Chromosomal AneuploidiesNCT01780415
Genomic DNA in Human Blastocoele Fluid
An observational study of Chromosomal Aneuploidies and Single Gene Desease, run by Cervesi Hospital, Cattolica, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chromosomal Aneuploidies, Single Gene Desease
- What is being tested?
- blastocoele aspiration
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: IVF patient with supernumerary embryos to vitrify at blastocyst stage
Who may be able to join
- IVF patient with supernumerary embryos to vitrify at blastocyst stage
Who cannot join
- IVF patient without blastocyst formation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chromosomal Aneuploidies, Single Gene Desease
- Being tested
- blastocoele aspiration
- Keywords
- Blastocoele fluid, Human DNA, molecular diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blastocoele aspirationOther
| Study group | Role | What they receive |
|---|---|---|
| Bastovit | all the patients that have supernumerary embryos to vitrify at blastocyst stage Receives: Other: blastocoele aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of samples with DNA in blastocoele Fluid
the presence of DNA will be evaluated through rtPCR
Measured: 6 month
Secondary outcomes (1)
Number of euploid samples
Array CGH
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosomal AneuploidiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cervesi Hospital, Cattolica, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palini Simone, Cervesi Hospital, Cattolica, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780415
- Sponsor's protocol ID
- NewEra21972
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2013
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic DNA in Human Blastocoele Fluid
- ClinicalTrials.gov ID
- NCT01780415
- Acronym / sponsor ID
- NewEra21972
- Conditions
- Chromosomal Aneuploidies, Single Gene Desease
- Keywords
- Blastocoele fluid, Human DNA, molecular diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cervesi Hospital, Cattolica, ItalyUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bastovit | – | Other: blastocoele aspirationall the patients that have supernumerary embryos to vitrify at blastocyst stage |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- IVF patient with supernumerary embryos to vitrify at blastocyst stage
Key inclusion criteria (1 listed)
- IVF patient with supernumerary embryos to vitrify at blastocyst stage
Key exclusion criteria (1 listed)
- IVF patient without blastocyst formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blastocoele aspiration | Other | Bastovit |
Primary outcome
Number of samples with DNA in blastocoele Fluid
Time frame: 6 month
the presence of DNA will be evaluated through rtPCR
1 secondary outcome
Number of euploid samples
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chromosomal Aneuploidies and Single Gene Desease, run by Cervesi Hospital, Cattolica, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of samples with DNA in blastocoele Fluid (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.