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

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ClinicalTrials.gov Identifier: NCT01397136
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : February 5, 2015
Sponsor:
Collaborator:
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

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.

Condition or disease
Culture Media DNA

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014



Primary Outcome Measures :
  1. Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium [ Time Frame: Month 6 of the project ]

Secondary Outcome Measures :
  1. Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium. [ Time Frame: Month 12 of the project ]
  2. Publication of scientific reports. [ Time Frame: Month 12 of the project ]
  3. 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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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Culture media from human embryos collected at day 2-7 after in-vitro fertilization.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397136


Locations
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Italy
IRCCS AOU San Martino-IST
Genova, GE, Italy, 16132
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Merck Serono S.A., Geneva
Investigators
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Principal Investigator: Paola Scaruffi, PhD UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy

Publications of Results:
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Responsible Party: Paola Scaruffi, Dr, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT01397136     History of Changes
Other Study ID Numbers: GFI2011_PS
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Keywords provided by Paola Scaruffi, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
Human embryo
Culture media
Cell-free DNA
In vitro fertilization
Infertility