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

REPRODUCTIVE BIOMEDICINE ONLINE

卷:38

Article

Jacobs, Michael H.¹  Reuter, Laura M.²  Baker, Valerie L.³  Craig, LaTasha B.⁴  Sakkas, Denny⁵  Surrey, Eric⁶  Doody, Kevin J.⁷  Jungheim, Emily S.⁸  Bayrak, Aykut B.⁹  Hund, Martin¹⁰  Verhagen-Kamerbeek, Wilma D. J.¹⁰  Pardue, Deborah¹¹  Buck, Katharina¹²  Timm, Barbara¹³ 

[1] Fertil & IVF Ctr Miami, 8950 North Kendall Dr,Suite 103, Miami, FL 33176 USA

[2] Midwest Fertil Specialists, 12188-A North Meridian St,Suite 250, Carmel, IN 46032 USA

[3] Stanford Fertil Specialists, 1195 West Fremt Ave, Sunnyvale, CA 94087 USA

[4] Univ Oklahoma, Hlth Sci Ctr, 1100 North Lindsay Ave, Oklahoma City, OK 73104 USA

[5] Boston IVF, 130 Second Ave, Waltham, MA 02451 USA

[6] Colorado Ctr Reprod Med, 10290 RidgeGate Circle, Lone Tree, CO 80124 USA

[7] Ctr Assisted Reprod, 1701 Pk Pl Ave, Bedford, TX 76022 USA

[8] Washington Univ, Fertil & Reprod Med Ctr, 4444 Forest Pk Ave 3100, St Louis, MO 63110 USA

[9] LA IVF, 2080 Century Pk, Los Angeles, CA 90067 USA

[10] Roche Diagnost Int Ltd, Forrenstr 2, CH-6343 Rotkreuz, Switzerland

[11] Roche Diagnost Operat Inc, 9115 Hague Rd, Indianapolis, IN 46250 USA

[12] Roche Diagnost GmbH, Nonnenwald 2, D-82377 Penzberg, Germany

[13] Heartland Ctr Reprod Med, 7308 South 142nd St, Omaha, NE 68138 USA

关键词: Anti-Mullerian hormone;    Antral follicle count;    Ommunoassay;    Ovarian reserve;   

DOI  :  10.1016/j.rbmo.2018.12.041

来源: Elsevier

【 摘 要 】

Research question: What concentration of anti-Mullerian 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 (R) 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%, 571% 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.

【 授权许可】

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