Pilot Study of Discarded Blastocysts

NCT07429097 | Not Yet Recruiting

• 1 other identifier: IGX-DEC-CR-25-03
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility (IVF Patients)

Keywords

blastocyst; aneuploidy; inner cell mass; PGT-A; trophectoderm

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day, corresponding to the Informed Consent signature date.

Secondary Outcomes (7)

• Determination of the genetic constitution of different blastocyst compartments.

  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.

  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).

  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.

  1 day, corresponding to the Informed Consent signature date.

• Correlation of embryo morphokinetics parameters with the TE and ICM chromosomal status.

  1 day, corresponding to the Informed Consent signature date.

Study Arms (1)

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

Interventions

Multiomics analysis GENETIC

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.

Discarded blastocysts

Eligibility Criteria

• Age: 20 Years - 42 Years
• Gender Eligibility Details: All of them.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Igenomix: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital HF (OUS HF), Rikshospitalet

Oslo, Oslo County, 0372, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Embryo biopsies (2 trophectoderm biopsies and 1 inner cell mass biopsy) from 200 discarded day5-6 blastocysts that will be analyzed for multiomics profiles. Additionally, when possible, cumuls cells and sperm cells will also be collected for multiomics analysis.

MeSH Terms

Conditions

Infertility; Aneuploidy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Rubio, PhD

  Vicepresident R&D Genetic Services

  STUDY CHAIR

Central Study Contacts

Carlos Gómez De La Cruz, PhD

CONTACT

(+34) 963905310; carlos.gomez@vitrolifegroup.com

Esperanza Irles Vidal, PhD

CONTACT

esperanza.irles@vitrolifegroup.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)