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