Infertility Clinical Trial
Official title:
KIDScore D3 Clinical Study
Verified date | November 2018 |
Source | Vitrolife |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Vitrolife |
United States,
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
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 |
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