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Status unknownNCT01780415Updated Feb 9, 2021

Genomic DNA in Human Blastocoele Fluid

An observational study in Chromosomal Aneuploidies and Single Gene Desease, sponsored by Cervesi Hospital, Cattolica, Italy. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.

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this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
35
Ages
18 Years to 40 Years
Sex
Female
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Study summary

The objective will focus on the characterization of DNA fragments present in Blastocoele fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and -subsequently- Next Generation Sequencing and aCGH approaches will be used.

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Conditions studied

  • Chromosomal Aneuploidies
  • Single Gene Desease

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Keywords

  • Blastocoele fluid
  • Human DNA
  • molecular diagnosis
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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

IVF patient with supernumerary embryos to vitrify at blastocyst stage

Inclusion criteria

  • IVF patient with supernumerary embryos to vitrify at blastocyst stage

Exclusion criteria

Exclusion Criteria:

  • IVF patient without blastocyst formation
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • Bastovit

    all the patients that have supernumerary embryos to vitrify at blastocyst stage

    Other: blastocoele aspiration

Interventions

  • Otherblastocoele aspiration
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What researchers measure

Primary outcomes

  1. Number of samples with DNA in blastocoele Fluid

    the presence of DNA will be evaluated through rtPCR

    Time frame: 6 month

Secondary outcomes

  1. Number of euploid samples

    Array CGH

    Time frame: 8 months

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Study locations

1 site
  • Cervesi Hospital IVF Unit
    Cattolica, Rimini 47841, Italy
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Registry details

Key details

Study ID
NCT01780415
Lead sponsor
Cervesi Hospital, Cattolica, Italy
Responsible party
Palini Simone (Senior Clinical Embryologist, Cervesi Hospital, Cattolica, Italy) — Principal investigator
First posted
Jan 31, 2013
Start date
Jan 2013
Primary completion
Dec 2021 (estimated)
Completion
Jan 2022 (estimated)
Last update
Feb 9, 2021

Oversight

Data monitoring committee
Yes
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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