Chromosomal AbnormalitiesNCT00614367
Chromosomal Analysis of Single Cells in Human Embryos
An observational study of Chromosomal Abnormalities, run by KU Leuven at 1 site in Belgium.
Trial summary
Optimise genetic screening of human embryos using higher resolution techniques Read more about this study
- Who is it for?
- Ages 3 to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Chromosomal Abnormalities
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2005to Jun 2008
- 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 3 to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: 3-4 day old human IVF embryos
Who may be able to join
- 3-4 day old embryos from IVF couples with both partners younger than 36 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital Leuven, Catholic University Leuven
Leuven, 3000
About this study
Optimise genetic screening of human embryos using higher resolution techniques
- Conditions
- Chromosomal Abnormalities
- Keywords
- chromosomal abnormalities in single cells
- Medical subject headings
- Chromosome Aberrations
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic constitution of single blastomeres
Measured: 3 day old embryos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionMar 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosomal AbnormalitiesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Joris Vermeesch, Prof PhD, Principal investigator, University Hospital Leuven, Catholic University LeuvenThomas D'hooghe, Prof MD PhD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614367
- Sponsor's protocol ID
- ML4102005
- Status last verified
- Jan 2008
- First submitted
- 30 Jan 2008
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromosomal Analysis of Single Cells in Human Embryos
- ClinicalTrials.gov ID
- NCT00614367
- Acronym / sponsor ID
- ML4102005
- Conditions
- Chromosomal Abnormalities
- Keywords
- chromosomal abnormalities in single cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 13 Feb 2008 (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.
Optimise genetic screening of human embryos using higher resolution techniques
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 3-4 day old human IVF embryos
Key inclusion criteria (1 listed)
- 3-4 day old embryos from IVF couples with both partners younger than 36 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genetic constitution of single blastomeres
Time frame: 3 day old embryos
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2008.
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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.
Joris Vermeesch, Prof PhD principal investigator
University Hospital Leuven, Catholic University Leuven
Thomas D'hooghe, Prof MD PhD study director
Universitaire Ziekenhuizen KU Leuven
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 Abnormalities, run by KU Leuven at 1 site in Belgium.
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 0 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 13 Feb 2008. 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 Belgium. 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?
genetic constitution of single blastomeres (time frame: 3 day old embryos). 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 13 Feb 2008.