NCT03740828

KIDScore D3 Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Vitrolife · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	KIDScore D3	Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.

Timeline

• Start date: 2016-09-20
• Primary completion: 2017-10-12
• Completion: 2017-10-12
• First posted: 2018-11-14
• Last updated: 2018-11-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study