InfertilityMitoScoreNCT02662686
Study for the Evaluation of "MitoScore" Marker in the Diagnosis of Embryo Viability in Euploids Embryos
A study testing Transfer according to morphological criteria and Transfer according to the MitoScore results in people with Infertility, run by Igenomix at 11 sites in Spain.
Trial summary
The number of copies of mitochondrial genes (mtDNA or "MitoScore") is related to the energy supply of the embryo, which can affect its ability to implant in the maternal uterus. The objective of this study is to analyse the potential of MitoScore before embryo transfer as a marker to identify and select the embryo… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Transfer according to morphological criteria and Transfer according to the MitoScore results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,718 participants
- Where
- 11 sitesSpain
- Study dates
- Jan 2016to Dec 2019
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PGS cycles for different indications
- Maternal age: ≤40 years old (FIV/ICSI patients)
- Maternal age: <50 years old (OVODON patients)
- Spermatocyte concentration: > 2 million of spermatocyte/ml
- Single embryo transfer
- -≥ 8 oocytes MII
- Number of Antral Follicules (AFC: ≥10 MII)
Who cannot join
- Detection in the moment of inclusion or previous diagnosis of congenital uterine malformations.
- Patients with embryo sex selection for those countries in which it is allowed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
IVI Alicante
Alicante, 03015
IVI Madrid
Aravaca, Madrid, 28023
IVI Barcelona
Barcelona, 08017
IVI Las Palmas
Las Palmas de Gran Canaria, Las Palmas, 35019
IVI Bilbao
Leioa, Vizcaya, 48940
IVI Malaga
Málaga, 29016
IVI Murcia
Murcia, 30007
IVI Vigo
Pontevedra, 35203
IVI Sevilla
Seville, 41011
IVI Valencia
Valencia, 46015
IVI Zaragoza
Zaragoza, 50018
About this study
Official title: Randomized Multi-centric Prospective Study for the Evaluation of "MitoScore" Marker in the Diagnosis of Embryo Viability in Euploids Embryos.
The number of copies of mitochondrial genes (mtDNA or "MitoScore") is related to the energy supply of the embryo, which can affect its ability to implant in the maternal uterus.
The objective of this study is to analyse the potential of MitoScore before embryo transfer as a marker to identify and select the embryo with greater capacity of implantation. First of all, chromosomally normal embryos will be selected and mtDNA copies will be quantified. Finally, embryos with less copies of mtDNA will be considered for embryo transfer.
Read the detailed description
The number of mitochondrial DNA copies (mtDNA) of a chromosomally normal embryo is related to a state of energy, which affects the ability of the embryo to implant in the maternal uterus. There is a decrease in the rate of implantation in euploid embryos containing a high number of mtDNA copies. It is known that after a certain number of mtDNA copies implantation is disrupted even in euploid embryos.
The main purpose of this study is to evaluate the possible relationship between the mtDNA content contained in developing embryos and the result of implantation in order to evaluate the potential of such relationship as a diagnostic tool.
The number of mtDNA copies present in chromosomally normal embryos will be quantified. Subsequently, the transfer of euploid embryos after the randomization will be using either routine morphological or MitoScore criteria.
Study population: women undergoing either IVF or egg donation that go through preimplantation genetic screening (PGS) for different indications, either in day 5/6 or day 3.
This is a triple blinded, randomized, prospective, clinical study where patients with embryos analyzed by PGS in blastocyst stage or day 3 and mitochondrial analysis with day 5/6 transfer, with deferred cycle for those analyzed in day 5/6 and fresh embryo transfer for those analyzed in day 3, will be randomized into two groups:
GROUP A: Embryo selection for transfer will be based initially on chromosomal normality and secondly on embryo morphology criteria (specific for IVF lab).
GROUP B: Embryo selection for transfer will be based initially on chromosomal normality and secondly on the MitoScore value, trying to transfer normal embryos containing the lowest number of mitochondrial DNA copies.
- Conditions
- Infertility
- Being tested
- Transfer according to morphological criteria, Transfer according to the MitoScore results
- Keywords
- Embryo Implantation, Mitochondrial genes, Mitochondrial DNA, MitoScore, Embryo selection, Embryo viability, Embryo biomarker, Diagnosis of embryo viability in euploids embryos
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer according to morphological criteriaOther
Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to morphological criteria (control group).
Transfer according to the MitoScore resultsOther
Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to the MitoScore results (experimental group).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Embryo selection for transfer will be based initially on chromosomally normal embryos and secondly on embryo morphology criteria (specific of IVF lab, as standard practice). Receives: Other: Transfer according to morphological criteria |
| MitoScore | Experimental | Embryo selection for transfer will be based initially on chromosomal normality and secondly on the MitoScore value, trying to transfer chromosomally normal embryos which contain the lowest number of mitochondrial DNA copies. Receives: Other: Transfer according to the MitoScore results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Measured: 20 days
Pregnancy rate
Measured: 12 days
Secondary outcomes (2)
Miscarriage rate
Measured: 9 months
Ongoing pregnancy rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,718 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Antonio Diez, Igenomix
- Investigators
- Antonio Diez, BS PhD, Principal investigator, IgenomixCarlos Simon, MD PhD, Study director, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662686
- Sponsor's protocol ID
- 1506-IGX-042-AD
- Acronym
- MitoScore
- Status last verified
- Aug 2018
- First submitted
- 14 Jan 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi-centric Prospective Study for the Evaluation of "MitoScore" Marker in the Diagnosis of Embryo Viability in Euploids Embryos.
- ClinicalTrials.gov ID
- NCT02662686
- Acronym / sponsor ID
- MitoScore / 1506-IGX-042-AD
- Conditions
- Infertility
- Keywords
- Embryo Implantation, Mitochondrial genes, Mitochondrial DNA, MitoScore, Embryo selection, Embryo viability, Embryo biomarker, Diagnosis of embryo viability in euploids embryos
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,718 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- 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 number of copies of mitochondrial genes (mtDNA or "MitoScore") is related to the energy supply of the embryo, which can affect its ability to implant in the maternal uterus.
The objective of this study is to analyse the potential of MitoScore before embryo transfer as a marker to identify and select the embryo with greater capacity of implantation. First of all, chromosomally normal embryos will be selected and mtDNA copies will be quantified. Finally, embryos with less copies of mtDNA will be considered for embryo transfer.
Detailed description
The number of mitochondrial DNA copies (mtDNA) of a chromosomally normal embryo is related to a state of energy, which affects the ability of the embryo to implant in the maternal uterus. There is a decrease in the rate of implantation in euploid embryos containing a high number of mtDNA copies. It is known that after a certain number of mtDNA copies implantation is disrupted even in euploid embryos.
The main purpose of this study is to evaluate the possible relationship between the mtDNA content contained in developing embryos and the result of implantation in order to evaluate the potential of such relationship as a diagnostic tool.
The number of mtDNA copies present in chromosomally normal embryos will be quantified. Subsequently, the transfer of euploid embryos after the randomization will be using either routine morphological or MitoScore criteria.
Study population: women undergoing either IVF or egg donation that go through preimplantation genetic screening (PGS) for different indications, either in day 5/6 or day 3.
This is a triple blinded, randomized, prospective, clinical study where patients with embryos analyzed by PGS in blastocyst stage or day 3 and mitochondrial analysis with day 5/6 transfer, with deferred cycle for those analyzed in day 5/6 and fresh embryo transfer for those analyzed in day 3, will be randomized into two groups:
GROUP A: Embryo selection for transfer will be based initially on chromosomal normality and secondly on embryo morphology criteria (specific for IVF lab).
GROUP B: Embryo selection for transfer will be based initially on chromosomal normality and secondly on the MitoScore value, trying to transfer normal embryos containing the lowest number of mitochondrial DNA copies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Transfer according to morphological criteriaEmbryo selection for transfer will be based initially on chromosomally normal embryos and secondly on embryo morphology criteria (specific of IVF lab, as standard practice). |
| MitoScore | Experimental | Other: Transfer according to the MitoScore resultsEmbryo selection for transfer will be based initially on chromosomal normality and secondly on the MitoScore value, trying to transfer chromosomally normal embryos which contain the lowest number of mitochondrial DNA copies. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- -≥ 8 oocytes MII
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Transfer according to morphological criteriaEmbryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to morphological criteria (control group). | Other | Control |
| Transfer according to the MitoScore resultsEmbryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to the MitoScore results (experimental group). | Other | MitoScore |
Primary outcome
Implantation rate
Time frame: 20 days
Pregnancy rate
Time frame: 12 days
2 secondary outcomes
Miscarriage rate
Time frame: 9 months
Ongoing pregnancy rate
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Antonio Diez, BS PhD principal investigator
Igenomix
Carlos Simon, MD PhD study director
Igenomix
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer according to morphological criteria and Transfer according to the MitoScore results in people with Infertility, run by Igenomix at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: 20 days). The study lists 2 primary outcomes in all. 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 8 Aug 2018.