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Genomic DNA in Human Blastocoele Fluid

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Palini Simone, Cervesi Hospital, Cattolica, Italy
ClinicalTrials.gov Identifier:
NCT01780415
First received: January 28, 2013
Last updated: July 25, 2016
Last verified: July 2016
  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

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


Enrollment: 35
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 28, 2013
Last Updated: July 25, 2016
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 December 08, 2016