Test Catalog

Test Id : AMH1

Antimullerian Hormone, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing ovarian status, including ovarian reserve and ovarian responsiveness, as part of an evaluation for infertility and assisted reproduction protocols

 

Assessment of menopausal status, including premature ovarian failure

 

Evaluation of infants with ambiguous genitalia and other intersex conditions

 

Evaluating testicular function in infants and children

 

Monitoring patients with antimullerian hormone-secreting ovarian granulosa cell tumors

Highlights

Antimullerian hormone (AMH) is produced by Sertoli cells of the testis in male individuals and by ovarian granulosa cells in female individuals.

 

In female individuals, AMH is used as a marker for ovarian reserve and in the assessment of ovarian responsiveness as part of evaluation of infertility and in assistance with reproductive therapy.

 

In male individuals, AMH is used in the evaluation of disorders of sexual development and male fertility.

Method Name
A short description of the method used to perform the test

Electrochemiluminescent Immunoassay (ECLIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Antimullerian Hormone, S

Aliases
Lists additional common names for a test, as an aid in searching

Mullerian inhibiting factor (MIF)

Mullerian-inhibiting hormone (MIH)

Mullerian-inhibiting substance (MIS)

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject-acceptable to 1000 mg/dL
Gross lipemia OK
Gross icterus Reject-acceptable to 66 mg/dL

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
Frozen 180 days
Ambient 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing ovarian status, including ovarian reserve and ovarian responsiveness, as part of an evaluation for infertility and assisted reproduction protocols

 

Assessment of menopausal status, including premature ovarian failure

 

Evaluation of infants with ambiguous genitalia and other intersex conditions

 

Evaluating testicular function in infants and children

 

Monitoring patients with antimullerian hormone-secreting ovarian granulosa cell tumors

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Antimullerian hormone (AMH), also known as mullerian-inhibiting substance, is a dimeric glycoprotein hormone belonging to the transforming growth factor-beta family. It is produced by Sertoli cells of the testis in males and by ovarian granulosa cells in females. Expression during male fetal development prevents the mullerian ducts from developing into the uterus, resulting in development of the male reproductive tract. In the absence of AMH, the mullerian ducts and structures develop into the female reproductive tract. AMH serum concentrations are elevated in boys under 2 years old and then progressively decrease until puberty, when there is a sharp decline. In female individuals, serum AMH concentrations are very low at birth, peaking after puberty, decrease progressively thereafter with age, and become undetectable at menopause.

 

Because of the gender differences in AMH concentrations, its changes in circulating concentrations with sexual development, and its specificity for Sertoli and granulosa cells, measurement of AMH has utility in the assessment of gender, gonadal function, fertility, and as a gonadal tumor marker.

 

In female individuals, AMH is considered an ovarian reserve marker. It correlates with the primordial follicle pool, has an inverse correlation with chronologic age, predicts ovarian response in assisted reproductive therapy, and has been suggested to be predictive of the timing of the onset of menopause. In contrast to other markers of ovarian reserve that show significant fluctuations during the menstrual cycle, serum AMH concentrations have been shown to be relatively stable. Women with higher concentrations of AMH have a better response to ovarian stimulation and tend to produce more retrievable oocytes than women with low or undetectable AMH. Women at risk of ovarian hyperstimulation syndrome after gonadotropin administration can have significantly elevated AMH concentrations. Polycystic ovarian syndrome can elevate serum AMH concentrations because it is associated with the presence of large numbers of small follicles.

 

AMH measurements are commonly used to evaluate testicular presence and function in infants with intersex conditions or ambiguous genitalia and to distinguish between cryptorchidism and anorchia in male infants.

 

Serum AMH concentrations are increased in some patients with ovarian granulosa cell tumors, which comprise approximately 10% of ovarian tumors. AMH, along with related tests including inhibin A and B (INHA / Inhibin A, Tumor Marker, Serum; INHB / Inhibin B, Serum; INHAB / Inhibin A and B, Tumor Marker, Serum), estradiol (EEST / Estradiol, Serum), and cancer antigen 125 (CA25 / Cancer Antigen 125 [CA 125], Serum), can be useful for diagnosing and monitoring these patients.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Males

<2 years: 18-283 ng/mL

2-12 years: 8.9-109 ng/mL

>12 years: <13 ng/mL

 

Females

<3 years: 0.11-4.2 ng/mL

3-6 years: 0.21-4.9 ng/mL

7-11 years: 0.36-5.9 ng/mL

12-14 years: 0.49-6.9 ng/mL

15-19 years: 0.62-7.8 ng/mL

20-24 years: 1.2-12 ng/mL

25-29 years: 0.89-9.9 ng/mL

30-34 years: 0.58-8.1 ng/mL

35-39 years: 0.15-7.5 ng/mL

40-44 years: 0.03-5.5 ng/mL

45-50 years: <2.6 ng/mL

51-55 years: <0.88 ng/mL

>55 years: <0.03 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Menopausal women or women with premature ovarian failure of any cause, including after cancer chemotherapy, have very low anti-mullerian hormone (AMH) levels.

 

While the optimal AMH concentrations for predicting response to in vitro fertilization are still being established, it is accepted that AMH concentrations in the perimenopausal to menopausal range indicate minimal to absent ovarian reserve. Depending on patient age, ovarian stimulation is likely to fail in such patients.

 

AMH may be used as a surrogate to antral follicle count (AFC) at day 2 to 4 of the menstrual cycle to determine ovarian reserve. Women with an AFC greater than 15 are identified as having high ovarian reserve. In this context a Roche AMH concentration greater than 1.77 ng/mL at day 2 to 4 of the menstrual cycle, identified women with an AFC greater than 15 with 88.3% sensitivity and 68.3% specificity.(1)

 

Controlled ovarian stimulation (COS) with exogenous gonadotropin is an essential step of in-vitro fertilization (IVF) protocols. Using the Roche AMH assay, a cut-off of 2.10 ng/mL is correlated with the response categories in women undergoing COS using a gonadotropin-releasing hormone antagonist protocol. A 2.10 ng/mL cutoff provided reliable prediction of hyper-response to COS(2). Sensitivity for the detection of hyperresponsive individuals was 81.3%, and the negative predictive value for ruling out hyperresponse was 96.6%. The 2.10 ng/mL cutoff identified 88.9% of patients with a poor response.(2)

 

In patients with polycystic ovarian syndrome, AMH concentrations may be 2- to 5-fold higher than age-appropriate reference range values. Such high levels predict anovulatory and irregular cycles.

 

In children with intersex conditions, an AMH result above the normal female range is predictive of the presence of testicular tissue, while an undetectable value suggests its absence.

 

In boys suspected of cryptorchidism, a measurable AMH concentration is predictive of undescended testes, while an undetectable value is highly suggestive of anorchia or functional failure.

 

Klinefelter syndrome is characterized by accelerated germ cell depletion and occurs in approximately 10% to 12% of men presenting with nonobstructive azoospermia. In these patients, serum AMH concentrations are within the reference interval until puberty, and thereafter, AMH concentrations decline to abnormally low or undetectable.

 

Pubertal delay and congenital hypogonadotropic hypogonadism (HH) share the same clinical manifestation of delayed sexual maturation in prepubertal boys. Levels of gonadotropin and testosterone are very low in prepubertal boys and therefore have little clinical significance; thus, AMH measurements are useful in the differential diagnosis of pubertal delay and congenital HH. In patients with congenital HH, AMH concentrations are abnormally low, while in pubertal delay AMH concentrations will be within the prepubertal reference interval.

 

Granulosa cell tumors of the ovary may secrete AMH, inhibin A, and inhibin B. Elevated levels of any of these markers can indicate the presence of such a neoplasm in a woman with an ovarian mass. Levels should fall with successful treatment. Rising levels indicate tumor recurrence or progression.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Interference was observed at biotin concentrations above 30 ng/mL. Samples should not be taken from patients receiving therapy with high biotin doses until at least 12 hours following the last biotin administration.

 

The following drugs may interfere with this test, Cetrotide (cetrorelix), Ovitrelle, Endometrin (progesterone), and follistatin: do not use this test to analyze samples from patients who have received 1 or more of these products within 1 to 2 weeks of testing.

 

There is no high-dose hook effect at AMH concentrations up to 1400 ng/mL.

 

In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. The laboratory should be alerted if the result does not correlate with the clinical presentation.

 

For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.

 

AMH immunoassays are not standardized, and values obtained with different assay methods or kits may be different and cannot be used interchangeably.

 

If using as a tumor marker, test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Jacobs MH, Reuter LM, Baker VL, et al: A multicentre evaluation of the Elecsys anti-Mullerian hormone immunoassay for prediction of antral follicle count. Reprod Biomed Online. 2019 May;38(5):845-852

2. Anckaert E, Denk B, He Y, Torrance HL, Broekmans F, Hund M: Evaluation of the Elecsys anti-Mullerian hormone assay for the prediction of hyper-response to controlled ovarian stimulation with a gonadotrophin-releasing hormone antagonist protocol. Eur J Obstet Gynecol Reprod Biol. 2019 May;236:133-138

3. Bedenk J, Vrtacnik-Bokal E, Virant-Klun I: The role of anti-Mullerian hormone (AMH) in ovarian disease and infertility. J Assist Reprod Genet. 2020 Jan;37(1):89-100

4. Xu HY, Zhang HX, Xiao Z, Qiao J, Li R: Regulation of anti-Mullerian hormone (AMH) in males and the associations of serum AMH with the disorders of male fertility. Asian J Androl. 2019 Mar-Apr;21(2):109-114

5. Grinspon RP, Bergada I, Rey RA: Male hypogonadism and disorders of sex development. Front Endocrinol (Lausanne). 2020 April15;11:211

6. Shankar RK, Dowlut-McElroy T, Dauber A, Gomez-Lobo V: Clinical utility of anti-Mullerian hormone in pediatrics. J Clin Endocrinol Metab. 2021 Sep 19;dgab687. doi: 10.1210/clinem/dgab687. Epub ahead of print

Method Description
Describes how the test is performed and provides a method-specific reference

The Roche Elecsys AMH (anti-mullerian hormone) assay is a 2-site immunometric sandwich assay using electrochemiluminescence detection. Patient specimen, biotinylated monoclonal AMH-specific antibody, and monoclonal AMH-specific antibody labeled with a ruthenium react to form a complex. Streptavidin-coated microparticles act as the solid phase to which the complex becomes bound. Voltage is applied to the electrode inducing a chemiluminescent emission from the ruthenium, which is then measured against a calibration curve to determine the amount of AMH in the patient specimen.(Package insert: Elecsys AMH, Roche Diagnostics; 2.0 English 04/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83520

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
AMH1 Antimullerian Hormone, S 83104-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
AMH1 Antimullerian Hormone, S 83104-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports