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

NCT ID: NCT01397136

Last Updated: 2015-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Culture Media DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Days

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono S.A., Geneva

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Paola Scaruffi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paola Scaruffi, PhD

Role: PRINCIPAL_INVESTIGATOR

UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy

Locations

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IRCCS AOU San Martino-IST

Genova, GE, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 23887072 (View on PubMed)

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.

Reference Type RESULT
PMID: 25232043 (View on PubMed)

Other Identifiers

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GFI2011_PS

Identifier Type: -

Identifier Source: org_study_id

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