Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

KIDScore D3 Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740828
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Vitrolife

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.

Condition or disease Intervention/treatment
Infertility 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.


Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing IVF treatment
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
European women undergoing IVF treatment and imaging of their embryos with the EmbryoScope system
Criteria

Inclusion Criteria:

  • Women undergoing IVF treatment

Exclusion Criteria:

  • Less than 5 actively dividing embryos

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
Fertility Specialists Medical Group, Inc
San Diego, California, United States, 92123
Laurel Fertility Care
San Francisco, California, United States, 94109
Pacific Fertility
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
Sponsors and Collaborators
Vitrolife
Investigators
Layout table for investigator information
Principal Investigator: Belinda Dueholm, MSc Vitrolife A/S

Additional Information:

Publications of Results:
Layout table for additonal information
Responsible Party: Vitrolife
ClinicalTrials.gov Identifier: NCT03740828     History of Changes
Other Study ID Numbers: FU1028_Clinical study
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data are confidential

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Vitrolife:
In vitro fertilization
Time-lapse
Assisted Reproduction

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female