An interventional study of niPGT-A and Morphology criteria in Aneuploidy, Chromosome Abnormality and Infertility, sponsored by Igenomix. Terminated at 8 sites in 5 countries. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Igenomix (part of Vitrolife) · Not applicable, Interventional, and Diagnostic
Chromosomal aneuploidies are linked with spontaneous miscarriages and abnormal offspring in human pregnancies. In addition, some types of aneuploidies are reported to prevent implantation. Thus, there is a need to identify the embryos with highest implantation potential on in vitro fertilization (IVF) programs.
Since embryo morphology and kinetics have a weak association with embryo ploidy, trophectoderm biopsy plus Next-Generation Sequencing (NGS) is becoming a very popular approach to determine the embryo chromosomal status. This technique is called Preimplantation Genetic Testing for Aneuploidy (PGT-A). Although shown to be efficient, it is invasive for the embryo, requires specific technical skills and it remains expensive. Therefore, the development of a non-invasive, rapid and cheaper method for assessing embryo ploidy status would represent a progress in the field of IVF.
The non-invasive approach has been explored by some groups that analyzed the Spent Blastocyst Medium (SBM) where the embryo was incubated up to the time of transfer or freezing. In daily routine, this media is discarded after finishing the culture of the embryo. Importantly, though, this media reportedly contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo.
On the basis of that, the hypothesis of this study is that embryo prioritization according to the analysis of the embryonic cfDNA in the SBM could improve ongoing pregnancy rate in 10 percentual points compared to standard blastocyst transfer based on morphology.
Current Preimplantation Genetic Testing for Aneuploidy (PGT-A) techniques analyze the full chromosome content of a single or few cells with high sensitivity and specificity using Next-Generation Sequencing (NGS). Although shown to be efficient, the technique suffers from some limitations. It requires an embryo biopsy, specific technical skills and it still remains expensive. Therefore, non-invasive techniques for assessing embryo ploidy status are sought as an alternative. Such non-invasive approaches would have various advantages over current strategies, including the elimination of a costly micromanipulation biopsy procedure and the avoidance of risks associated with cell removal. Furthermore, it would be more advantageous, especially for those patients who undergo in vitro fertilization (IVF) treatment but do not have PGT-A indication or they are not willing to have their embryos tested with invasive techniques.
One of the recent advances in the field is the identification of embryonic cell-free DNA (cfDNA) during embryo culture in the lab. It is released to the culture drop (SBM) and represents the chromosome content of the embryo. In a recent pilot study, we analyzed the concordance rates between trophectoderm (TE) biopsy and SBM. In SBM collected on day 6/7 of development, the results were concordant with TE biopsies in 84% of samples, with a false-positive rate of 8.6% and a false-negative rate of 2.5%. These findings are encouraging and were the base for the design of the current RCT study.
The main objective of this study is to evaluate the potential clinical benefits of a new non-invasive method for PGT-A, based on the analysis of the embryonic cfDNA released into SBM.
Considering a dropout rate of around 30% (mainly due to treatment or monitoring failures and no day 6/7 blastocysts to transfer), a total of 1108 participants will be randomized before the ovum pick-up. They will be allocated on a balanced way (1:1 ratio) in one of the two arms: 1) Deferred transfer of a single frozen day 6/7 blastocyst which selection was based on the chromosomal status according to the analysis of the SBM; 2) Deferred transfer of a single frozen day 6/7 blastocyst which selection was based on standard embryo morphology (Gardner criteria). Reproductive outcomes (defined following The International Glossary on Infertility and Fertility Care, 2017) will be compared between the two groups.
As this is an open study, both physician and patient will receive the results of the analysis of the culture media. The control group will also have access to these results but at the end of their participation in the study and if she or her physician request it. Additional tests of chromosomal abnormalities (NIPT and POC) could be performed (with no extra cost) under request to ensure patient´s safety and efficacy of the SBM analysis.
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. This information will be exported to an electronic Case Report Form (eCRF). An interim analysis of this data is planned once 30% of the recruitment has been reached. Besides, the study will be overseen by an independent Data Monitoring Committee after 30% of patients´ recruitment.
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's enrollment of 296 is above the median of 200 across 34 interventional studies indexed under Aneuploidy.
Browse Aneuploidy studies →Igenomix is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
First submitted before Igenomix became part of Vitrolife.
Counted across the registry records on this site, refreshed daily.
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.
Deferred single day 6/7 blastocyst transfer with blastocyst selection according to morphology.
Other: Morphology criteria
Deferred single day 6/7 blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A).
Diagnostic Test: niPGT-A
Two scenarios should be considered according to the results in the SBM analysis: 1. The couple decides to transfer the blastocyst selected according to the SBM result (blastocyst prioritization system). 2. The couple decides to biopsy the blastocysts (if SBM results show low euploidy score). This PGT-A analysis will be offered for free but the outcome of these transfers will be excluded for the analysis per completed protocol. However, all transfers will be included in the intention-to-treat analysis. In the exceptional case of getting a non-informative result for all the SBM analysed, the niPGT-A could be performed again on new SBM samples collected after an additional culture of the embryos for, at least, 8 hours.
Embryos for transfer will be selected by the only applicable technique, the assessment of morphology according to Gardner´s criteria, which is the most standardized method.
Non-invasive analysis of the chromosomal status of the embryo
Number and structure of the embryo chromosomes
Time frame: 7 days
Ongoing pregnancy rate
Number of ongoing pregnancies per single embryo transfer
Time frame: Over 12 weeks
NGS results of the SBM
Informativity rates and prioritization category of the SBM analysis results with embryo development, culture conditions and collection time
Time frame: 7 days at least
Non-Invasive Prenatal Testing (NIPT)
Incidence of chromosomal abnormalities in NIPT within ongoing pregnancy cases
Time frame: Up to 12 weeks
Clinical miscarriage rate
Number of clinical miscarriages per total number of ongoing pregnancies
Time frame: Up to 6 months after the ovum pick-up
Analysis of the Products of Conception (POC)
Incidence of chromosomal abnormalities in POC within miscarriage cases
Time frame: Up to 20 weeks
Cumulative ongoing pregnancy rate
Cumulative ongoing pregnancy rate per patient in the 6 months after the pick-up
Time frame: Over 6 months after the ovum pick-up
Time to get an ongoing pregnancy
Time to get an ongoing pregnancy within the 6 months after the pick-up
Time frame: Up to 6 months after the ovum pick-up
Live birth rate
Number of babies born per embryo transfer
Time frame: Over 40 weeks
Cumulative live birth rate
Cumulative live birth rate per patient in the 6 months after the pick-up
Time frame: Over 6 months after the ovum pick-up
Obstetrical outcomes comparison
To compare birth weight, gestational age, APGAR, type of delivery, pregnancy complications, etc.
Time frame: Over 40 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Apr 2025, 57 months.
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This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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