A multicentre evaluation of the Elecsys ® anti-Müllerian hormone immunoassay for prediction of antral follicle count.

Autor: Jacobs MH; Fertility and IVF Center of Miami, 8950 North Kendall Drive, Suite 103, Miami FL 33176, USA. Electronic address: fivf@aol.com., Reuter LM; Midwest Fertility Specialists, 12188-A North Meridian Street, Suite 250, Carmel IN 46032, USA., Baker VL; Stanford Fertility Specialists, 1195 West Fremont Avenue, Sunnyvale CA 94087, USA., Craig LB; University of Oklahoma Health Sciences Center, 1100 North Lindsay Avenue, Oklahoma City OK 73104, USA., Sakkas D; Boston IVF, 130 Second Avenue, Waltham MA 02451, USA., Surrey E; Colorado Center for Reproductive Medicine, 10290 RidgeGate Circle, Lone Tree CO 80124, USA., Doody KJ; Center for Assisted Reproduction, 1701 Park PI Avenue, Bedford TX 76022, USA., Jungheim ES; Washington University Fertility and Reproductive Medicine Center, 4444 Forest Park Avenue No. 3100, St. Louis MO 63110, USA., Bayrak AB; LA IVF, 2080 Century Park, Los Angeles CA 90067, USA., Hund M; Roche Diagnostics International Ltd, Forrenstrasse 2, Rotkreuz 6343, Switzerland., Verhagen-Kamerbeek WDJ; Roche Diagnostics International Ltd, Forrenstrasse 2, Rotkreuz 6343, Switzerland., Pardue D; Roche Diagnostics Operations Inc., 9115 Hague Road, Indianapolis IN 46250-0457, USA., Buck K; Roche Diagnostics GmbH, Nonnenwald 2, Penzberg 82377, Germany., Timm B; Heartland Center for Reproductive Medicine, 7308 South 142nd Street, Omaha NE 68138, USA.
Jazyk: angličtina
Zdroj: Reproductive biomedicine online [Reprod Biomed Online] 2019 May; Vol. 38 (5), pp. 845-852. Date of Electronic Publication: 2019 Jan 08.
DOI: 10.1016/j.rbmo.2018.12.041
Abstrakt: Research Question: What concentration of anti-Müllerian hormone (AMH) corresponds to an antral follicle count (AFC) >15 for determination of ovarian reserve?
Design: A prospective study conducted at 13 US fertility clinics in women aged 21-44 years who presented for AFC evaluation by transvaginal ultrasound. Serum samples were collected at the time of AFC evaluation (menstrual cycle day 2-4). AMH concentrations were measured by the Elecsys ® AMH immunoassay; oestradiol and follicle-stimulating hormone (FSH) concentrations were also measured. The serum AMH cut-off able to detect AFC >15 with high sensitivity was determined (derivation cohort). Clinical performance of the AMH assay at the derived cut-off was evaluated (validation cohort). Receiver operating characteristic (ROC) analyses were also performed.
Results: In the derivation cohort (n = 306), an optimal serum AMH cut-off value of 1.77 ng/ml was determined to correspond to AFC >15 with 89.63% sensitivity and 69.01% specificity, using the Elecsys AMH assay. In the validation cohort (n = 856), this 1.77 ng/ml cut-off could identify women with an AFC >15 with a sensitivity of 88.34% and a specificity of 68.29%; corresponding positive predictive and negative predictive values were 75.19% and 84.34%, respectively. ROC analyses demonstrated that AMH performed better than oestradiol or FSH in predicting AFC, with area under the curves of 85.7%, 57.1% and 69.7%, respectively, in the validation cohort.
Conclusion: The Elecsys AMH immunoassay provides a robust and fully automated method to measure serum AMH levels. Women with AMH values below the cut-off of 1.77 ng/ml are unlikely to have AFC >15.
(Copyright © 2019 Roche Diagnostics Ltd. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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