Clinical trial NCT03740828: KIDScore D3 Clinical Study
Official title: KIDScore D3 Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: In vitro fertilization
Time-lapse
Assisted Reproduction
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 81
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: European women undergoing IVF treatment and imaging of their embryos with the EmbryoScope system

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.

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.

Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF treatment

Exclusion Criteria:

* Less than 5 actively dividing embryos

Primary outcomes:
measure: Prediction of blastocyst outcome
timeFrame: 1-2 months
Secondary outcomes:
measure: Embryo-Level Diagnostic Performance Measures
timeFrame: 1-2 Months
measure: Top 2 Embryo Analysis
timeFrame: 1-2 Months
measure: Treatment Level Analyses
timeFrame: 1-2 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Fertility Specialists Medical Group, Inc
state: California
city: San Francisco
country: United States
facility: Laurel Fertility Care
state: California
city: San Francisco
country: United States
facility: Pacific Fertility
state: California
city: Miami
country: United States
facility: South Florida Institute Fro Reproductive Medicine
state: Florida
city: Carmel
country: United States
facility: Midwest Fertility Institute
state: Indiana
city: New York
country: United States
facility: New York Fertility Institute
state: New York
Study officials:
affiliation: Vitrolife A/S
name: Belinda Dueholm, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.