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OpenTrials
Completed

NCT Number: NCT01397136

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

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.

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Key information

Conditions

Culture Media DNA Genital Diseases Infertility Urogenital Diseases

Age range

2 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU San Martino-IST

Genova, GE, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium

    Time frame: Month 6 of the project

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Merck Serono S.A., Geneva

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 19, 2011
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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