Abnormal KaryotypeEarly Phase 1NCT02915276
The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy
A Early Phase 1 study testing Blastocentisis and Trophectoderm biopsy in people with Abnormal Karyotype, run by Center for Reproductive an Genetic Health at 1 site in United Kingdom.
Trial summary
For the purpose of this study, the investigators will perform the removal of trophectoderm (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to perform the genetic analysis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormal Karyotype
- What is being tested?
- Blastocentisis and Trophectoderm biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to May 2017
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples undergoing assisted reproduction for pre-implantation genetic diagnosis
Who cannot join
- Any other couples undergoing assisted reproduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Genomic DNA Analysis Between Blastocoele Fluid and Trophectoderm Biopsy in Human Embryos
For the purpose of this study, the investigators will perform the removal of trophectoderm (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to perform the genetic analysis. Additionally, the investigators will remove the blastocoelic fluid (BF) and perform additional genetic analysis on the embryo in order to determine the agreement of the genetics results between TE cells and BF.
Read the detailed description
The human embryo (fertilised egg) develops from a single cell and goes through several developmental stages in order to prepare for implantation inside the womb. During the fifth and sixth day post fertilisation, the embryo becomes a blastocyst. It consists of 100-150 cells and has two cell types. The inner cell mass (ICM) will give rise to the baby and the trophectoderm cells will become the placenta. The trophectoderm (TE) cells surround the ICM. Following the formation of the two cell types, the TE cells start producing fluid. The progressive accumulation of fluid leads to the formation of a cavity that expands to form the blastocele cavity. This cavity contains fluid is known as blastocoelic fluid (BF). The fluid can contain proteins, cells and genetic material. Traditionally to make a genetic diagnosis or when to screen embryos for abnormal chromosome number, cells are removed (biopsy) from the trophectoderm. In experienced hands, this is a very safe procedure and causes minimal damage to the embryo. However, recent studies have shown that blastocoele fluid may contain genetic material which can be aspirated (drawn out) from the blastocole cavity (blastocentesis) and used for genetic analysis of an embryo. This is potentially less invasive and harmful to the embryo. The aim of this study is to compare genetic analysis obtained following blastocentesis versus trophectoderm cell biopsy.
- Conditions
- Abnormal Karyotype
- Being tested
- Blastocentisis, Trophectoderm biopsy
- Keywords
- Blastocyst, Human, DNA, Blastocentesis
- Medical subject headings
- Abnormal Karyotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlastocentisisProcedure or surgery
Removal of blastocoelic fluid from the blastocoelic cavity
Trophectoderm biopsyProcedure or surgery
Removal of trophectoderm cells from the blastocyst
| Study group | Role | What they receive |
|---|---|---|
| Blastocentisis | Active comparator | The blastocoelic fluid will be aspirated from the embryonic cavity on day 5 or 6 of development and will be subjected to genetic analysis Receives: Procedure: Blastocentisis |
| Trophectoderm biopsy | Active comparator | Throphectoderm cells will be removed from the embryo on day 5 or 6 of development and will be subjected to genetic analysis Receives: Procedure: Trophectoderm biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blastocyst with genomic DNA present in the blastocoelic cavity
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abnormal KaryotypeStudies 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
- Interventional
- Phase
- Early Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Reproductive an Genetic Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kalliopi Loutradi, Center for Reproductive an Genetic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915276
- Sponsor's protocol ID
- blatocentesesJBNKL2016
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Magli MC, Pomante A, Cafueri G, Valerio M, Crippa A, Ferraretti AP, Gianaroli L. Preimplantation genetic testing: polar bodies, blastomeres, trophectoderm cells, or blastocoelic fluid? Fertil Steril. 2016 Mar;105(3):676-683.e5. doi: 10.1016/j.fertnstert.2015.11.018. Epub 2015 Dec 1.
PubMed 26658131Gianaroli L, Magli MC, Pomante A, Crivello AM, Cafueri G, Valerio M, Ferraretti AP. Blastocentesis: a source of DNA for preimplantation genetic testing. Results from a pilot study. Fertil Steril. 2014 Dec;102(6):1692-9.e6. doi: 10.1016/j.fertnstert.2014.08.021. Epub 2014 Sep 23.
PubMed 25256935
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Genomic DNA Analysis Between Blastocoele Fluid and Trophectoderm Biopsy in Human Embryos
- ClinicalTrials.gov ID
- NCT02915276
- Acronym / sponsor ID
- blatocentesesJBNKL2016
- Conditions
- Abnormal Karyotype
- Keywords
- Blastocyst, Human, DNA, Blastocentesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Center for Reproductive an Genetic HealthIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 27 Sep 2016 (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.
For the purpose of this study, the investigators will perform the removal of trophectoderm (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to perform the genetic analysis. Additionally, the investigators will remove the blastocoelic fluid (BF) and perform additional genetic analysis on the embryo in order to determine the agreement of the genetics results between TE cells and BF.
Detailed description
The human embryo (fertilised egg) develops from a single cell and goes through several developmental stages in order to prepare for implantation inside the womb. During the fifth and sixth day post fertilisation, the embryo becomes a blastocyst. It consists of 100-150 cells and has two cell types. The inner cell mass (ICM) will give rise to the baby and the trophectoderm cells will become the placenta. The trophectoderm (TE) cells surround the ICM. Following the formation of the two cell types, the TE cells start producing fluid. The progressive accumulation of fluid leads to the formation of a cavity that expands to form the blastocele cavity. This cavity contains fluid is known as blastocoelic fluid (BF). The fluid can contain proteins, cells and genetic material. Traditionally to make a genetic diagnosis or when to screen embryos for abnormal chromosome number, cells are removed (biopsy) from the trophectoderm. In experienced hands, this is a very safe procedure and causes minimal damage to the embryo. However, recent studies have shown that blastocoele fluid may contain genetic material which can be aspirated (drawn out) from the blastocole cavity (blastocentesis) and used for genetic analysis of an embryo. This is potentially less invasive and harmful to the embryo. The aim of this study is to compare genetic analysis obtained following blastocentesis versus trophectoderm cell biopsy.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blastocentisis | Active comparator | Procedure: BlastocentisisThe blastocoelic fluid will be aspirated from the embryonic cavity on day 5 or 6 of development and will be subjected to genetic analysis |
| Trophectoderm biopsy | Active comparator | Procedure: Trophectoderm biopsyThrophectoderm cells will be removed from the embryo on day 5 or 6 of development and will be subjected to genetic analysis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Couples undergoing assisted reproduction for pre-implantation genetic diagnosis
Key exclusion criteria (1 listed)
- Any other couples undergoing assisted reproduction
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 |
|---|---|---|
| BlastocentisisRemoval of blastocoelic fluid from the blastocoelic cavity | Procedure or surgery | Blastocentisis |
| Trophectoderm biopsyRemoval of trophectoderm cells from the blastocyst | Procedure or surgery | Trophectoderm biopsy |
Primary outcome
Number of blastocyst with genomic DNA present in the blastocoelic cavity
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Results publication: PubMed 26658131Magli MC, Pomante A, Cafueri G, Valerio M, Crippa A, Ferraretti AP, Gianaroli L. Preimplantation genetic testing: polar bodies, blastomeres, trophectoderm cells, or blastocoelic fluid? Fertil Steril. 2016 Mar;105(3):676-683.e5. doi: 10.1016/j.fertnstert.2015.11.018. Epub 2015 Dec 1.
- Results publication: PubMed 25256935Gianaroli L, Magli MC, Pomante A, Crivello AM, Cafueri G, Valerio M, Ferraretti AP. Blastocentesis: a source of DNA for preimplantation genetic testing. Results from a pilot study. Fertil Steril. 2014 Dec;102(6):1692-9.e6. doi: 10.1016/j.fertnstert.2014.08.021. Epub 2014 Sep 23.
- Individual participant dataSharing planned: No
Related trials for Abnormal Karyotype
Enrolling by invitationObservational study
Clinical and Genetic Aspects in Fetuses and Children With Sex Chromosome Disorders
Sex Chromosome Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Blastocentisis and Trophectoderm biopsy in people with Abnormal Karyotype, run by Center for Reproductive an Genetic Health at 1 site in United Kingdom.
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 27 Sep 2016. 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 United Kingdom. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Paul Serhal, MD, PhD (02078372905, paul.serhal@crgh.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blastocyst with genomic DNA present in the blastocoelic cavity (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915276, which also lists 2 linked publications.
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 27 Sep 2016.