The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy

Early Phase 1

• Conditions: Abnormal Karyotype
• Interventions: Procedure: Trophectoderm biopsy; Procedure: Blastocentisis

• Registration Number: 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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-23
• Last Update Submitted: 2016-09-23
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Study Start: 2016-10
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Couples undergoing assisted reproduction for pre-implantation genetic diagnosis

Exclusion Criteria

• Any other couples undergoing assisted reproduction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trophectoderm biopsy	Trophectoderm biopsy	Throphectoderm cells will be removed from the embryo on day 5 or 6 of development and will be subjected to genetic analysis
Blastocentisis	Blastocentisis	The blastocoelic fluid will be aspirated from the embryonic cavity on day 5 or 6 of development and will be subjected to genetic analysis

Primary Outcome Measures

Name	Time	Method
Number of blastocyst with genomic DNA present in the blastocoelic cavity	Twelve months

Trial Locations

Locations (1)

Kalliopi Loutradi; 🇬🇧 London, United Kingdom