The accuracy and reproducibility of the endometrial receptivity array is superior to histology as a diagnostic method for endometrial receptivity

Objective To compare the accuracy and reproducibility of the endometrial receptivity array (ERA) versus standard histologic methods. Design A comparative prospective study (May 2008–May 2012). Setting University-affiliated infertility clinic. Patient(s) Eighty-six healthy oocyte donors, regularly cy...

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Bibliographic Details
Published in:Fertility and sterility 2013-02, Vol.99 (2), p.508-517
Main Authors: Díaz-Gimeno, Patricia, Ph.D, Ruiz-Alonso, Maria, Ph.D, Blesa, David, Ph.D, Bosch, Nuria, M.D, Martínez-Conejero, José A., Ph.D, Alamá, Pilar, M.D, Garrido, Nicolás, Ph.D, Pellicer, Antonio, M.D, Simón, Carlos, M.D
Format: Article
Language:English
Subjects:
Adult
Artificial Intelligence
Biomarkers - analysis
Biopsy - methods
body mass index
consistency
Diagnosis, Computer-Assisted - methods
diagnostic accuracy
diagnostic techniques
Endometrial receptivity
endometrium
Endometrium - cytology
Endometrium - metabolism
Female
gene expression
histologic dating
histology
Humans
Internal Medicine
luteinizing hormone
machine-learning prediction
menstrual cycle
Obstetrics and Gynecology
oocytes
Ovulation Detection - methods
patients
principal component analysis
prospective studies
Reproducibility of Results
Sensitivity and Specificity
women
Young Adult
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Summary:Objective To compare the accuracy and reproducibility of the endometrial receptivity array (ERA) versus standard histologic methods. Design A comparative prospective study (May 2008–May 2012). Setting University-affiliated infertility clinic. Patient(s) Eighty-six healthy oocyte donors, regularly cycling, aged 20–34 years with a body mass index (BMI) of 19–25 kg/m2. Intervention(s) Endometrial biopsies were collected throughout the menstrual cycle. For the accuracy study, 79 samples were grouped into two cohorts: the training set (n = 79) for ERA machine-learning training and dating, and a dating subset (n = 49) for comparison between histologic and ERA dating. For the reproducibility study, seven women underwent ERA testing and it was repeated in the same patients on the same day of their cycle 29–40 months later. Main Outcome Measure(s) Concordance of histologic and ERA dating related to LH as a reference, and interobserver variability between pathologists were statistically analyzed by the quadratic weighted Kappa index. The ERA reproducibility was tested and its gene expression visualized by principal component analysis. Result(s) For each pathologist, concordance against LH peak yielded values of 0.618 (0.446–0.791) and 0.685 (0.545–0.824). Interobserver variability between pathologists yielded a Kappa index of 0.622 (0.435–0.839). Concordance for ERA dating against LH peak showed a value of 0.922 (0.815–1.000). Reproducibility of the ERA test was 100% consistent. Conclusion(s) The ERA is more accurate than histologic dating and is a completely reproducible method for the diagnosis of endometrial dating and receptivity status.
ISSN:0015-0282
1556-5653
DOI:10.1016/j.fertnstert.2012.09.046