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

February 4, 2015 updated by: Paola Scaruffi, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • GE
      • Genova, GE, Italy, 16132
        • IRCCS AOU San Martino-IST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Culture media from human embryos collected at day 2-7 after in-vitro fertilization.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium
Time Frame: Month 6 of the project
Month 6 of the project

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Merck Serono S.A., Geneva

Investigators

  • Principal Investigator: Paola Scaruffi, PhD, UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GFI2011_PS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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