KIDScore D3 Clinical 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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: KIDScore D3

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Fertility Specialists Medical Group, Inc
    • San Francisco, California, United States, 94109
      • Laurel Fertility Care
    • San Francisco, California, United States, 94133
      • Pacific Fertility
  • Florida
    • Miami, Florida, United States, 33143
      • South Florida Institute Fro Reproductive Medicine
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Midwest Fertility Institute
  • New York
    • New York, New York, United States, 10028
      • New York Fertility Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

European women undergoing IVF treatment and imaging of their embryos with the EmbryoScope system

Description

Inclusion Criteria:

• Women undergoing IVF treatment

Exclusion Criteria:

• Less than 5 actively dividing embryos

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women undergoing IVF treatment; Device: KIDScore D3 study	Device: KIDScore D3; Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	1-2 Months

Collaborators and Investigators

• Sponsor: Vitrolife
• Investigators: Principal Investigator: Belinda Dueholm, MSc, Vitrolife A/S

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): October 12, 2017
• Study Completion (Actual): October 12, 2017

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: In vitro fertilization; Assisted Reproduction; Time-lapse
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: FU1028_Clinical study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data are confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No