AneuploidyniPGT-A_RCTNCT04000152
RCT Study to Validate niPGT-A Clinical Benefit.
A study testing niPGT-A and Morphology criteria in people with Aneuploidy and Chromosome Abnormality, run by Igenomix at 8 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Aneuploidy, Chromosome Abnormality, Infertility
- What is being tested?
- niPGT-A and Morphology criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 29 Jun 2020to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients whose written informed consent approved by the Ethics Committee (EC) 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.
- IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication.
- All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7).
- ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed.
- Female age: 20-40 years, both included.
Who cannot join
- Assisted hatching and artificial collapse before collecting SBM samples. Note: Both procedures are allowed only after collecting the culture media sample.
- A known abnormal karyotype if the couple provides it at consultation. If not, karyotype is not compulsory.
- Couples planning to undergo PGT-M or PGT-SR cases will be excluded.
- Surrogate pregnancy (in those countries where it is allowed).
- ERA test and embryo transfer according to ERA result.
- Time-lapse culture systems are not allowed after day 4 of culture.
- Presence of pathologies or malformations that affect the uterine cavity such as polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx during the patient's participation in the study. Patients suffering these pathologies before or after their inclusion in the study can participate if the pathology is corrected before performing any study procedure.
- Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Argentina2 sites
Crecer: Centro de Reproducción y Genética Humana
Mar del Plata, Buenos Aires
Saresa - Reproducción Humana Asistida
Salta, Salta Province, 4400
Brazil2 sites
Nilo Frantz - Centro de Reprodução Humana
Boa Vista, Porto Alegre, 91330-002
Vida - Centro de Fertilidade
Rio de Janeiro, Rio de Janeiro, 22793-080
Italy2 sites
Società Italiana Studi di Medicina della Riproduzione (S.I.S.M.e.R.)
Bologna, Bologna, 40138
Centro Procreazione Assistita DEMETRA
Florence, Firenze, 50141
About this study
Official title: Randomized Controlled Clinical Study to Assess the Benefit of Non-invasive PGT-A, by the Analysis of Spent Blastocyst Media, as a Tool for Embryo Prioritization in Infertile Patients Undergoing Assisted Reproduction.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Aneuploidy, Chromosome Abnormality, Infertility
- Being tested
- niPGT-A, Morphology criteria
- Keywords
- Blastocyst, Non-invasive, PGT-A, Aneuploidy, Spent culture medium, Trophectoderm biopsy, Sustained implantation, Miscarriage, Livebirth
- Medical subject headings
- Aneuploidy, Chromosome Aberrations, Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niPGT-ADiagnostic test
Two scenarios should be considered according to the results in the SBM analysis:
- The couple decides to transfer the blastocyst selected according to the SBM result (blastocyst prioritization system).
- 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.
Morphology criteriaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (group 1) | Active comparator | Deferred single day 6/7 blastocyst transfer with blastocyst selection according to morphology. Receives: Other: Morphology criteria |
| Intervention group (group 2) | Experimental | Deferred single day 6/7 blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A). Receives: Diagnostic Test: niPGT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive analysis of the chromosomal status of the embryo
Number and structure of the embryo chromosomes
Measured: 7 days
Ongoing pregnancy rate
Number of ongoing pregnancies per single embryo transfer
Measured: Over 12 weeks
Secondary outcomes (9)
NGS results of the SBM
Informativity rates and prioritization category of the SBM analysis results with embryo development, culture conditions and collection time
Measured: 7 days at least
Non-Invasive Prenatal Testing (NIPT)
Incidence of chromosomal abnormalities in NIPT within ongoing pregnancy cases
Measured: Up to 12 weeks
Clinical miscarriage rate
Number of clinical miscarriages per total number of ongoing pregnancies
Measured: 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
Measured: Up to 20 weeks
Cumulative ongoing pregnancy rate
Cumulative ongoing pregnancy rate per patient in the 6 months after the pick-up
Measured: 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
Measured: Up to 6 months after the ovum pick-up
Live birth rate
Number of babies born per embryo transfer
Measured: Over 40 weeks
Cumulative live birth rate
Cumulative live birth rate per patient in the 6 months after the pick-up
Measured: Over 6 months after the ovum pick-up
Obstetrical outcomes comparison
To compare birth weight, gestational age, APGAR, type of delivery, pregnancy complications, etc.
Measured: Over 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start29 Jun 2020
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Why it stopped: The recruitment was halted on Mar 1st 2024, after the Data Monitoring Committee, due to low recruitment speed and sustained high dropout rate. Other elements impacted negatively, including the SARS-COV-2 pandemic or the inability to include new sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneuploidyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carmen Rubio, PhD, Principal investigator, Igenomix S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000152
- Sponsor's protocol ID
- IGX1-NIP-CS-18-05
- Acronym
- niPGT-A_RCT
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2019
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study to Assess the Benefit of Non-invasive PGT-A, by the Analysis of Spent Blastocyst Media, as a Tool for Embryo Prioritization in Infertile Patients Undergoing Assisted Reproduction.
- ClinicalTrials.gov ID
- NCT04000152
- Acronym / sponsor ID
- niPGT-A_RCT / IGX1-NIP-CS-18-05
- Conditions
- Aneuploidy, Chromosome Abnormality, Infertility
- Keywords
- Blastocyst, Non-invasive, PGT-A, Aneuploidy, Spent culture medium, Trophectoderm biopsy, Sustained implantation, Miscarriage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment was halted on Mar 1st 2024, after the Data Monitoring Committee, due to low recruitment speed and sustained high dropout rate. Other elements impacted negatively, including the SARS-COV-2 pandemic or the inability to include new sites
- Enrolment
- 296 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (group 1) | Active comparator | Other: Morphology criteriaDeferred single day 6/7 blastocyst transfer with blastocyst selection according to morphology. |
| Intervention group (group 2) | Experimental | Diagnostic Test: niPGT-ADeferred single day 6/7 blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients whose written informed consent approved by the Ethics Committee (EC) 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.
- IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication.
- All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7).
- ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed.
- Female age: 20-40 years, both included.
Key exclusion criteria (8 listed)
- Assisted hatching and artificial collapse before collecting SBM samples. Note: Both procedures are allowed only after collecting the culture media sample.
- A known abnormal karyotype if the couple provides it at consultation. If not, karyotype is not compulsory.
- Couples planning to undergo PGT-M or PGT-SR cases will be excluded.
- Surrogate pregnancy (in those countries where it is allowed).
- ERA test and embryo transfer according to ERA result.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niPGT-ATwo 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. | Diagnostic test | Intervention group (group 2) |
| Morphology criteriaEmbryos 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. | Other | Control group (group 1) |
Primary outcome
Non-invasive analysis of the chromosomal status of the embryo
Time frame: 7 days
Number and structure of the embryo chromosomes
Ongoing pregnancy rate
Time frame: Over 12 weeks
Number of ongoing pregnancies per single embryo transfer
9 secondary outcomes
NGS results of the SBM
Time frame: 7 days at least
Non-Invasive Prenatal Testing (NIPT)
Time frame: Up to 12 weeks
Clinical miscarriage rate
Time frame: Up to 6 months after the ovum pick-up
Analysis of the Products of Conception (POC)
Time frame: Up to 20 weeks
Cumulative ongoing pregnancy rate
Time frame: Over 6 months after the ovum pick-up
Time to get an ongoing pregnancy
Time frame: Up to 6 months after the ovum pick-up
Live birth rate
Time frame: Over 40 weeks
Cumulative live birth rate
Time frame: Over 6 months after the ovum pick-up
Obstetrical outcomes comparison
Time frame: Over 40 weeks
Results and safety
The study was stopped early (reason given: The recruitment was halted on Mar 1st 2024, after the Data Monitoring Committee, due to low recruitment speed and sustained high dropout rate. Other elements impacted negatively, including the SARS-COV-2 pandemic or the inability to include new sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Rubio, PhD principal investigator
Igenomix S.L.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing niPGT-A and Morphology criteria in people with Aneuploidy and Chromosome Abnormality, run by Igenomix at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, Brazil, Italy, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The recruitment was halted on Mar 1st 2024, after the Data Monitoring Committee, due to low recruitment speed and sustained high dropout rate. Other elements impacted negatively, including the SARS-COV-2 pandemic or the inability to include new sites). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive analysis of the chromosomal status of the embryo (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.