An observational study in Infertility (IVF Patients), sponsored by Igenomix. Completed at 2 sites in Cyprus. Per ClinicalTrials.gov, last updated 2026-01-30.
The main objective of this study is to improve niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) to avoid the need of a biopsy to perform the genetic analysis of the embryo and to help in understanding the genetic constitution of different parts of the blastocyst (early stage of an embryo development).
For this purpose, we aim to analyses the genetic material released by the embryo to the culture medium (also called Spent Blastocyst Media, SBM) from about 200 blastocysts donated to research by participants of assisted reproduction treatments.
The results will be correlated with the ones obtained from performing the same analysis on biopsies taken from the outer (trophectoderm, TE) and the inner (inner cell mass, ICM) layer of cells in different locations to investigate the mechanisms and origin of the blastocyst genetic content released to the culture medium during preimplantation embryo development.
The study and selection of embryos before transfer is a key step for the success of infertility treatments in assisted reproduction. The current techniques applied are called preimplantation genetic testing of aneuploidies (PGT-A) and are highly sensitive and specific, although they require the retrieval of four to six cells (a biopsy) from an embryo at an early stage of development (blastocyst stage).
Nowadays, the alternatives for embryo selection given to young and healthy women or to couples that do not want to undergo PGT-A are based on studying the morphology and development of the embryos. Unfortunately, these are not reliable methods to know if the embryos have the right number of chromosomes.
A new method called non-invasive PGT-A (niPGT-A) analyses the genetic material released by the embryo to the culture medium (Spent Blastocyst Media, SBM) where the embryo grows in the IVF lab. This genetic material allows for identification of the chromosome number of the embryo. In a previous pilot study, the results of the analysis of the culture media were concordant with the results of the embryo biopsy in 85% of cases.
The current study will analyze the genetic constitution of the SBM and correlate the results of the same analysis on the inner cell mass (ICM) and trophectoderm (TE) cells taken in different locations (multifocal biopsy) to improve our understanding of the mechanisms and origin of the embryo genetic content released to the culture medium during its preimplantational development.
Once this prospective and observational 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 only after finishing their assisted reproductive treatment.
To comply with the design of this pilot study, a total number of 200 blastocysts donated to research after IVF/ICSI or PGT-A cycles has been estimated to generate enough results. After warming, blastocysts will be subjected to multifocal biopsies of TE, ICM isolation and collection of the SBM. This part of the study will be performed in the collaborating centers. Samples will be shipped to Igenomix Spain for the genetic research and further data analysis.
The expected duration of the study is 18 months. Embryos will be included in the different participating centers for an estimated period of 9 months. Participants involvement in the study is just linked to the moment of the consent form signature for the embryo donation. This study will not imply any modification of a scheduled IVF/ICSI or PGT-A cycles nor extra visits to the recruiting centers.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 230 is above 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.
Donated embryos to research from patients undergoing IVF/ICSI or PGT-A cycles will be eligible for the study after informed consent signature.
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:
Note: No exclusion criteria specific to the patients' background will be considered.
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.
Study specific procedures will start only when the potential participant couples have undergone their scheduled IVF/ICSI and/or PGT-A cycles following clinics´ standard practice to obtain blastocysts that will be vitrified. If they accept to donate the surplus blastocysts not used in their reproductive treatment to the current study by signing the informed consent, lab operators will carry out embryo warming and will select the appropriate blastocysts to go through the study protocol procedures (collection of SBM and TE/ICM biopsies). No drugs or medical devices will be used.
Genetic: niPGT-A · Genetic: Multifocal TE biopsies and ICM biopsy
After being thawed following the standard lab practice, any donated blastocyst usable for the study will be washed individually to remove any trace of cumulus DNA and will be transferred to a new culture dish with a drop of 10-15µl. Day-5 blastocysts with proper re-expansion after thawing, will be cultured overnight (≈24 hours) before media collection and TE/ICM biopsies. Day-6 blastocysts will be cultured a total of 8 hours after thawing, before media collection and TE/ICM biopsies. On day 6/7, the embryos' media will be collected with an automatic pipette for niPGT-A and additional genetic analysis. The same protocol will be used to analyze SBM and blastocyst biopsies.
For biopsy, blastocysts will be transferred to the biopsy dish and multi-focal TE biopsies will be performed in three locations related to the position of the ICM. ICM biopsies will be performed following a published protocol provided to the participant centers. ICM and TE sections will be aspirated with the use of micropipettes adapted to a micromanipulation and laser microscope system. For the genetic study of the samples, the same protocol will be used to analyze embryo biopsies and SBM.
Chromosomal status of the embryos
Concordance of the genetics results between SBM and TE and ICM biopsies samples analysis results.
Time frame: Up to 6/7 days of embryo development
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Nov 2025, 13 months.
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 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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