InfertilityNCT03740828
KIDScore D3 Clinical Study
An observational study of Infertility, run by Vitrolife at 6 sites in United States.
Trial summary
The aim of this study is to demonstrate that the KIDScore D3 may be used to identify those embryos on Day 3 that are most likely to form blastocysts. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- KIDScore D3
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Sep 2016to 12 Oct 2017
- How long will I take part?
- 8 Weeks
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: European women undergoing IVF treatment and imaging of their embryos with the EmbryoScope system
Who may be able to join
- Women undergoing IVF treatment
Who cannot join
- Less than 5 actively dividing embryos
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Midwest Fertility Institute
Carmel, Indiana, 46032
South Florida Institute Fro Reproductive Medicine
Miami, Florida, 33143
New York Fertility Institute
New York, New York, 10028
Fertility Specialists Medical Group, Inc
San Diego, California, 92123
Laurel Fertility Care
San Francisco, California, 94109
Pacific Fertility
San Francisco, California, 94133
About this study
The aim of this study is to demonstrate that the KIDScore D3 may be used to identify those embryos on Day 3 that are most likely to form blastocysts.
Read the detailed description
The safety and effectiveness of the KIDScore D3 was investigated in a prospective study. The study was performed as a single arm, multicenter clinical study conducted at six sites in the United States. This was a non-interventional clinical study where the KIDScore D3 was not used during patient treatment. Briefly, the purpose of the study was to collect data to evaluate the safety and effectiveness of the KIDScore D3's ability to predict which embryos are most likely to develop to blastocyst stage. This was evaluated by using the KIDScore D3 as adjunct information to traditional morphological grading. Imaging data was collected on embryos cultured to day 5. Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores.
This study aims at analyzing the utilization of established morphology methods with adjunct outcome of an algorithm (KIDScore D3) that provides a score (1 - 5) from timings of morphokinetic events.
A double-blinded, multi-center study, designed to evaluate the odds ratios and other measures for outcomes of methodologies used for embryo assessment: day 3 morphology alone and day 3 morphology with KIDScore D3 results as adjunct information.
- Conditions
- Infertility
- Being tested
- KIDScore D3
- Keywords
- In vitro fertilization, Time-lapse, Assisted Reproduction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIDScore D3Device
Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing IVF treatment | Device: KIDScore D3 study Receives: Device: KIDScore D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of blastocyst outcome
The primary endpoint of this study was to assess the association between the adjunct prediction using KIDScore D3 of blastocyst outcome and the actual blastocyst outcome. The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1, for good/fair embryos. This will demonstrate that adjunctive use of KIDScore D3 leads to embryologist predictions for Day 5 blastulation that is informative for blastocysts outcome.
Measured: 1-2 months
Secondary outcomes (3)
Embryo-Level Diagnostic Performance Measures
The specificity was calculated for morphology alone prediction and compared to the specificity for adjunct prediction. Comparable calculations was done for sensitivity, negative predictive value, positive predictive value, negative likelihood ratio and positive likelihood ratio. The above measures were given both as an overall and for each panelist, assessing the performance measures without and with adjunct prediction.
Measured: 1-2 Months
Top 2 Embryo Analysis
This analysis included the top 2 embryos selected by each panelist based on morphology alone. The assessment of whether or not the OR is significantly greater than 1, was done by the use of a generalized linear mixed model (GLMM)
Measured: 1-2 Months
Treatment Level Analyses
For the performance assessments of treatment level analyses the predicted blastocyst outcome were compared with the actual blastocyst outcome with each treatment.
Measured: 1-2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start20 Sep 2016
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 81 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belinda Dueholm, MSc, Principal investigator, Vitrolife A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740828
- Sponsor's protocol ID
- FU1028_Clinical study
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Patient data are confidential
Publications
Petersen BM, Boel M, Montag M, Gardner DK. Development of a generally applicable morphokinetic algorithm capable of predicting the implantation potential of embryos transferred on Day 3. Hum Reprod. 2016 Oct;31(10):2231-44. doi: 10.1093/humrep/dew188. Epub 2016 Sep 8.
PubMed 27609980
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIDScore D3 Clinical Study
- ClinicalTrials.gov ID
- NCT03740828
- Acronym / sponsor ID
- FU1028_Clinical study
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Time-lapse, Assisted Reproduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 14 Nov 2018 (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 aim of this study is to demonstrate that the KIDScore D3 may be used to identify those embryos on Day 3 that are most likely to form blastocysts.
Detailed description
The safety and effectiveness of the KIDScore D3 was investigated in a prospective study. The study was performed as a single arm, multicenter clinical study conducted at six sites in the United States. This was a non-interventional clinical study where the KIDScore D3 was not used during patient treatment. Briefly, the purpose of the study was to collect data to evaluate the safety and effectiveness of the KIDScore D3's ability to predict which embryos are most likely to develop to blastocyst stage. This was evaluated by using the KIDScore D3 as adjunct information to traditional morphological grading. Imaging data was collected on embryos cultured to day 5. Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores.
This study aims at analyzing the utilization of established morphology methods with adjunct outcome of an algorithm (KIDScore D3) that provides a score (1 - 5) from timings of morphokinetic events.
A double-blinded, multi-center study, designed to evaluate the odds ratios and other measures for outcomes of methodologies used for embryo assessment: day 3 morphology alone and day 3 morphology with KIDScore D3 results as adjunct information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF treatment | – | Device: KIDScore D3Device: KIDScore D3 study |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- European women undergoing IVF treatment and imaging of their embryos with the EmbryoScope system
Key inclusion criteria (1 listed)
- Women undergoing IVF treatment
Key exclusion criteria (1 listed)
- Less than 5 actively dividing embryos
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 |
|---|---|---|
| KIDScore D3Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters. | Device | Women undergoing IVF treatment |
Primary outcome
Prediction of blastocyst outcome
Time frame: 1-2 months
The primary endpoint of this study was to assess the association between the adjunct prediction using KIDScore D3 of blastocyst outcome and the actual blastocyst outcome. The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1, for good/fair embryos. This will demonstrate that adjunctive use of KIDScore D3 leads to embryologist predictions for Day 5 blastulation that is informative for blastocysts outcome.
3 secondary outcomes
Embryo-Level Diagnostic Performance Measures
Time frame: 1-2 Months
Top 2 Embryo Analysis
Time frame: 1-2 Months
Treatment Level Analyses
Time frame: 1-2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Results publication: PubMed 27609980Petersen BM, Boel M, Montag M, Gardner DK. Development of a generally applicable morphokinetic algorithm capable of predicting the implantation potential of embryos transferred on Day 3. Hum Reprod. 2016 Oct;31(10):2231-44. doi: 10.1093/humrep/dew188. Epub 2016 Sep 8.
- Individual participant dataSharing planned: No. Patient data are confidential
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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.
Belinda Dueholm, MSc principal investigator
Vitrolife A/S
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Vitrolife at 6 sites in United States.
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 1 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: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prediction of blastocyst outcome (time frame: 1-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740828, which also lists 1 linked publication.
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 2018.