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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2014

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.
    • Time Frame: Month 12 of the project
  • Publication of scientific reports.
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Days

Maximum Age: 7 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • Collaborator
    • Merck Serono S.A., Geneva
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paola Scaruffi, Dr – IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • Overall Official(s)
    • Paola Scaruffi, PhD, Principal Investigator, UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy

Citations Reporting on Results

Stigliani S, Anserini P, Venturini PL, Scaruffi P. Mitochondrial DNA content in embryo culture medium is significantly associated with human embryo fragmentation. Hum Reprod. 2013 Oct;28(10):2652-60. doi: 10.1093/humrep/det314. Epub 2013 Jul 25.

Stigliani S, Persico L, Lagazio C, Anserini P, Venturini PL, Scaruffi P. Mitochondrial DNA in Day 3 embryo culture medium is a novel, non-invasive biomarker of blastocyst potential and implantation outcome. Mol Hum Reprod. 2014 Dec;20(12):1238-46. doi: 10.1093/molehr/gau086. Epub 2014 Sep 17.

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