Nuclear Magnetic Resonance for Embryo Ploidy Selection

Brief Title

Nuclear Magnetic Resonance for Embryo Ploidy Selection

Official Title

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

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 Type

Observational


Primary Outcome

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


Condition

Aneuploidy

Intervention

Nuclear magnetic resonance analysis of embryo culture medium


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

April 7, 2021

Completion Date

December 6, 2023

Primary Completion Date

October 7, 2023

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.
      

Gender

Female

Ages

18 Years - 48 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sofia Nunes, PhD, +351 218 50 32 10, [email protected]

Location Countries

Portugal

Location Countries

Portugal

Administrative Informations


NCT ID

NCT05488236

Organization ID

2004-LIS-037-SN


Responsible Party

Sponsor

Study Sponsor

Instituto Valenciano de Infertilidade de Lisboa

Collaborators

 Universidade Nova de Lisboa

Study Sponsor

Sofia Nunes, PhD, Principal Investigator, Instituto Valenciano de Infertilidade de Lisboa


Verification Date

August 2022