The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy

Abnormal Karyotype Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02915276
• Other study ID #: blatocentesesJBNKL2016
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 22, 2016
• Last updated: September 23, 2016
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2016
• Source: Center for Reproductive an Genetic Health
• Contact: Paul Serhal, MD, PhD
• Phone: 02078372905
• Email: paul.serhal[@]crgh.co.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Couples undergoing assisted reproduction for pre-implantation genetic diagnosis

Exclusion Criteria:

• Any other couples undergoing assisted reproduction

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abnormal Karyotype

Intervention

Procedure:
• Blastocentisis
Removal of blastocoelic fluid from the blastocoelic cavity
• Trophectoderm biopsy
Removal of trophectoderm cells from the blastocyst

Locations

Country	Name	City	State
United Kingdom	Kalliopi Loutradi	London

Sponsors (1)

Lead Sponsor	Collaborator
Center for Reproductive an Genetic Health

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Gianaroli L, Magli MC, Pomante A, Crivello AM, Cafueri G, Valerio M, Ferraretti AP. Blastocentesis: a source of DNA for preimplantation genetic testing. Results from a pilot study. Fertil Steril. 2014 Dec;102(6):1692-9.e6. doi: 10.1016/j.fertnstert.2014.0 — View Citation

Magli MC, Pomante A, Cafueri G, Valerio M, Crippa A, Ferraretti AP, Gianaroli L. Preimplantation genetic testing: polar bodies, blastomeres, trophectoderm cells, or blastocoelic fluid? Fertil Steril. 2016 Mar;105(3):676-83.e5. doi: 10.1016/j.fertnstert.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blastocyst with genomic DNA present in the blastocoelic cavity		Twelve months	No