Viewing Study NCT02359747



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Last Modification Date: 2024-10-26 @ 11:38 AM
Study NCT ID: NCT02359747
Status: UNKNOWN
Last Update Posted: 2021-02-10
First Post: 2015-02-03

Brief Title: Analysis of Human Genomic DNA in Embryos Culture Media
Sponsor: Cervesi Hospital Cattolica Italy
Organization: Cervesi Hospital Cattolica Italy

Study Overview

Official Title: Analysis of Human Genomic DNA in Embryos Culture Media Targeting on a Single Gene Disease and Point Mutations
Status: UNKNOWN
Status Verified Date: 2021-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Human fertilized oocytes were individually cultured from Day 1 to Day 3 and from day 3 to days 56 in 10 ul medium A total of 100 samples 50 spent media from Day 3 and 50 from Day 56 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None