Nuclear Magnetic Resonance for Embryo Ploidy Selection | NCT05488236

Studies
Nuclear Magnetic Resonance for Embryo Ploidy Selection

NCT05488236

Sponsor

Instituto Valenciano de Infertilidade de Lisboa

Status

Completed

Last Update Posted

Apr 13, 2026Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Aneuploidy
Infertility

Interventions

Nuclear magnetic resonance analysis of embryo culture medium

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2021Actual

Primary Completion Date

Jun 7, 2023Actual

Completion Date

Jun 7, 2023Actual

First Submitted Date

Apr 19, 2021

First Submission Date that Met QC Criteria

Aug 2, 2022

First Posted Date

Aug 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 13, 2026Actual

Name	Class
Universidade Nova de Lisboa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nuclear magnetic resonance analysis of embryo culture medium	Other	Analysis of culture medium from euploid and aneuploid embryos by magnetic nuclear resonance.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Healthy women who will undergo a In vitro fertilization followed by preimplantation genetic test for aneuploidy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sofia Nunes, PhD	Instituto Valenciano de Infertilidade de Lisboa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Valenciano de Infertilidade		Lisbon			Portugal

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 20, 2021	May 29, 2025	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000782	Aneuploidy
D007246	Infertility

Ancestor Terms

ID	Term
D002869	Chromosome Aberrations
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided