KIDScore D3 Clinical Study

Infertility Clinical Trial

Official title:

KIDScore D3 Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740828
• Other study ID #: FU1028_Clinical study
• Status: Completed
• Start date: September 20, 2016
• Est. completion date: October 12, 2017

Study information

• Verified date: November 2018
• Source: Vitrolife
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 12, 2017
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women undergoing IVF treatment

Exclusion Criteria:

• Less than 5 actively dividing embryos

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• KIDScore D3
Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.

Locations

Country	Name	City	State
United States	Midwest Fertility Institute	Carmel	Indiana
United States	South Florida Institute Fro Reproductive Medicine	Miami	Florida
United States	New York Fertility Institute	New York	New York
United States	Fertility Specialists Medical Group, Inc	San Diego	California
United States	Laurel Fertility Care	San Francisco	California
United States	Pacific Fertility	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Vitrolife

Country where clinical trial is conducted

United States, 

References & 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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