Nuclear Magnetic Resonance for Embryo Ploidy Selection

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Aneuploidy
• Intervention / Treatment: Other: Nuclear magnetic resonance analysis of embryo culture medium

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Sofia Nunes, PhD; Phone Number: +351 218 50 32 10; Email: sofia.nunes@ivirma.com
• Study Contact Backup: Name: Samuel Santos-Ribeiro, MD, PhD; Phone Number: +351 218 50 32 10; Email: samuel.ribeiro@ivirma.com

Study Locations

• Portugal
  • Lisbon, Portugal
    • Recruiting
    • Instituto Valenciano de Infertilidade
    • Contact: Samuel Santos-Ribeiro, MD, PhD; Phone Number: +351 218 50 32 10; Email: samuel.ribeiro@ivirma.com
    • Contact: Carla Jorge, PhD; Phone Number: +351 218 50 32 10; Email: carla.jorge@ivirma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidade de Lisboa
• Collaborators: Universidade Nova de Lisboa
• Investigators: Principal Investigator: Sofia Nunes, PhD, Instituto Valenciano de Infertilidade de Lisboa

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 7, 2021
• Primary Completion (ANTICIPATED): October 7, 2023
• Study Completion (ANTICIPATED): December 6, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (ACTUAL): August 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Metabolic profile; Nuclear magnetic resonance; Non-invasive embryo selection
• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Infertility; Aneuploidy
• Other Study ID Numbers: 2004-LIS-037-SN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No