The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abnormal Karyotype

Intervention / Treatment
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* Procedure: Blastocentisis
* Procedure: Trophectoderm biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples undergoing assisted reproduction for pre-implantation genetic diagnosis Exclusion Criteria: Any other couples undergoing assisted reproduction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blastocentisis<br>The blastocoelic fluid will be aspirated from the embryonic cavity on day 5 or 6 of development and will be subjected to genetic analysis | Procedure: Blastocentisis<br>* Removal of blastocoelic fluid from the blastocoelic cavity<br>|
| Active Comparator: Trophectoderm biopsy<br>Throphectoderm cells will be removed from the embryo on day 5 or 6 of development and will be subjected to genetic analysis | Procedure: Trophectoderm biopsy<br>* Removal of trophectoderm cells from the blastocyst<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blastocyst with genomic DNA present in the blastocoelic cavity |  | Twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA, Blastocyst, Human, Blastocentesis