Nuclear Magnetic Resonance for Embryo Ploidy Selection

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488236
• Other study ID #: 2004-LIS-037-SN
• Status: Recruiting
• Start date: April 7, 2021
• Est. completion date: December 6, 2023

Study information

• Verified date: August 2022
• Source: Instituto Valenciano de Infertilidade de Lisboa
• Contact: Sofia Nunes, PhD
• Phone: +351 218 50 32 10
• Email: sofia.nunes[@]ivirma.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 6, 2023
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneuploidy
• Infertility

Intervention

Other:
• Nuclear magnetic resonance analysis of embryo culture medium
Analysis of culture medium from euploid and aneuploid embryos by magnetic nuclear resonance.

Locations

Country	Name	City	State
Portugal	Instituto Valenciano de Infertilidade	Lisbon

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidade de Lisboa	Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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