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Clinical Trials/NCT02359747
NCT02359747
Unknown
Not Applicable

Analysis of Human Genomic DNA in Embryo's Culture Media Targeting on a Single Gene Disease and Point Mutations

Cervesi Hospital, Cattolica, Italy2 sites in 1 country100 target enrollmentJanuary 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Single-Gene Disease
Sponsor
Cervesi Hospital, Cattolica, Italy
Enrollment
100
Locations
2
Primary Endpoint
genomic DNA in culture medium (pg)
Last Updated
5 years ago

Overview

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 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

Registry
clinicaltrials.gov
Start Date
January 12, 2020
End Date
December 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cervesi Hospital, Cattolica, Italy
Responsible Party
Principal Investigator
Principal Investigator

Palini Simone

Senior Clinica Embryologist Lab Director

Cervesi Hospital, Cattolica, Italy

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • patients with embryos that can't be cultured from day 0 (insemination day) to day 5/6 (blastocyst stage)

Outcomes

Primary Outcomes

genomic DNA in culture medium (pg)

Time Frame: 1 year

Secondary Outcomes

  • amplification of point mutation(1 year)

Study Sites (2)

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