AneuploidyNCT05488236
Nuclear Magnetic Resonance for Embryo Ploidy Selection
An observational study of Aneuploidy and Infertility, run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
Trial summary
This study aims to validate the embryo culture medium analysis by nuclear magnetic resonance spectroscopy, as a faster and less-costly alternative to preimplantation genetic test for aneuploidy which could significantly enhance embryo selection and the success rate of assisted reproductive technologies. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy, Infertility
- What is being tested?
- Nuclear magnetic resonance analysis of embryo culture medium
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Apr 2021to 7 Jun 2023
- Phase
- Observational
- 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 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women who will undergo a In vitro fertilization followed by preimplantation genetic test for aneuploidy.
Who may be able to join
- Age: ≥18 and <49 years old.
- Body Mass Index ≥18.5 Kg/m2 and <30 Kg/m2.
- Planned for in vitro fertilization followed by preimplantation genetic test for aneuploidy.
- Oocytes retrieval and fertilization by intracytoplasmic sperm injection
- Six follicles over 14 mm on the day of the triggering. Gonadotropin-releasing hormone antagonist
- Signed and dated informed consent.
Who cannot join
- Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose of ovarian stimulation (≥300 IU/day).
- Presence of a medical condition which is known to affect assisted reproductive technologies outcome (e.g. thyroid dysfunction).
- Active female smoking.
- Current use of anti-depressants, anti-psychotics, steroids, antiepileptics or chemotherapy.
- Those unable to comprehend the investigational nature of the proposed study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Embryo Ploidy Selection by Nuclear Magnetic Resonance: a Fast, Low Cost and Non-invasive Technique to Increase the Success Rate of ART
This study aims to validate the embryo culture medium analysis by nuclear magnetic resonance spectroscopy, as a faster and less-costly alternative to preimplantation genetic test for aneuploidy which could significantly enhance embryo selection and the success rate of assisted reproductive technologies.
Read the detailed description
Assisted reproductive technologies (ART) refers to treatments used to assist people in achieving a pregnancy. Over the last years, ART have been developed with efforts to deliver a healthy baby. However, the selection of the embryo that most likely results in pregnancy remains a critical step in ART. Currently, this selection is based on morphological assessment of the embryos, but up to 70% of those embryos display an abnormal number of chromosomes. Preimplantation genetic test for aneuploidy (PGT-A) is used to assess the ploidy of embryos, although this is an invasive, expensive and time consuming technique. Alternatively, in order to predict the ploidy of pre-implantation embryos (euploidy vs aneuploidy), we suggest to characterise the metabolic profile of the embryo culture medium by Nuclear Magnetic Resonance (NMR), which is a non-invasive, low cost and fast technique.
The aim of this study is to assess whether, using multivariable analysis to all the collected NMR data, it is possible to identify a differential metabolic pattern between aneuploid and euploid embryos which could improve embryo selection.
- Conditions
- Aneuploidy, Infertility
- Being tested
- Nuclear magnetic resonance analysis of embryo culture medium
- Keywords
- Non-invasive embryo selection, Metabolic profile, Nuclear magnetic resonance
- Medical subject headings
- Aneuploidy, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuclear magnetic resonance analysis of embryo culture mediumOther
Analysis of culture medium from euploid and aneuploid embryos by magnetic nuclear resonance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos.
The metabolites present in the culture medium of euploid and aneuploid embryos will be identified by NMR and compared to the metabolites present in the culture medium without embryo (control). The metabolic profiles of cultures form euploid and aneuploid embryos will be compared to the metabolic profile of culture medium without embryo.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start7 Apr 2021
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidade de Lisboa
- Sponsor type
- Research network
- Collaborators
- Universidade Nova de Lisboa
- Responsible party
- Sponsor
- Investigators
- Sofia Nunes, PhD, Principal investigator, Instituto Valenciano de Infertilidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488236
- Sponsor's protocol ID
- 2004-LIS-037-SN
- Status last verified
- May 2025
- First submitted
- 19 Apr 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Ploidy Selection by Nuclear Magnetic Resonance: a Fast, Low Cost and Non-invasive Technique to Increase the Success Rate of ART
- ClinicalTrials.gov ID
- NCT05488236
- Acronym / sponsor ID
- 2004-LIS-037-SN
- Conditions
- Aneuploidy, Infertility
- Keywords
- Non-invasive embryo selection, Metabolic profile, Nuclear magnetic resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidade de LisboaResearch network
- Collaborators
- Universidade Nova de Lisboa
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 4 Aug 2022 (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.
This study aims to validate the embryo culture medium analysis by nuclear magnetic resonance spectroscopy, as a faster and less-costly alternative to preimplantation genetic test for aneuploidy which could significantly enhance embryo selection and the success rate of assisted reproductive technologies.
Detailed description
Assisted reproductive technologies (ART) refers to treatments used to assist people in achieving a pregnancy. Over the last years, ART have been developed with efforts to deliver a healthy baby. However, the selection of the embryo that most likely results in pregnancy remains a critical step in ART. Currently, this selection is based on morphological assessment of the embryos, but up to 70% of those embryos display an abnormal number of chromosomes. Preimplantation genetic test for aneuploidy (PGT-A) is used to assess the ploidy of embryos, although this is an invasive, expensive and time consuming technique. Alternatively, in order to predict the ploidy of pre-implantation embryos (euploidy vs aneuploidy), we suggest to characterise the metabolic profile of the embryo culture medium by Nuclear Magnetic Resonance (NMR), which is a non-invasive, low cost and fast technique.
The aim of this study is to assess whether, using multivariable analysis to all the collected NMR data, it is possible to identify a differential metabolic pattern between aneuploid and euploid embryos which could improve embryo selection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women who will undergo a In vitro fertilization followed by preimplantation genetic test for aneuploidy.
Key inclusion criteria (6 listed)
- Age: ≥18 and <49 years old.
- Body Mass Index ≥18.5 Kg/m2 and <30 Kg/m2.
- Planned for in vitro fertilization followed by preimplantation genetic test for aneuploidy.
- Oocytes retrieval and fertilization by intracytoplasmic sperm injection
- Six follicles over 14 mm on the day of the triggering. Gonadotropin-releasing hormone antagonist
Key exclusion criteria (5 listed)
- Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose of ovarian stimulation (≥300 IU/day).
- Presence of a medical condition which is known to affect assisted reproductive technologies outcome (e.g. thyroid dysfunction).
- Active female smoking.
- Current use of anti-depressants, anti-psychotics, steroids, antiepileptics or chemotherapy.
- Those unable to comprehend the investigational nature of the proposed study.
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 |
|---|---|---|
| Nuclear magnetic resonance analysis of embryo culture mediumAnalysis of culture medium from euploid and aneuploid embryos by magnetic nuclear resonance. | Other | – |
Primary outcome
Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos.
Time frame: 6 months
The metabolites present in the culture medium of euploid and aneuploid embryos will be identified by NMR and compared to the metabolites present in the culture medium without embryo (control). The metabolic profiles of cultures form euploid and aneuploid embryos will be compared to the metabolic profile of culture medium without embryo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
Sofia Nunes, PhD principal investigator
Instituto Valenciano de Infertilidade de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneuploidy and Infertility, run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos. (time frame: 6 months). 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 13 Apr 2026.