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Genomic DNA in Human Blastocoele Fluid

This study is currently recruiting participants.
Verified January 2013 by Cervesi Hospital, Cattolica, Italy
Sponsor:
Information provided by (Responsible Party):
Palini Simone, Cervesi Hospital, Cattolica, Italy
ClinicalTrials.gov Identifier:
NCT01780415
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    the presence of DNA will be evaluated through rtPCR


Secondary Outcome Measures:
  • Number of euploid samples [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Array CGH


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780415

Contacts
Contact: Simone Palini, Biologist 00393394572101 simonepalini@yahoo.it

Locations
Italy
Cervesi Hospital IVF Unit Recruiting
Cattolica, Rimini, Italy, 47841
Contact: Silvia De Stefani     320 1111937     silviadestefani@ymail.com    
Sponsors and Collaborators
Cervesi Hospital, Cattolica, Italy
  More Information

No publications provided

Responsible Party: Palini Simone, Senior Clinical Embryologist, Cervesi Hospital, Cattolica, Italy
ClinicalTrials.gov Identifier: NCT01780415     History of Changes
Other Study ID Numbers: NewEra21972
Study First Received: January 28, 2013
Last Updated: January 30, 2013
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013