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

N/ACompletedNCT01397136

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy600 enrolled

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

OBSERVATIONAL

Enrollment

600

Conditions

Culture Media DNA

Eligibility

Sex: ALLMin age: 2 DaysMax age: 7 Days

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS AOU San Martino-IST

Genova, GE, Italy

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.

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

Data from ClinicalTrials.gov

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