Embryo Metabolic ActivityNCT03206697
mtDNA and Embryo Metabolism
An observational study of Embryo Metabolic Activity, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Embryo Metabolic Activity
- What is being tested?
- Mitochondrial DNA content and metabolic parameters
- How many people
- 171 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2017to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Blastocysts from women undergoing PGT-A and available for analysis )
Inclusion Criteria of women whose blastocysts will undergo PGT-A and be eligible for study:
- > 38 years old
- Sperm count: > 2 million spermatozoids/ml
- Oocytes retrieved > 4 oocytes MII
- Antral Follicles (AFC: ≥4)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Maria Jose DeLosSantos
Valencia, 46015
Maria Jose DeLosSantos, PhD, +34963050900, mjdelossantos@ivi.es
Leslie Atkinson, +34963050925, leslie.atkinson@ivi.es
About this study
Official title: Definition: Evaluation of Mitichondrial Values and it Relationship With Embryo Metabolism and Mitochondrial Homeostasis.
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.
Read the detailed description
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
- Embryo Metabolic Activity
- Being tested
- Mitochondrial DNA content and metabolic parameters
- Keywords
- mitochondrial copy, number and energy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitochondrial DNA content and metabolic parametersOther
Analyze the correlation between the mitochondrial DNA content and metabolic parameters.
| Study group | Role | What they receive |
|---|---|---|
| Aneuploid mitochondria | Mitochondrial DNA content and metabolic parameters Receives: Other: Mitochondrial DNA content and metabolic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between mitochondrial DNA content and number of mitochondria and Correlation between mitochondrial DNA content and metabolic turnover
Correlation index between each variable
Measured: Each embryo will need an average of one week for assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start30 Jun 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo Metabolic ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- Igenomix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206697
- Sponsor's protocol ID
- 1606-VLC-047-MD
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition: Evaluation of Mitichondrial Values and it Relationship With Embryo Metabolism and Mitochondrial Homeostasis.
- ClinicalTrials.gov ID
- NCT03206697
- Acronym / sponsor ID
- 1606-VLC-047-MD
- Conditions
- Embryo Metabolic Activity
- Keywords
- mitochondrial copy, number and energy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- Igenomix
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneuploid mitochondria | – | Other: Mitochondrial DNA content and metabolic parametersMitochondrial DNA content and metabolic parameters |
Who may qualify
- Ages
- 5 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Blastocysts from women undergoing PGT-A and available for analysis )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitochondrial DNA content and metabolic parametersAnalyze the correlation between the mitochondrial DNA content and metabolic parameters. | Other | Aneuploid mitochondria |
Primary outcome
Correlation between mitochondrial DNA content and number of mitochondria and Correlation between mitochondrial DNA content and metabolic turnover
Time frame: Each embryo will need an average of one week for assessment
Correlation index between each variable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Metabolic Activity, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between mitochondrial DNA content and number of mitochondria and Correlation between mitochondrial DNA content and metabolic turnover (time frame: Each embryo will need an average of one week for assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.