Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Analysis of Human Genomic DNA in Embryo's Culture Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359747
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Palini Simone, Cervesi Hospital, Cattolica, Italy

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole Genome Amplification before PCR and sequencing of the samples to find the point mutation

Condition or disease Intervention/treatment
Single-Gene Disease Genetic: Polymerase Chain Reaction and Whole Genome Amplification

Detailed Description:

Human fertilized oocytes were individually cultured from Day 1 to Day 3, and from day 3 to days 5/6, in 10 ul medium. A total of 100 samples (50 spent media from Day 3 and 50 from Day 5/6) will be use in the study.

Double-stranded DNA (dsDNA) amplifiability will be evaluated in embryos culture media by quantitative PCR on a multicopy gene target (TBC1D3). Quantification will be made with a standard curve constructed with genomic DNA (with culture media -day 3 and day5-, to take into account media inhibitory effects) TSPY1 amplification will be use to assess the presence of Y chromosome WGA followed by PCR on a single copy gene (MTHFR gene) will be performed on a subset of some samples to monitor the C677T polymorphism (genotyping by sequencing) WGA followed by PCR on a single copy gene (MTHFR) will be also performed on blastocoele fluids

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Human Genomic DNA in Embryo's Culture Media Targeting on a Single Gene Disease and Point Mutations
Actual Study Start Date : January 12, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
In Vitro Fertilization treatment
culture medium discarded after IVF treatment
 Genetic: Polymerase Chain Reaction and Whole Genome Amplification
Polymerase Chain Reaction and Whole Genome Amplification


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. genomic DNA in culture medium (pg) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. amplification of point mutation [ Time Frame: 1 year ]
    amplification of point mutation with PCR (polymerase chain reaction)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all the mediun descarted after embryos culture in vitro
Criteria

Inclusion Criteria

  • all the patients undergoing IVF treatment at Cervesi Hospital

Exclusion Criteria:

  • patients with embryos that can't be cultured from day 0 (insemination day) to day 5/6 (blastocyst stage)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359747


Contacts
Layout table for location contacts
Contact: Simone Palini +393394572101 simonepalini@yahoo.it

Locations
Layout table for location information
Italy
Cervesi Hospital Recruiting
Cattolica, Italy, 47841
Contact: Luca Galluzzi       silviadestefani@ymail.com   
cervesi Hospital Recruiting
Cattolica, Italy, 47841
Contact: silvia de stefani       silviadestefani@ymail.com   
Sponsors and Collaborators
Cervesi Hospital, Cattolica, Italy
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Palini Simone, Senior Clinica Embryologist Lab Director, Cervesi Hospital, Cattolica, Italy
ClinicalTrials.gov Identifier: NCT02359747    
Other Study ID Numbers: PGD on culture media is easy
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Keywords provided by Palini Simone, Cervesi Hospital, Cattolica, Italy:
free gDNA
culture media