The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy
Comparison of Genomic DNA Analysis Between Blastocoele Fluid and Trophectoderm Biopsy in Human Embryos
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2016
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedSeptember 27, 2016
September 1, 2016
5 months
September 22, 2016
September 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of blastocyst with genomic DNA present in the blastocoelic cavity
Twelve months
Study Arms (2)
Blastocentisis
ACTIVE COMPARATORThe blastocoelic fluid will be aspirated from the embryonic cavity on day 5 or 6 of development and will be subjected to genetic analysis
Trophectoderm biopsy
ACTIVE COMPARATORThrophectoderm cells will be removed from the embryo on day 5 or 6 of development and will be subjected to genetic analysis
Interventions
Eligibility Criteria
You may qualify if:
- Couples undergoing assisted reproduction for pre-implantation genetic diagnosis
You may not qualify if:
- Any other couples undergoing assisted reproduction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kalliopi Loutradi
London, W1W 5QS, United Kingdom
Related Publications (2)
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):676-683.e5. doi: 10.1016/j.fertnstert.2015.11.018. Epub 2015 Dec 1.
PMID: 26658131RESULTGianaroli 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.2014.08.021. Epub 2014 Sep 23.
PMID: 25256935RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Head of Embryology
Study Record Dates
First Submitted
September 22, 2016
First Posted
September 27, 2016
Study Start
October 1, 2016
Primary Completion
March 1, 2017
Study Completion
May 1, 2017
Last Updated
September 27, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share