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Clinical Trials/NCT01397136
NCT01397136
Completed
Not Applicable

Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy1 site in 1 country600 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Culture Media
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Enrollment
600
Locations
1
Primary Endpoint
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in embryo culture medium, in order to investigate whether both cell-free nucleic acid types may provide additional, reliable, predictive parameters for embryo viability and implantation potential.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Responsible Party
Principal Investigator
Principal Investigator

Paola Scaruffi

Dr

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Eligibility Criteria

Inclusion Criteria

  • We will enroll in the study only embryos obtained from fresh gametes. It is to note that we currently transfer more than one embryo (with a maximum of 3, according to patient's age) and we will follow such criteria alongside the project. Consequently, we will take into consideration this aspect in correlating DNA parameters with embryo's outcome.

Exclusion Criteria

  • We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.

Outcomes

Primary Outcomes

Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium

Time Frame: Month 6 of the project

Secondary Outcomes

  • Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.(Month 12 of the project)
  • Publication of scientific reports.(Month 12 of the project)
  • Dissemination of results by participating at national and international meetings, workshops and specific courses.(Months 3-12 of the project)

Study Sites (1)

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