@article{1b9b46150a504486b17a15eb795a6b21,
title = "Poor reproducibility of percentage of normally shaped sperm using the World Health Organization Fifth Edition strict grading criteria",
abstract = "Objective: To determine the reproducibility of the World Health Organization Fifth Edition (WHO5) strict grading methodology by comparing the percentage of morphologically normal sperm (PNS) recorded by the core laboratory with results obtained at the fertility centers participating in a multisite clinical trial. Design: Secondary cohort analysis of data from the Males, Antioxidants, and Infertility trial. Setting: Fertility centers. Patient(s): Semen values of 171 men participating in a multicenter, double-blind, randomized, placebo-controlled trial evaluating the effect of antioxidants on male fertility. Intervention(s): Not applicable. Main Outcome Measure(s): Strict morphology expressed as PNS as determined at each fertility center and the core central laboratory for the same semen sample. Result(s): No correlation was found in the PNS values for the same semen sample between the core laboratory and fertility center laboratories either as a group or by individual site. Interobserver agreement was similarly low (κ = 0.05 and 0.15) between the core and fertility laboratories as a group for strict morphology, categorized by the WHO5 lower reference limits of 4% and 0, respectively. Moderate agreement was found between the core and 2 individual fertility laboratories for the cutoff value of 0 (κ = 0.42 and 0.57). The remainder of the comparisons demonstrated poor to fair agreement. Conclusion(s): Strict morphology grading using the WHO5 methodology demonstrated overall poor reproducibility among a cohort of experienced fertility laboratories. This lack of correlation and agreement in the PNS values calls into question the reproducibility, and thereby the potential applicability, of sperm strict morphology testing.",
keywords = "Semen analysis, male factor infertility, quality control, spermatozoa, teratozoospermia",
author = "{Reproductive Medicine Network} and Baker, {Karen C.} and Steiner, {Anne Z.} and Hansen, {Karl R.} and Barnhart, {Kurt T.} and Cedars, {Marcelle I.} and Legro, {Richard S.} and Diamond, {Michael P.} and Krawetz, {Stephen A.} and Rebecca Usadi and Baker, {Valerie L.} and Coward, {R. Matthew} and Fangbai Sun and Robert Wild and Puneet Masson and Smith, {James F.} and Nanette Santoro and Heping Zhang",
note = "Funding Information: K.C.B. reports honoraria for the American Urologic Association Oral Board Review Course. A.Z.S. reports grant from the NICHD/NIH for the submitted work; consulting fees from Seikagaku Corporation and Prima-Temp; and Editor-in-Chief, F&S Reviews. K.R.H. reports grant NIH U10HD077680 from the NIH/NICHD for the submitted work, grants R03HD101893 and R01HD100305 from the NIH; and consulting fees from AblaCare outside the submitted work. K.T.B. has nothing to disclose. M.I.C. has nothing to disclose. R.S.L. reports grants from NIH R01 HD091350-04, NIH/NCCIH R01AT009484-02, Guerbet USA, Data Coordinator Center for the RMN U10HD055925-10REV, Hass Avocado Board; Penn State Clinical and Translational Science Institute, NIH/NICHS R01 HD083323-04, NIH R01HD100630-01, National Center for Advancing Translational Sciences UL1 TR002014, NIH U10 HD038992-15 (Ext), NIH/NICHD U10 HD038992-10 (Ext), NIH/NHLBI R01 HL119245-05, and Patty Brisben Foundation for Women{\textquoteright}s Sexual Health; consulting fees from Insudd (2020), Bayer (2019), Fractyl (2019), AbbVie (2019), and Ferring (2018); honorarium/payment for lectures from the National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Shandong University, Jinan, China; Member, Steering Committee, Eastern Siberia PCOS Epidemiology & Phenotype study, Scientific Center of Family Health and Human Reproduction, Irkutsk, Russian Federation; and Member, International Advisory Panel, Developing, disseminating and implementing a core outcome set for infertility, Funded by the Royal Society of New Zealand Catalyst Fund and the University of Auckland, New Zealand. M.P.D. reports grant U10HD039005 from the NIH/NICHD for the submitted work. S.A.K. reports funding from the NICHD and Endowed Chair to his institution for the submitted work, royalties from Springer, consulting fees from Taylor and Frances, and advisory board for KINBRE outside the submitted work. R.U. has nothing to disclose. V.L.B. has nothing to disclose. M.C. reports grant U10HD077844 from the NIH/NICHD for the submitted work. F.S. has nothing to disclose. R.W. has nothing to disclose. P.M. has nothing to disclose. J.F.S. has nothing to disclose. N.S. has nothing to disclose. H.Z. reports grants from the NIH and NSF for the submitted work. Funding Information: This work was supported by National Institutes of Health (NIH)/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Grants R25HD075737 (to N.S.), U10HD077844 (to A.Z.S.), U10HD077680 (to K.R.H., V.L.B.), 1U10 HD077841 (to M.I.C.), U10HD027049 (to C.C.), U10HD038992 (to R.S.L.), U10HD039005 (to M.P.D., R.U., S.K.), and U10HD055925 and UL1 TR001863 (to H.Z.). Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = jun,
doi = "10.1016/j.xfre.2022.03.003",
language = "English (US)",
volume = "3",
pages = "110--115",
journal = "F and S Reports",
issn = "2666-3341",
publisher = "Elsevier BV",
number = "2",
}