KIDScore D3 Clinical Study
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|ClinicalTrials.gov Identifier: NCT03740828|
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment|
|Infertility||Device: KIDScore D3|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||81 participants|
|Target Follow-Up Duration:||8 Weeks|
|Official Title:||KIDScore D3 Clinical Study|
|Actual Study Start Date :||September 20, 2016|
|Actual Primary Completion Date :||October 12, 2017|
|Actual Study Completion Date :||October 12, 2017|
Women undergoing IVF treatment
Device: KIDScore D3 study
Device: KIDScore D3
Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.
- 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.
- Embryo-Level Diagnostic Performance Measures [ Time Frame: 1-2 Months ]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.
- Top 2 Embryo Analysis [ Time Frame: 1-2 Months ]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)
- Treatment Level Analyses [ Time Frame: 1-2 Months ]For the performance assessments of treatment level analyses the predicted blastocyst outcome were compared with the actual blastocyst outcome with each treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740828
|United States, California|
|Fertility Specialists Medical Group, Inc|
|San Diego, California, United States, 92123|
|Laurel Fertility Care|
|San Francisco, California, United States, 94109|
|San Francisco, California, United States, 94133|
|United States, Florida|
|South Florida Institute Fro Reproductive Medicine|
|Miami, Florida, United States, 33143|
|United States, Indiana|
|Midwest Fertility Institute|
|Carmel, Indiana, United States, 46032|
|United States, New York|
|New York Fertility Institute|
|New York, New York, United States, 10028|
|Principal Investigator:||Belinda Dueholm, MSc||Vitrolife A/S|