Cell-free DNA: a Non-invasive Test for Assessing Embryo Q... | NCT01397136

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

NCT01397136

Sponsor

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

Status

Completed

Last Update Posted

Feb 5, 2015Estimated

Enrollment

600Actual

Phase

Not provided

Conditions

Culture Media
DNA

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 18, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paola Scaruffi, Dr, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Merck Serono S.A., Geneva	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium		Month 6 of the project

Secondary Outcomes

Measure	Description	Time Frame
Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.		Month 12 of the project
Publication of scientific reports.		Month 12 of the project

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

7 Days

Standard Ages

Child

Study Population

Culture media from human embryos collected at day 2-7 after in-vitro fertilization.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paola Scaruffi, PhD	UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS AOU San Martino-IST		Genova	GE	16132	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23887072	Result	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.
25232043	Result	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases