Nuclear Magnetic Resonance for Embryo Ploidy Selection

• Conditions: Infertility; Aneuploidy

• Registration Number: NCT05488236
• Lead Sponsor: Instituto Valenciano de Infertilidade de Lisboa

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.

Study Timeline

• Study Start: 2021-04-07
• Study First Submitted: 2021-04-19
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-10-07
• Study Completion: 2023-12-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos.	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.

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidade; 🇵🇹 Lisbon, Portugal