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Status unknownNCT02359747Updated Feb 10, 2021

Analysis of Human Genomic DNA in Embryo's Culture Media

An observational study in Single-Gene Disease, sponsored by Cervesi Hospital, Cattolica, Italy. Status unknown at 2 sites in Italy. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Cervesi Hospital, Cattolica, Italy · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Single-Gene Disease

Keywords

  • free gDNA
  • culture media
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all the mediun descarted after embryos culture in vitro

Inclusion criteria

  • all the patients undergoing IVF treatment at Cervesi Hospital

Exclusion criteria

Exclusion Criteria:

  • patients with embryos that can't be cultured from day 0 (insemination day) to day 5/6 (blastocyst stage)
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • In Vitro Fertilization treatment

    culture medium discarded after IVF treatment

    Genetic: Polymerase Chain Reaction and Whole Genome Amplification

Interventions

  • GeneticPolymerase Chain Reaction and Whole Genome Amplification

    Polymerase Chain Reaction and Whole Genome Amplification

05

What researchers measure

Primary outcomes

  1. genomic DNA in culture medium (pg)

    Time frame: 1 year

Secondary outcomes

  1. amplification of point mutation

    amplification of point mutation with PCR (polymerase chain reaction)

    Time frame: 1 year

06

Study locations

2 of 2 sites recruiting
07

Registry details

Key details

Study ID
NCT02359747
Lead sponsor
Cervesi Hospital, Cattolica, Italy
Responsible party
Palini Simone (Senior Clinica Embryologist Lab Director, Cervesi Hospital, Cattolica, Italy) — Principal investigator
First posted
Feb 10, 2015
Start date
Jan 12, 2020
Primary completion
Nov 2021 (estimated)
Completion
Dec 2022 (estimated)
Last update
Feb 10, 2021

Study contacts

Simone Palini
Contact
simonepalini@yahoo.it
+393394572101
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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