KIDScore D3 Clinical Study
1 other identifier
observational
81
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2017
CompletedFirst Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedNovember 14, 2018
November 1, 2018
1.1 years
November 5, 2018
November 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1-2 months
Secondary Outcomes (3)
Embryo-Level Diagnostic Performance Measures
1-2 Months
Top 2 Embryo Analysis
1-2 Months
Treatment Level Analyses
1-2 Months
Study Arms (1)
Women undergoing IVF treatment
Device: KIDScore D3 study
Interventions
Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.
Eligibility Criteria
European women undergoing IVF treatment and imaging of their embryos with the EmbryoScope system
You may qualify if:
- Women undergoing IVF treatment
You may not qualify if:
- Less than 5 actively dividing embryos
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vitrolifelead
Study Sites (6)
Fertility Specialists Medical Group, Inc
San Diego, California, 92123, United States
Laurel Fertility Care
San Francisco, California, 94109, United States
Pacific Fertility
San Francisco, California, 94133, United States
South Florida Institute Fro Reproductive Medicine
Miami, Florida, 33143, United States
Midwest Fertility Institute
Carmel, Indiana, 46032, United States
New York Fertility Institute
New York, New York, 10028, United States
Related Publications (1)
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.
PMID: 27609980RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belinda Dueholm, MSc
Vitrolife A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 14, 2018
Study Start
September 20, 2016
Primary Completion
October 12, 2017
Study Completion
October 12, 2017
Last Updated
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share
Patient data are confidential