Nuclear Magnetic Resonance for Embryo Ploidy Selection

NCT ID: NCT05488236

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-07

Study Completion Date

2023-12-06

Brief Summary

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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

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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.

Conditions

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Aneuploidy Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Nuclear magnetic resonance analysis of embryo culture medium

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Nova de Lisboa

OTHER

Sponsor Role collaborator

Instituto Valenciano de Infertilidade de Lisboa

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofia Nunes, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Valenciano de Infertilidade de Lisboa

Locations

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Instituto Valenciano de Infertilidade

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Sofia Nunes, PhD

Role: CONTACT

+351 218 50 32 10

Samuel Santos-Ribeiro, MD, PhD

Role: CONTACT

+351 218 50 32 10

Facility Contacts

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Carla Jorge, PhD

Role: primary

+351 218 50 32 10

Samuel Santos-Ribeiro, MD, PhD

Role: backup

+351 218 50 32 10

Other Identifiers

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2004-LIS-037-SN

Identifier Type: -

Identifier Source: org_study_id

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