InfertilityNCT04976920
Metabolomics Non Selection Study - Vitrolife Media
An observational study of Infertility, run by Overture Life at 2 sites in 2 countries.
Trial summary
In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Overture Metabolomics Embryo Selection
- Type of treatment
- Injection or infusion
- How many people
- 205 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jul 2021to 30 Jan 2024
- 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients recruited from an IVF center
Who may be able to join
- Women of any age, 25% of patients <35 years, 25% of patients 35-37, 25% of patients 38-40, and 25% of patients >40 years.
- Signed Subject Consent Form. No inferior limit on number of eggs
Who cannot join
- At the time of initial visit:
- Require or request PGT of any kind
- Low ovarian reserve defined as follicle stimulating hormone (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) <15 pmol/L (or <2 ng/ml) within prior 12 months of cycle start
- At the time of embryo selection:
- -Patients without at least one embryo to transfer.
Trial locations and contacts
2 sites in 2 countries.
Sara Cabello contact
2 sites in 2 countries
Argentina1 site, 1 recruiting
- Recruiting
Grupo Procrearte
Buenos Aires
Ariel Ahumada, MD
Ariel Ahumada, MD
Spain1 site, 1 recruiting
- Recruiting
Clinical Juana Crespo
Valencia
Jose Teruel Lopez
Juana Crespo, MD
About this study
Official title: Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media
In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo.
Read the detailed description
Patients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.
Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis.
For the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist.
Approximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. Should the test be negative, they will be closed out of the study. Should the test be positive, they will continue to be monitored.
The patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. The outcome will be documented and the patient closed out of the study at this time.
The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.
- Conditions
- Infertility
- Being tested
- Overture Metabolomics Embryo Selection
- Keywords
- IVF, genetic screening, preimplantation genetic testing
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overture Metabolomics Embryo SelectionDiagnostic test
Patients will have their embryos selected for transfer based on morphology alone. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Patients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.
Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis.
For the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation. Receives: Diagnostic Test: Overture Metabolomics Embryo Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.
PPV (MEI high potential implanting / Total implanting), NPV (MEI low potential implanting / Total not implanting)
Measured: Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start12 Jul 2021
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overture Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinica Juana Crespo, Grupo Procrearte
- Responsible party
- Principal investigator, Dr. Jose Horcajadas, Overture Life
- Investigators
- Jose Horcajadas, PhD, Principal investigator, Overture LifeSantiago Munne, PhD, Principal investigator, Overture Life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976920
- Sponsor's protocol ID
- OLM001
- Status last verified
- Nov 2023
- First submitted
- 15 Jul 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be presented at industry conferences, and published in peer reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media
- ClinicalTrials.gov ID
- NCT04976920
- Acronym / sponsor ID
- OLM001
- Conditions
- Infertility
- Keywords
- IVF, genetic screening, preimplantation genetic testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Overture LifeIndustry (pharma, biotech, devices)
- Collaborators
- Clinica Juana Crespo, Grupo Procrearte
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 26 Jul 2021 (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.
In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo.
Detailed description
Patients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.
Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis.
For the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist.
Approximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. Should the test be negative, they will be closed out of the study. Should the test be positive, they will continue to be monitored.
The patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. The outcome will be documented and the patient closed out of the study at this time.
The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Diagnostic Test: Overture Metabolomics Embryo SelectionPatients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days. Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis. For the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients recruited from an IVF center
Key inclusion criteria (2 listed)
- Women of any age, 25% of patients <35 years, 25% of patients 35-37, 25% of patients 38-40, and 25% of patients >40 years.
- Signed Subject Consent Form. No inferior limit on number of eggs
Key exclusion criteria (5 listed)
- Require or request PGT of any kind
- Low ovarian reserve defined as follicle stimulating hormone (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) <15 pmol/L (or <2 ng/ml) within prior 12 months of cycle start
- -Patients without at least one embryo to transfer.
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 |
|---|---|---|
| Overture Metabolomics Embryo SelectionPatients will have their embryos selected for transfer based on morphology alone. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation. | Diagnostic test | Treatment Group |
Primary outcome
Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.
Time frame: Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks
PPV (MEI high potential implanting / Total implanting), NPV (MEI low potential implanting / Total not implanting)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No. Data will be presented at industry conferences, and published in peer reviewed journals.
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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.
Sara Cabello contact
Jose Horcajadas, PhD principal investigator
Overture Life
Santiago Munne, PhD principal investigator
Overture Life
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Overture Life at 2 sites in 2 countries.
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 2 inclusion and 5 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, 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?
Contact Alexander Nadal (323-420-6343, alex@overture.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology. (time frame: Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks). 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 14 Nov 2023.