KIDScore D3 Clinical Study

NCT ID: NCT03740828

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-20

Study Completion Date

2017-10-12

Brief Summary

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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

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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

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women undergoing IVF treatment

Device: KIDScore D3 study

KIDScore D3

Intervention Type DEVICE

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

Interventions

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KIDScore D3

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing IVF treatment

Exclusion Criteria

* Less than 5 actively dividing embryos
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vitrolife

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Belinda Dueholm, MSc

Role: PRINCIPAL_INVESTIGATOR

Vitrolife A/S

Locations

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Fertility Specialists Medical Group, Inc

San Diego, California, United States

Site Status

Laurel Fertility Care

San Francisco, California, United States

Site Status

Pacific Fertility

San Francisco, California, United States

Site Status

South Florida Institute Fro Reproductive Medicine

Miami, Florida, United States

Site Status

Midwest Fertility Institute

Carmel, Indiana, United States

Site Status

New York Fertility Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27609980 (View on PubMed)

Other Identifiers

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FU1028_Clinical study

Identifier Type: -

Identifier Source: org_study_id

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