Embryo SelectionNCT02698488
Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology
A study testing Morphology and Morphology and Mass Spectroscopy in people with Embryo Selection and IVF, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Identification of the embryo with the highest potential to implant and establish an ongoing pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day by embryologists worldwide during the treatment of couples that wish to conceive by IVF. Read more about this study
- Who is it for?
- Ages 21 to 38 years, women only
- Conditions the study is for
- Embryo Selection, IVF, Morphology
- What is being tested?
- Morphology and Morphology and Mass Spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2016to Dec 2017
- 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 21 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- any infertility etiology
- good previous response to IVF with ≥1 embryo
Who cannot join
- poor response to IVF previously
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University School of Medicine
Istanbul, 34093
Ercan Bastu, M.D., +90 532 413 41 95, ercan.bastu@istanbul.edu.tr
Ercan Bastu, M.D.
About this study
Official title: Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology: a Randomized Controlled Trial
Identification of the embryo with the highest potential to implant and establish an ongoing pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The optimal scenario is the transfer of a single embryo which gives rise to a singleton pregnancy. The current limitations in determination of embryos that have the highest implantation potential probably contribute to the low rates of pregnancy during IVF treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a 'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it provides a chance to evaluate them from the oocyte stage all the way to the blastocysts stage. Hence, in the first era of IVF, there were number of studies that evaluated this parameter and associated morphology with IVF success rates. On the other hand, it has been previously stated that the slight increase in pregnancy rates during IVF treatment is mostly likely a result of better practices in laboratory than morphological evaluation. Due to the limitations of morphological evaluation, several researchers have investigated adjunctive non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.
Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples needed minimal preparation; analytical analysis was rapid and large amounts of data was available. Hence, MS might be a promising approach for metabolomic profiling of embryo culture media.
- Conditions
- Embryo Selection, IVF, Morphology
- Being tested
- Morphology, Morphology and Mass Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphologyProcedure or surgery
Morphology and Mass SpectroscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Embryo Selection by Morphology | Active comparator | Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study Receives: Procedure: Morphology; Procedure: Morphology and Mass Spectroscopy |
| Embryo Selection by Morphology and Mass Spectroscopy | Active comparator | Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study. After dilution, embryo culture media will be analyzed by electrospray ionization quadrupole time-of-flight (ESI-QTOF) MS. The spectra will be collected in the negative ion mode. Abundance of ions in each spectrum will be further analyzed. Receives: Procedure: Morphology; Procedure: Morphology and Mass Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Clinical pregnancy will be defined as the presence of a fetal heartbeat using vaginal ultrasound at 6 weeks of amenorrhoea.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo SelectionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Fulya Hospital, Marmara University
- Responsible party
- Principal investigator, Ercan Bastu, Istanbul University
- Investigators
- Ercan Bastu, M.D., Principal investigator, Istanbul University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698488
- Sponsor's protocol ID
- 201603
- Status last verified
- Aug 2016
- First submitted
- 29 Feb 2016
- Last updated
- 30 Aug 2016
- 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 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02698488
- Acronym / sponsor ID
- 201603
- Conditions
- Embryo Selection, IVF, Morphology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Acibadem Fulya Hospital, Marmara University
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Mar 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.
Identification of the embryo with the highest potential to implant and establish an ongoing pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The optimal scenario is the transfer of a single embryo which gives rise to a singleton pregnancy. The current limitations in determination of embryos that have the highest implantation potential probably contribute to the low rates of pregnancy during IVF treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a 'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it provides a chance to evaluate them from the oocyte stage all the way to the blastocysts stage. Hence, in the first era of IVF, there were number of studies that evaluated this parameter and associated morphology with IVF success rates. On the other hand, it has been previously stated that the slight increase in pregnancy rates during IVF treatment is mostly likely a result of better practices in laboratory than morphological evaluation. Due to the limitations of morphological evaluation, several researchers have investigated adjunctive non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.
Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples needed minimal preparation; analytical analysis was rapid and large amounts of data was available. Hence, MS might be a promising approach for metabolomic profiling of embryo culture media.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embryo Selection by Morphology | Active comparator | Procedure: Morphology, Procedure: Morphology and Mass SpectroscopyEmbryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study |
| Embryo Selection by Morphology and Mass Spectroscopy | Active comparator | Procedure: Morphology, Procedure: Morphology and Mass SpectroscopyEmbryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study. After dilution, embryo culture media will be analyzed by electrospray ionization quadrupole time-of-flight (ESI-QTOF) MS. The spectra will be collected in the negative ion mode. Abundance of ions in each spectrum will be further analyzed. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- any infertility etiology
- good previous response to IVF with ≥1 embryo
Key exclusion criteria (1 listed)
- poor response to IVF previously
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 |
|---|---|---|
| Morphology | Procedure or surgery | Embryo Selection by Morphology, Embryo Selection by Morphology and Mass Spectroscopy |
| Morphology and Mass Spectroscopy | Procedure or surgery | Embryo Selection by Morphology, Embryo Selection by Morphology and Mass Spectroscopy |
Primary outcome
Clinical Pregnancy
Time frame: 3 months
Clinical pregnancy will be defined as the presence of a fetal heartbeat using vaginal ultrasound at 6 weeks of amenorrhoea.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Embryo Selection
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Interest of Morphokinetic Parameters of Early Embryonic Development in the Birth Rates in Vitro Fertilization
Reproductive Disorder
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Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development
Infertility
Not yet recruitingObservational study
Polygenic Embryo Selection
Polygenic Score
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AI-Assisted Euploid Embryo Selection for Single-Blastocyst Transfer in Women of Advanced Maternal Age
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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.
Ercan Bastu, M.D. principal investigator
Istanbul University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphology and Morphology and Mass Spectroscopy in people with Embryo Selection and IVF, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 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 30 Aug 2016. 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 Turkey (Türkiye). 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 Ercan Bastu, M.D. (+90 532 413 41 95, ercan.bastu@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy (time frame: 3 months). 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 30 Aug 2016.