Embryos With Preimplantation Genetic Testing for Aneuploidies (PGT-A) Inconclusive Result: Clinical Implications

February 1, 2021 updated by: IVI Vigo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

Double embryo transfer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group)
Collect retrospectively clinical data on reproductive outcomes
Other: Collect retrospectively clinical data on reproductive outcomes
Collect retrospectively clinical data on reproductive outcomes
Rebiopsy group:
Collect retrospectively clinical data on reproductive outcomes
Other: Collect retrospectively clinical data on reproductive outcomes
Collect retrospectively clinical data on reproductive outcomes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: Since July 2019 to December 2020
Analyze implantation rate in the groups
Since July 2019 to December 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IVI Vigo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Valenciano de Infertilidad, IVI VALENCIA
Juno Therapeutics, Inc.

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-VGO-095-EM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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