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Genomic DNA in Human Blastocoele Fluid

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Palini Simone, Cervesi Hospital, Cattolica, Italy Identifier:
First received: January 28, 2013
Last updated: January 30, 2017
Last verified: July 2016
The objective will focus on the characterization of DNA fragments present in Blastocoele fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and -subsequently- Next Generation Sequencing and aCGH approaches will be used.

Condition Intervention
Chromosomal Aneuploidies
Single Gene Desease
Other: blastocoele aspiration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other

Further study details as provided by Cervesi Hospital, Cattolica, Italy:

Primary Outcome Measures:
  • Number of samples with DNA in blastocoele Fluid [ Time Frame: 6 month ]
    the presence of DNA will be evaluated through rtPCR

Secondary Outcome Measures:
  • Number of euploid samples [ Time Frame: 8 months ]
    Array CGH

Enrollment: 35
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all the patients that have supernumerary embryos to vitrify at blastocyst stage
Other: blastocoele aspiration


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IVF patient with supernumerary embryos to vitrify at blastocyst stage

Inclusion Criteria:

  • IVF patient with supernumerary embryos to vitrify at blastocyst stage

Exclusion Criteria:

  • IVF patient without blastocyst formation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01780415

Cervesi Hospital IVF Unit
Cattolica, Rimini, Italy, 47841
Sponsors and Collaborators
Cervesi Hospital, Cattolica, Italy
  More Information

Responsible Party: Palini Simone, Senior Clinical Embryologist, Cervesi Hospital, Cattolica, Italy Identifier: NCT01780415     History of Changes
Other Study ID Numbers: NewEra21972
Study First Received: January 28, 2013
Last Updated: January 30, 2017

Keywords provided by Cervesi Hospital, Cattolica, Italy:
Blastocoele fluid
Human DNA
molecular diagnosis

Additional relevant MeSH terms:
Chromosome Aberrations
Pathologic Processes processed this record on May 23, 2017