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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this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.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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In context

Aneuploidy

73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.

This study's enrollment of 35 is below the median of 325 across 38 observational studies indexed under Aneuploidy.

Browse Aneuploidy studies →

Lead sponsor

Cervesi Hospital, Cattolica, Italy is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of Dec 2021 and a completion of Jan 2022. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2013
First posted
Jan 31, 2013
Start
Jan 2013
Primary completionEst.
Dec 2021
CompletionEst.
Jan 2022
Last update
Feb 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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Discussion

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