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Genomic DNA in Human Blastocoele Fluid

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780415
First Posted: January 31, 2013
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Palini Simone, Cervesi Hospital, Cattolica, Italy
  Purpose
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 Palini Simone, 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
Bastovit
all the patients that have supernumerary embryos to vitrify at blastocyst stage
Other: blastocoele aspiration

  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • IVF patient with supernumerary embryos to vitrify at blastocyst stage

Exclusion Criteria:

  • IVF patient without blastocyst formation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780415


Locations
Italy
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
ClinicalTrials.gov Identifier: NCT01780415     History of Changes
Other Study ID Numbers: NewEra21972
First Submitted: January 28, 2013
First Posted: January 31, 2013
Last Update Posted: January 31, 2017
Last Verified: July 2016

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

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes