NCT01397136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

July 14, 2011

Last Update Submit

February 4, 2015

Conditions

Culture MediaDNA

Keywords

Human embryoCulture mediaCell-free DNAIn vitro fertilizationInfertility

Outcome Measures

Primary Outcomes (1)

  • Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium

    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.

    Month 12 of the project

  • Publication of scientific reports.

    Month 12 of the project

  • Dissemination of results by participating at national and international meetings, workshops and specific courses.

    Months 3-12 of the project

Eligibility Criteria

Age2 Days - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS AOU San Martino-IST

Genova, GE, 16132, Italy

Location

Related 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.

    PMID: 23887072RESULT

  • 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.

    PMID: 25232043RESULT

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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Paola Scaruffi, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

IT(1)