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

Culture Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397136
• Other study ID #: GFI2011_PS
• Status: Completed
• Phase: N/A
• First received: July 14, 2011
• Last updated: February 4, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Culture Media
• DNA

Locations

Country	Name	City	State
Italy	IRCCS AOU San Martino-IST	Genova	GE

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	Merck Serono S.A., Geneva

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium		Month 6 of the project	No
Secondary	Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.		Month 12 of the project	No
Secondary	Publication of scientific reports.		Month 12 of the project	No
Secondary	Dissemination of results by participating at national and international meetings, workshops and specific courses.		Months 3-12 of the project	No