Pilot Study of Discarded Blastocysts (DECODE)

February 23, 2026 updated by: Igenomix

Prospective Observational Pilot Study of Discarded Blastocysts: a Molecular Approach to Uncovering Hidden Reproductive Potential

The goal of this observational study is to determine multiomics patterns related to global embryo quality to help overcome the limitations of conventional embryo quality assessment. The main question it aims to answer is:

• Do discarded blastocysts that reach the blastocyst stage (days 5-6) show characteristic multiomics profiles which correlate with chromosomal abnormalities, providing insights into embryo viability?

For that, patients undergoing an IVF treatment will be asked to donate their clinically discarded 5/6-day embryos (those that do not meet clinical criteria to be used for reproductive purposes). Participation in the study will not interfere with the planned IVF treatment. Patient participation is limited to signature of the informed consent to donate embryos and no other study-specific procedures will be performed on participants.

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

In vitro fertilization has advanced infertility treatment, but accurately assessing embryo viability remains challenging because conventional selection methods may miss subtle molecular indicators of developmental potential. Increasing evidence shows that some embryos discarded based on morphology or developmental timing may be chromosomally normal and possess favorable molecular traits, prompting interest in multiomics analysis as a more sensitive assessment tool. Studies have demonstrated that omics patterns can distinguish chromosomally normal from abnormal embryos and correlate with key indicators of developmental competence, such as morphology, arrest status, and implantation success, with high-potential blastocysts showing distinct developmental gene signatures. The blastocyst stage is particularly critical, as inner cell mass (ICM) and trophectoderm (TE) lineages diverge, and emerging data suggest these cell types exhibit different multiomics responses to chromosomal abnormalities. However, many prior studies relied on vitrified embryos, where cryopreservation may alter multiomic profiles.

To address this limitation, this study focuses on fresh, non-vitrified blastocysts, offering a more accurate representation of embryos' intrinsic molecular states and developmental potential. Therefore, the aim of the present pilot study is to define multiomics patterns associated with euploidy, chromosomal abnormalities and embryo quality at the blastocyst stage.

Once the study is approved by the competent Research Ethics Committee, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent. To comply with the study design and the proposed hypothesis, an estimated total number of 150 patients will be recruited to obtain around 200 discarded embryos.

This is a prospective, descriptive, observational pilot study which will include all eligible discarded blastocysts donated by IVF patients from a single Norwegian centre. This site will be responsible for patients' recruitment and embryonic samples collection, while sample analysis will take place in a Central Laboratory in Spain. On day 5/6 of development, blastocysts that do not meet the standard clinical criteria to be transferred, will be donated to the study by the participants. Additionally, when possible, cumulus cells and sperm cells will also be collected. After embryo donation, 2 trophectoderm and 1 inner cell mass biopsies will be collected and analysed for multiomics profiling.

Data exported from the medical records and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation on data protection. This information will be exported to an internal database.

Participants' involvement in the study will be limited to the consent; participants will not undergo any other study specific procedures.

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 (Estimated)

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.
150

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

Study Locations

  • Norway
    • Oslo County
      • Oslo, Oslo County, Norway, 0372
        • Oslo University Hospital HF (OUS HF), Rikshospitalet
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Biba, PhD

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will involve 200 discarded embryos from approximately 150 women undergoing IVF treatment at Oslo University Hospital. The selected population will fall within the age range of 20 to 42, representing the common demographic for IVF patients.

Description

Inclusion Criteria:

  • Patients whose written informed consent approved by the Ethic Committee has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits, and any discomfort involved.
  • Patients undergoing regular IVF/ICSI cycles with fresh oocytes and embryo culture to the blastocyst stage (day 5-6 after fertilization)
  • Patients' age will be between 20-42 years of age.
  • Patients without PGT-M or PGT-SR indication.

Exclusion Criteria:

  • Patients who do not have at least one discarded blastocyst on day 5-6 of development.
  • Patients with discarded blastocysts that do not meet these criteria:
  • Presence of ICM
  • Non-degenerated

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

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.
Discarded blastocysts
All study participants will follow the same procedure. Study participation is limited to informed consent signature and donation of the clinically discarded embryos. Participants will not undergo any other study-specific procedures.
Genetic: Multiomics analysis

Donated discarded blastocysts (day 5/6) will undergo 2 TE biopsies and 1 ICM biopsy which will be analyzed for chromosomic status and multiomics profiles. Additional, when possible, cumulus cells and sper cells will also be analyzed.

After donation of the discarded embryos, participants will follow their established IVF treatment.

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
Establishment of multiomics patterns associated with euploidy, chromosomal abnormalities and embryo quality at the blastocyst stage.
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Discarded embryos will be analyzed for multiomics and bioinformatic analysis will be applied to find multiomics patterns that correlate with euploidy, chromosomal abnormalities and embryo quality.
1 day, corresponding to the Informed Consent signature date.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination of the genetic constitution of different blastocyst compartments.
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Comparison of the genetic constitution of trophectoderm (TE) and inner cell mass (ICM) biopsies from the same blastocyst.
1 day, corresponding to the Informed Consent signature date.
Determination of the incidence of chromosomally normal blastocysts with normal fertilization (2PN) that have been discarded due to poor morphology, slow development or cell degeneration.
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Chromosomic dotation of 2PN blastocysts that have been discarded (due to poor morphology, slow development or cell degeneration) will be analyzed for chromosomal status and the ratio of normal blastocysts will be calculated.
1 day, corresponding to the Informed Consent signature date.
Determination of the incidence of chromosomally normal blastocysts in blastocysts with atypical fertilization (0PN, 1PN, 3PN).
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Chromosomic dotation of atypically fertilized blastocysts (0PN, 1PN, 2PN) will be analyzed and the ratio of chromosomically normal blastocysts will be calculated.
1 day, corresponding to the Informed Consent signature date.
Exploration of the potential contamination of TE biopsies with cumulus and sperm cells and its possible impact on the accuracy of the results.
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Genetic analysis of the TE biopsies will be compared with the genetic analysis of cumulus cells and sperm cells for possible DNA contamination in the TE biopsy.
1 day, corresponding to the Informed Consent signature date.
Correlation of embryo morphokinetics parameters with the TE and ICM chromosomal status.
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Genetic analysis of the TE and ICM biopsies will be compared with embryo morphokinetics parameters to find any correlations.
1 day, corresponding to the Informed Consent signature date.
Correlation of embryo morphokinetics parameters with the TE and ICM multiomics profiles.
Time Frame: 1 day, corresponding to the Informed Consent signature date.
Multiomics profiling of the TE and ICM biopsies will be compared with embryo morphokinetics parameters to find any correlations.
1 day, corresponding to the Informed Consent signature date.
Correlation of sibling relatedness with multiomics profiles in cases with more than one embryo available per cycle
Time Frame: 1 day, corresponding to the Informed Consent signature date.
When more than one embryo is discarded from the same cycle, they will be analysed to find a possible correlation between sibling relatedness and multiomics profiles.
1 day, corresponding to the Informed Consent signature date.

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.
Igenomix

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.
Oslo University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Carmen Rubio, PhD, Vicepresident R&D Genetic Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

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 1, 2026

Primary Completion (Estimated)

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.
May 1, 2027

Study Completion (Estimated)

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.
May 1, 2027

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).
February 17, 2026

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 23, 2026

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 24, 2026

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 24, 2026

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 23, 2026

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.
February 1, 2026

More Information

Terms related to this study

Keywords

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.
  • IGX-DEC-CR-25-03

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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