Pilot Study of Discarded Blastocysts
ConditionInfertility (IVF Patients)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-42
SponsorIgenomix
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who do not have at least one discarded blastocyst on day 5-6 of development.
Presence of ICM
Non-degenerated
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Multiomics analysis
GeneticDonated 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Discarded blastocysts1 intervention
Trial outcomes
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.
Time frame
1 day, corresponding to the Informed Consent signature date.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Igenomix
Lead sponsor
Oslo University Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: