Embryo DisorderNCT04734769
Embryos With Preimplantation Genetic Testing for Aneuploidies (PGT-A) Inconclusive Result: Clinical Implications
An observational study of Embryo Disorder, run by IVI Vigo.
Trial summary
One of the most remarkable improvements in trophoectoderm cells biopsy is the robustness of diagnosis as result of analyzing multiple cells. However, there is a proportion of embryos that lack of diagnosis due to amplification failure or inconclusive results ranging between 0,4% and 6%. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Embryo Disorder
- What is being tested?
- Collect retrospectively clinical data on reproductive outcomes
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2021to 25 Nov 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 45 years
- Women only
- Adult
Study population: All patients with indication of PGT-A (advanced maternal age, male factor, recurrent pregnancy loss, recurrent implantation failure, previous aneuploidy pregnancy) with differed single embryo transfer.
Who may be able to join
- Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group):
- Women age 18-45 years.
- PGT-A Indication.
- All embryos with informative results.
- Women age 18-45 years.
- PGT-A Indication.
Show all 10Show fewer
- At least one embryo result with lack of diagnosis.
- At least one rebiopsied embryo.
- At least one euploid result from rebiopsied embryo.
- Single embryo transfer.
Who cannot join
- Double embryo transfer
Trial locations and contacts
No sites are listed yet.
About this study
One of the most remarkable improvements in trophoectoderm cells biopsy is the robustness of diagnosis as result of analyzing multiple cells. However, there is a proportion of embryos that lack of diagnosis due to amplification failure or inconclusive results ranging between 0,4% and 6%. Information about embryo repeated biopsy after an inconclusive result in a first biopsy is very scarce. No specific conclusions can be drawn, due to the limited information currently available concerning reproductive outcomes for patients who had embryo transfer after a second biopsy, due to a first one having an inconclusive result. Investigators purpose a multicenter retrospective observational study with the aim to evaluate the reproductive potential of re-biopsied blastocyst with inconclusive results on preimplantation genetic screening for aneuploidy (PGT-A) using the implantation rate (IR) and ongoing pregnancy rate (OPR) as principal variables.
Read the detailed description
The main objective of assisted reproduction technologies (ART) is to achieve a healthy live newborn. The selection of an euploid embryo using PGT-A, offers theoretical advantages including increased implantation rate, reduced abortion rate, and reduces the time to achieve an ongoing pregnancy.
Certain advances in ART such as vitrification or improvement in culture media makes safer the PGT-A procedure. As a result of these improvements, embryo biopsy has been driven from blastomere to trophectoderm biopsy at blastocyst stage for preimplantional genetic testing for aneuploidy analysis (PGT-A 2.0) and it is now the method of choice for PGT-A in many centers. Trophectoderm biopsy presents advantages over the use of blastomere biopsy: 1. It allows obtaining around 6-10 cells without reducing the potential for pre-embryo development or its ability to implant. 2. Greater strength in the results, since it reduces false diagnoses associated with factors such as mosaicism. 3. It allows a combined study for monogenic mutations, aneuploidy screening and / or structural alterations.
The frequency of inconclusive results in PGT-A varies depending on the embryonic stage used, with values of 9-10% of the total embryos analyzed for single blastomere biopsy and between 2-6% when trophectoderm cells are biopsied.
These inconclusive results, mainly in couples without euploid embryos available to transfer, cause them uncertainty and disappointment. In these situations, it is advisable to guide patients in making decisions about what to do with these pre-embryos through genetic counselling. Patients must decide if they wish to reject them, to transfer them without the certainty of a reliable diagnosis or to re-analyze them. Scientific literature reporting these types of inconclusive results and that give advice about its possible etiology are scarce. There is no clear evidence about the impact of double biopsy, double vitrification-warming or if transferring embryos with inconclusive results, is safe for achieving a healthy newborn. The objective of this review is to learn from the published studies about the safety of embryo re-analysis and its potential reproductive outcome when there are embryos with inconclusive results after PGT, in order to offer adequate counselling for patients.
- Conditions
- Embryo Disorder
- Being tested
- Collect retrospectively clinical data on reproductive outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect retrospectively clinical data on reproductive outcomesOther
Collect retrospectively clinical data on reproductive outcomes
| Study group | Role | What they receive |
|---|---|---|
| Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group) | Collect retrospectively clinical data on reproductive outcomes Receives: Other: Collect retrospectively clinical data on reproductive outcomes | |
| Rebiopsy group: | Collect retrospectively clinical data on reproductive outcomes Receives: Other: Collect retrospectively clinical data on reproductive outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Analyze implantation rate in the groups
Measured: Since July 2019 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start20 Feb 2021 (estimated)
- Primary completion21 Feb 2021 (estimated)
- Study completion25 Nov 2022 (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 Embryo DisorderStudies 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Responsible party
- Sponsor
- Investigators
- Elkin Muñoz, Study director, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734769
- Sponsor's protocol ID
- 2011-VGO-095-EM
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cobo A, Castello D, Vallejo B, Albert C, de los Santos JM, Remohi J. Outcome of cryotransfer of embryos developed from vitrified oocytes: double vitrification has no impact on delivery rates. Fertil Steril. 2013 May;99(6):1623-30. doi: 10.1016/j.fertnstert.2013.01.106. Epub 2013 Feb 14.
PubMed 23415972Chen HH, Huang CC, Cheng EH, Lee TH, Chien LF, Lee MS. Optimal timing of blastocyst vitrification after trophectoderm biopsy for preimplantation genetic screening. PLoS One. 2017 Oct 5;12(10):e0185747. doi: 10.1371/journal.pone.0185747. eCollection 2017.
PubMed 28982142
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryos With Preimplantation Genetic Testing for Aneuploidies (PGT-A) Inconclusive Result: Clinical Implications
- ClinicalTrials.gov ID
- NCT04734769
- Acronym / sponsor ID
- 2011-VGO-095-EM
- Conditions
- Embryo Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Study start
- 20 Feb 2021 (estimated)
- Primary completion
- 21 Feb 2021 (estimated)
- Study completion
- 25 Nov 2022 (estimated)
- First posted
- 2 Feb 2021 (actual)
- 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.
One of the most remarkable improvements in trophoectoderm cells biopsy is the robustness of diagnosis as result of analyzing multiple cells. However, there is a proportion of embryos that lack of diagnosis due to amplification failure or inconclusive results ranging between 0,4% and 6%. Information about embryo repeated biopsy after an inconclusive result in a first biopsy is very scarce. No specific conclusions can be drawn, due to the limited information currently available concerning reproductive outcomes for patients who had embryo transfer after a second biopsy, due to a first one having an inconclusive result. Investigators purpose a multicenter retrospective observational study with the aim to evaluate the reproductive potential of re-biopsied blastocyst with inconclusive results on preimplantation genetic screening for aneuploidy (PGT-A) using the implantation rate (IR) and ongoing pregnancy rate (OPR) as principal variables.
Detailed description
The main objective of assisted reproduction technologies (ART) is to achieve a healthy live newborn. The selection of an euploid embryo using PGT-A, offers theoretical advantages including increased implantation rate, reduced abortion rate, and reduces the time to achieve an ongoing pregnancy.
Certain advances in ART such as vitrification or improvement in culture media makes safer the PGT-A procedure. As a result of these improvements, embryo biopsy has been driven from blastomere to trophectoderm biopsy at blastocyst stage for preimplantional genetic testing for aneuploidy analysis (PGT-A 2.0) and it is now the method of choice for PGT-A in many centers. Trophectoderm biopsy presents advantages over the use of blastomere biopsy: 1. It allows obtaining around 6-10 cells without reducing the potential for pre-embryo development or its ability to implant. 2. Greater strength in the results, since it reduces false diagnoses associated with factors such as mosaicism. 3. It allows a combined study for monogenic mutations, aneuploidy screening and / or structural alterations.
The frequency of inconclusive results in PGT-A varies depending on the embryonic stage used, with values of 9-10% of the total embryos analyzed for single blastomere biopsy and between 2-6% when trophectoderm cells are biopsied.
These inconclusive results, mainly in couples without euploid embryos available to transfer, cause them uncertainty and disappointment. In these situations, it is advisable to guide patients in making decisions about what to do with these pre-embryos through genetic counselling. Patients must decide if they wish to reject them, to transfer them without the certainty of a reliable diagnosis or to re-analyze them. Scientific literature reporting these types of inconclusive results and that give advice about its possible etiology are scarce. There is no clear evidence about the impact of double biopsy, double vitrification-warming or if transferring embryos with inconclusive results, is safe for achieving a healthy newborn. The objective of this review is to learn from the published studies about the safety of embryo re-analysis and its potential reproductive outcome when there are embryos with inconclusive results after PGT, in order to offer adequate counselling for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group) | – | Other: Collect retrospectively clinical data on reproductive outcomesCollect retrospectively clinical data on reproductive outcomes |
| Rebiopsy group: | – | Other: Collect retrospectively clinical data on reproductive outcomesCollect retrospectively clinical data on reproductive outcomes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All patients with indication of PGT-A (advanced maternal age, male factor, recurrent pregnancy loss, recurrent implantation failure, previous aneuploidy pregnancy) with differed single embryo transfer.
Key inclusion criteria (10 listed)
- Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group):
- Women age 18-45 years.
- PGT-A Indication.
- All embryos with informative results.
- Women age 18-45 years.
Key exclusion criteria (1 listed)
- Double embryo transfer
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 |
|---|---|---|
| Collect retrospectively clinical data on reproductive outcomesCollect retrospectively clinical data on reproductive outcomes | Other | Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group), Rebiopsy group: |
Primary outcome
Implantation rate
Time frame: Since July 2019 to December 2020
Analyze implantation rate in the groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 23415972Cobo A, Castello D, Vallejo B, Albert C, de los Santos JM, Remohi J. Outcome of cryotransfer of embryos developed from vitrified oocytes: double vitrification has no impact on delivery rates. Fertil Steril. 2013 May;99(6):1623-30. doi: 10.1016/j.fertnstert.2013.01.106. Epub 2013 Feb 14.
- Background: PubMed 28982142Chen HH, Huang CC, Cheng EH, Lee TH, Chien LF, Lee MS. Optimal timing of blastocyst vitrification after trophectoderm biopsy for preimplantation genetic screening. PLoS One. 2017 Oct 5;12(10):e0185747. doi: 10.1371/journal.pone.0185747. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Elkin Muñoz study director
IVI Vigo
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Disorder, run by IVI Vigo.
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 10 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elkin Muñoz (986021860, elkin.munoz@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: Since July 2019 to December 2020). 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 NCT04734769, 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 2 Feb 2021.