Culture MediaNCT01397136
Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
An observational study of Culture Media and DNA, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 2 to 7 days
- Conditions the study is for
- Culture Media, DNA
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Culture media from human embryos collected at day 2-7 after in-vitro fertilization.
Who may be able to join
- 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.
Who cannot join
- We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Culture Media, DNA
- Keywords
- Human embryo, Culture media, Cell-free DNA, In vitro fertilization, Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium
Measured: Month 6 of the project
Secondary outcomes (3)
Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.
Measured: Month 12 of the project
Publication of scientific reports.
Measured: Month 12 of the project
Dissemination of results by participating at national and international meetings, workshops and specific courses.
Measured: Months 3-12 of the project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Culture MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono S.A., Geneva
- Responsible party
- Principal investigator, Paola Scaruffi, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Paola Scaruffi, PhD, Principal investigator, UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397136
- Sponsor's protocol ID
- GFI2011_PS
- Status last verified
- Feb 2015
- First submitted
- 14 Jul 2011
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23887072Stigliani 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.
PubMed 25232043
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
- ClinicalTrials.gov ID
- NCT01397136
- Acronym / sponsor ID
- GFI2011_PS
- Conditions
- Culture Media, DNA
- Keywords
- Human embryo, Culture media, Cell-free DNA, In vitro fertilization, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Collaborators
- Merck Serono S.A., Geneva
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Culture media from human embryos collected at day 2-7 after in-vitro fertilization.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium
Time frame: Month 6 of the project
3 secondary outcomes
Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.
Time frame: Month 12 of the project
Publication of scientific reports.
Time frame: Month 12 of the project
Dissemination of results by participating at national and international meetings, workshops and specific courses.
Time frame: Months 3-12 of the project
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Results publication: PubMed 23887072Stigliani 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.
- Results publication: PubMed 25232043Stigliani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Scaruffi, PhD principal investigator
UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Culture Media and DNA, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium (time frame: Month 6 of the project). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01397136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.