An observational study in Infertility (IVF Patients), sponsored by Igenomix. Recruiting at 1 site in Norway. Open to female participants aged 20 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Igenomix (part of Vitrolife) · Observational
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:
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.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →Igenomix is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
First submitted after Igenomix became part of Vitrolife.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Establishment of multiomics patterns associated with euploidy, chromosomal abnormalities and embryo quality at the blastocyst stage.
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.
Time frame: 1 day, corresponding to the Informed Consent signature date.
Determination of the genetic constitution of different blastocyst compartments.
Comparison of the genetic constitution of trophectoderm (TE) and inner cell mass (ICM) biopsies from the same blastocyst.
Time frame: 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.
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.
Time frame: 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).
Chromosomic dotation of atypically fertilized blastocysts (0PN, 1PN, 2PN) will be analyzed and the ratio of chromosomically normal blastocysts will be calculated.
Time frame: 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.
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.
Time frame: 1 day, corresponding to the Informed Consent signature date.
Correlation of embryo morphokinetics parameters with the TE and ICM chromosomal status.
Genetic analysis of the TE and ICM biopsies will be compared with embryo morphokinetics parameters to find any correlations.
Time frame: 1 day, corresponding to the Informed Consent signature date.
Correlation of embryo morphokinetics parameters with the TE and ICM multiomics profiles.
Multiomics profiling of the TE and ICM biopsies will be compared with embryo morphokinetics parameters to find any correlations.
Time frame: 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
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.
Time frame: 1 day, corresponding to the Informed Consent signature date.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for May 2027, 14 months after the start.
Of 242 observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 100. This study's planned 14 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Feb 2026 → Mar 2026, on Nov 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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