the blastocoelic cavity

Removal of trophectoderm cells from the blastocyst

Sponsors

Center for Reproductive an Genetic Health
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Couples undergoing assisted reproduction for pre-implantation genetic diagnosis

Exclusion criteria

* Any other couples undergoing assisted reproduction

Design outcomes

Primary

MeasureTime frame
Number of blastocyst with genomic DNA present in the blastocoelic cavityTwelve months

Countries

United Kingdom

Contacts

Primary ContactPaul Serhal, MD, PhD
paul.serhal@crgh.co.uk02078372905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026