Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
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ClinicalTrials.gov Identifier: NCT01397136
Recruitment Status :
First Posted : July 19, 2011
Last Update Posted : February 5, 2015
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Merck Serono S.A., Geneva
Information provided by (Responsible Party):
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.
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium [ Time Frame: Month 6 of the project ]
Secondary Outcome 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 ]
Biospecimen Retention: Samples With DNA
After normally fertilized oocytes will be identified, they will be transferred into Sydney IVF Cleavage Medium (Cook Medical) for culture from day 1 to day 3 (up to 8 cell stage). For a subset of embryos we will also perform culture until blastocyst stage. For this purpose, embryos will be transferred into Sydney IVF Blastocist medium (Cook Medical) from day 3 to day 5/6. We will focus on embryo development in a single embryo culture medium. Embryos will be cultured at 37°C, 6.0% CO2, 5.0% O2 into Galaxy 48R incubators (New Brunswick Scientific). At the moment of transfer of embryos into the uterine cavity, we will collect embryo culture media into DNase- and RNase-free 1.5 ml tubes (Eppendorf AG). The media will be immediately frozen and stored at -20° until nucleic acid purification.
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Layout table for eligibility information
Ages Eligible for Study:
up to 7 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Culture media from human embryos collected at day 2-7 after in-vitro fertilization.
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.
We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.