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NCT Number: NCT05488236

Nuclear Magnetic Resonance for Embryo Ploidy Selection

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.

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Valenciano de Infertilidade

Lisbon, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nuclear magnetic resonance analysis of embryo culture medium

Other

Analysis of culture medium from euploid and aneuploid embryos by magnetic nuclear resonance.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidade de Lisboa

Network

Collaborators

  • Universidade Nova de Lisboa

Registry information

Official study title

Embryo Ploidy Selection by Nuclear Magnetic Resonance: a Fast, Low Cost and Non-invasive Technique to Increase the Success Rate of ART

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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