Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono S.A., Geneva
Information provided by (Responsible Party):
Paola Scaruffi, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01397136
First received: July 14, 2011
Last updated: February 4, 2015
Last verified: February 2015
  Purpose

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.


Condition
Culture Media
DNA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality

Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium [ Time Frame: Month 6 of the project ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium. [ Time Frame: Month 12 of the project ] [ Designated as safety issue: No ]
  • Publication of scientific reports. [ Time Frame: Month 12 of the project ] [ Designated as safety issue: No ]
  • Dissemination of results by participating at national and international meetings, workshops and specific courses. [ Time Frame: Months 3-12 of the project ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

After normally fertilized oocytes will be identified, they will be transferred into Sydney IVF Cleavage Medium (Cook Medical) for culture from day 1 to day 3 (up to 8 cell stage). For a subset of embryos we will also perform culture until blastocyst stage. For this purpose, embryos will be transferred into Sydney IVF Blastocist medium (Cook Medical) from day 3 to day 5/6. We will focus on embryo development in a single embryo culture medium. Embryos will be cultured at 37°C, 6.0% CO2, 5.0% O2 into Galaxy 48R incubators (New Brunswick Scientific). At the moment of transfer of embryos into the uterine cavity, we will collect embryo culture media into DNase- and RNase-free 1.5 ml tubes (Eppendorf AG). The media will be immediately frozen and stored at -20° until nucleic acid purification.


Enrollment: 600
Study Start Date: July 2011
Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397136

Locations
Italy
IRCCS AOU San Martino-IST
Genova, GE, Italy, 16132
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Merck Serono S.A., Geneva
Investigators
Principal Investigator: Paola Scaruffi, PhD UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy
  More Information

Publications:
Responsible Party: Paola Scaruffi, Dr, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT01397136     History of Changes
Other Study ID Numbers: GFI2011_PS
Study First Received: July 14, 2011
Last Updated: February 4, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
Human embryo
Culture media
Cell-free DNA
In vitro fertilization
Infertility

ClinicalTrials.gov processed this record on March 03, 2015