Nuclear Magnetic Resonance for Embryo Ploidy Selection

NCT05488236 | Completed

• 1 other identifier: 2004-LIS-037-SN
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneuploidy; Infertility

Keywords

Non-invasive embryo selection; Metabolic profile; Nuclear magnetic resonance

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Nuclear magnetic resonance analysis of embryo culture medium OTHER

Analysis of culture medium from euploid and aneuploid embryos by magnetic nuclear resonance.

Eligibility Criteria

• Age: 18 Years - 48 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidade de Lisboa: lead
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Instituto Valenciano de Infertilidade

Lisbon, Portugal

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples: culture medium from euploid and aneuploid embryos.

MeSH Terms

Conditions

Aneuploidy; Infertility

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Study Officials

• Sofia Nunes, PhD

  Instituto Valenciano de Infertilidade de Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: August 4, 2022
• Study Start: April 7, 2021
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: April 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)