Clinical trial NCT05488236: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneuploidy
Infertility
Keywords: Non-invasive embryo selection
Metabolic profile
Nuclear magnetic resonance
Lead sponsor: Instituto Valenciano de Infertilidade de Lisboa
Sponsor class: NETWORK
Collaborators: name: Universidade Nova de Lisboa
First posted: 2022-08-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women who will undergo a In vitro fertilization followed by preimplantation genetic test for aneuploidy.

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.

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.

Primary outcomes:
measure: Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Instituto Valenciano de Infertilidade
Study officials:
affiliation: Instituto Valenciano de Infertilidade de Lisboa
name: Sofia Nunes, PhD
role: PRINCIPAL_INVESTIGATOR
References: