mtDNA and Embryo Metabolism

NCT ID: NCT03206697

Last Updated: 2017-07-11

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

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-30

Study Completion Date

2019-02-28

Brief Summary

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The present study has the objective to study whether the mitochondrial DNA copy number values that can be generated when human embryos are analyzed for chromosomal content before embryo transfer correlates with the actual number of mitochondria as well as their energy requirements of the human embryo.

Detailed Description

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The possibility of analyzing trophectoderm cells from human blastocyst during preimplantational genetic testing offers the opportunity of analyzing not only the chromosomal constitution of the trophoblastic cells, and by extension, to infer not with certain degree of uncertainty, the chromosomal content in the inner cell cells mass and the entire embryo; but analyzing other interesting aspects related to cellular physiology such us the mtDNA content.

The number of mitochondrial copy number has a huge variation among oocytes from the same cohort and also from oocytes from different patients. It is believed that this initial number of mtDNA content is correlated with the ability of oocytes to fertilized and to achieve blastocyst stage. Whatever the initial concentration of mtDNA a given oocyte will have, it expected to equally segregate into the number of blastomeres along embryo development, so the mtDNA copy number of per daughter cell will transiently decrease, being the smallest at the blastocyst stage. Studies in different mammalian species including humans have shown that mtDNA replication does not occur before morula stage so the mitochondrial content of the oocytes should be enough to sustain embryo development before implantation occurs.

The net amount of mitochondrial DNA will exponentially increase at blastocyst stage coinciding with an increases in oxygen consumption. Despite the mtDNA copy number is higher in ICM compared to TE cells the proportion of moderate and high activity mitochondria is higher in the TE cells. This also agrees with mitochondrial morphological changes in the trophectoderm cells where mitochondria are much more elongated, less matrix electrodense and have more cristae, in ICM the will be rounded and more electrodense.

The objective of the present work is to analyze whether a correlation exist between the mitochondrial DNA copy number and both the actual number of mitochondria in the blastocyst and the metabolic needs of the human blastocysts and the ATP production.

Conditions

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Embryo Metabolic Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneuploid mitochondria

Mitochondrial DNA content and metabolic parameters

Mitochondrial DNA content and metabolic parameters

Intervention Type OTHER

Analyze the correlation between the mitochondrial DNA content and metabolic parameters.

Interventions

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Mitochondrial DNA content and metabolic parameters

Analyze the correlation between the mitochondrial DNA content and metabolic parameters.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \> 38 years old
* Sperm count: \> 2 million spermatozoids/ml
* Oocytes retrieved \> 4 oocytes MII
* Antral Follicles (AFC: ≥4)
Minimum Eligible Age

5 Days

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Igenomix

INDUSTRY

Sponsor Role collaborator

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maria Jose DeLosSantos

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Maria Jose DeLosSantos, PhD

Role: primary

+34963050900

Leslie Atkinson

Role: backup

+34963050925

Other Identifiers

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1606-VLC-047-MD

Identifier Type: -

Identifier Source: org_study_id

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