Reproductive Endocrinology Reference Intervals for Transgender Men on Stable Hormone Therapy

2020 ◽  
Author(s):  
Dina N Greene ◽  
Robert L Schmidt ◽  
Gabrielle Winston-McPherson ◽  
Jessica Rongitsch ◽  
Katherine L Imborek ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Free Testosterone ◽  
Dehydroepiandrosterone Sulfate ◽  
Reference Intervals ◽  
Total Testosterone ◽  
Primary Care Clinics ◽  
Endocrine Hormones ◽  
Transgender Men

Abstract Background Gender-affirming therapy with testosterone is commonly prescribed to aid in the masculinization of transgender men. Sex-hormone concentrations are routinely measured, but interpretation of results can be difficult due to the lack of published reference intervals. Methods Healthy transgender individuals who had been prescribed testosterone (n = 82) for at least a year were recruited from internal medicine and primary care clinics that specialize in transgender medical care. Total testosterone and estradiol were measured using immunoassay and mass spectrometry; LH, FSH, SHBG, prolactin, progesterone, anti-Müllerian hormone (AMH), and dehydroepiandrosterone sulfate (DHEAS) were measured using immunoassay; free testosterone was calculated. Reference intervals (central 95%) were calculated according to Clinical Laboratory Standards Institute guidelines. Results When evaluating general endocrine laboratory tests in people using masculinizing hormones, reference intervals for cisgender men can be applied for total and free testosterone and SHBG and reference intervals for cisgender women can be applied for prolactin. Reference intervals for estradiol, LH, FSH, AMH, and DHEAS differ from those used for cisgender men and cisgender women, and therefore should be interpreted using intervals specific to the transmasculine population. For testosterone and estradiol, results from immunoassays were clinically equivalent to mass spectrometry. Conclusion Masculinizing hormones will alter the concentrations of commonly evaluated endocrine hormones. Providers and laboratories should use appropriate reference intervals to interpret the results of these tests.

Reproductive Endocrinology Reference Intervals for Transgender Women on Stable Hormone Therapy

2020 ◽  
Author(s):  
Dina N Greene ◽  
Robert L Schmidt ◽  
Gabrielle Winston McPherson ◽  
Jessica Rongitsch ◽  
Katherine L Imborek ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Hormone Therapy ◽  
Free Testosterone ◽  
Reference Intervals ◽  
Transgender Women ◽  
Reproductive Hormones ◽  
Sex Hormone Binding Globulin ◽  
Total Testosterone ◽  
Significant Variable ◽  
Reproductive Endocrinology

Abstract Background Transgender women and nonbinary people seeking feminizing therapy are often prescribed estrogen as a gender-affirming hormone, which will alter their reproductive hormone axis. Testosterone, estradiol, and other reproductive hormones are commonly evaluated to assess therapy, but reference intervals specific to transgender women have not been established. The objective of this study was to derive reference intervals for commonly measured analytes related to reproductive endocrinology in a cohort of healthy gender nonconforming individuals on stable feminizing hormone therapy. Methods Healthy transgender individuals who had been prescribed estrogen (n = 93) for at least a year were recruited from internal medicine and primary care clinics that specialize in transgender medical care. Total testosterone and estradiol were measured using immunoassay and mass spectrometry; LH, FSH, sex hormone binding globulin, prolactin, progesterone, anti-mullerian hormone (AMH), and dehydroepiandrosterone sulfate (DHEAS) were measured using immunoassay; free testosterone was calculated. Reference intervals (central 95%) were calculated according to Clinical Laboratory Standards Institute guidelines. Results The distribution of results for transgender women was different than what would be expected from cisgender men or women across all measurements. Use of spironolactone was associated with changes in the result distribution of AMH, FSH, LH, and progesterone. Compared to liquid chromatography coupled to tandem mass spectrometry (LC/MS/MS), immunoassay was sufficient for the majority of estradiol and total testosterone measurements; free testosterone added little clinical value beyond total testosterone. Conclusion Reference intervals specific to transgender women should be applied when evaluating reproductive endocrine analytes. Spironolactone is a significant variable for result interpretation of some tests.

scholarly journals Hyperandrogenism by Liquid Chromatography Tandem Mass Spectrometry in PCOS: Focus on Testosterone and Androstenedione

2020 ◽  
Vol 10 (1) ◽  
pp. 119
Author(s):  
Giorgia Grassi ◽  
Elisa Polledri ◽  
Silvia Fustinoni ◽  
Iacopo Chiodini ◽  
Ferruccio Ceriotti ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
Polycystic Ovary ◽  
Free Testosterone ◽  
Reference Intervals ◽  
Model Assessment ◽  
Homeostatic Model Assessment ◽  
Liquid Chromatography Tandem Mass ◽  
And Control ◽  
The Impact

The identification of hyperandrogenism in polycystic ovary syndrome (PCOS) is concerning because of the poor accuracy of the androgen immunoassays (IA) and controversies regarding which androgens should be measured. The aim of our study was to evaluate the impact of the assessment of testosterone (T) and androstenedione (A) by liquid chromatography in tandem with mass spectrometry (LC/MS-MS), in the diagnosis of PCOS. We evaluated 131 patients referred for suspected PCOS. Fourteen patients in total were excluded, some because of other diagnosis (n = 7) or incomplete diagnostic workup (n = 7). We measured T and A both by IA and LC-MS/MS in the 117 subjects included. We calculated free T (fT) by the Vermeulen formula and recorded clinical and metabolic data. 73 healthy females served as controls to derive immunoassays (IA) and LC-MS/MS reference intervals for T, fT and A. PCOS was confirmed in 90 subjects by IA and in 93 (+3.3%) by LC-MS/MS. The prevalence of biochemical hyperandrogenism in PCOS by LC-MS/MS increased from 81.7% to 89.2% if A was also considered. The most frequently elevated androgens were fT (73.1%) and A (64.5%) and they had similar levels of accuracy in differentiating PCOS and controls (0.34 ng/dL, Sn 91% Sp 89%; 1.16 ng/mL, Sn 91% Sp 88%, respectively). Free testosterone correlated with body mass index (BMI), homeostatic model assessment (HOMA)-index, glycated hemoglobin (HbA1c), and sex-binding globulin (SHBG). The results confirm that LC-MS/MS is slightly more sensitive than IA in the diagnosis of PCOS with LC-MS/MS detecting higher levels of fT and A. Moreover, assessment of fT and A by LC-MS/MS had a similar level of accuracy in discriminating between PCOs and control subjects. Lastly, fT by LC-MS/MS correlates with adverse metabolic parameters.

scholarly journals Comparing Ethnicity-Specific Reference Intervals for Clinical Laboratory Tests from EHR Data

2018 ◽  
Vol 3 (3) ◽  
pp. 366-377 ◽  
Author(s):  
Nadav Rappoport ◽  
Hyojung Paik ◽  
Boris Oskotsky ◽  
Ruth Tor ◽  
Elad Ziv ◽  
...  
Keyword(s):  
Race And Ethnicity ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Local Population ◽  
Reference Intervals ◽  
Medical Decision ◽  
Specific Reference ◽  
Healthy Individuals ◽  
Electronic Health Record Data ◽  
Novel Approach

Abstract Background The results of clinical laboratory tests are an essential component of medical decision-making. To guide interpretation, test results are returned with reference intervals defined by the range in which the central 95% of values occur in healthy individuals. Clinical laboratories often set their own reference intervals to accommodate variation in local population and instrumentation. For some tests, reference intervals change as a function of sex, age, and self-identified race and ethnicity. Methods In this work, we develop a novel approach, which leverages electronic health record data, to identify healthy individuals and tests for differences in laboratory test values between populations. Results We found that the distributions of >50% of laboratory tests with currently fixed reference intervals differ among self-identified racial and ethnic groups (SIREs) in healthy individuals. Conclusions Our results confirm the known SIRE-specific differences in creatinine and suggest that more research needs to be done to determine the clinical implications of using one-size-fits-all reference intervals for other tests with SIRE-specific distributions.

scholarly journals Polycystic ovary syndrome: clinical and laboratory evaluation

1996 ◽  
Vol 114 (4) ◽  
pp. 1222-1225 ◽  
Author(s):  
Marcos Yorghi Khoury ◽  
Edmund Chada Baracat ◽  
Dolores Perovano Pardini ◽  
Mauro Abi Haidar ◽  
Eduardo Leme Alves da Motta ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Laboratory Tests ◽  
Late Onset ◽  
Polycystic Ovary ◽  
Free Testosterone ◽  
Dehydroepiandrosterone Sulfate ◽  
Laboratory Evaluation ◽  
Clinical Feature ◽  
Age At Menarche ◽  
Ovary Syndrome

OBJECTIVE: To evaluate clinically, and with laboratory, tests, women with polycystic ovary syndrome (PCO). PATIENTS: One hundred and twelve women with PCO were studied. METHODS: The following data was recorded: Current age; age at menarche; menstrual irregularity, occurrence of similar cases in the family; fertility, obstetric history; body mass index (BMI); and presence of hirsutism. Serum measurements of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, free testosterone, and dehydroepiandrosterone sulfate were taken. RESULTS: All patients presented either oligomenorrhea (31 percent), periods of secondary amenorrhea (9 percent), or both alterations (60 percent). The majority of the patients were infertile (75.6 percent). The LH/FSH ratio was higher than 2:1 in 55 percent of the patients and higher than 3:1 in 26.2 percent. The ultrasonographic aspect of the ovaries was considered to be normal in 31 percent. CONCLUSION: The main clinical feature of the PCO is the irregularity of menses since menarche, and that the laboratory tests would be important to exclude other disorders such as hyperprolactinemia or hyperandrogenemia caused by late-onset congenital adrenal hyperplasia.

scholarly journals Collaborative derivation of reference intervals for major clinical laboratory tests in Japan

2016 ◽  
Vol 53 (3) ◽  
pp. 347-356 ◽  
Author(s):  
Kiyoshi Ichihara ◽  
Yoshikazu Yomamoto ◽  
Taeko Hotta ◽  
Shigemi Hosogaya ◽  
Hayato Miyachi ◽  
...  
Keyword(s):  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Reference Intervals

scholarly journals Reference Intervals of Total Testosterone in Adult Filipino Men

2020 ◽  
Vol 2020 ◽  
pp. 1-5
Author(s):  
Myrna Buenaluz‐Sedurante ◽  
Mark Isaiah K. Co ◽  
Daryl Jade T. Dagang ◽  
Racquel G. Bruno ◽  
Annie Jane N. Sarmiento ◽  
...  
Keyword(s):  
Young Adult ◽  
Reference Range ◽  
Clinical History ◽  
Free Testosterone ◽  
Reference Intervals ◽  
The Philippines ◽  
Sex Hormone Binding Globulin ◽  
Total Testosterone ◽  
Reference Ranges ◽  
Healthy Young Adult

Background. The reference range of total testosterone needs to be established locally as ethnic differences in adiposity, insulin sensitivity, and sex hormone-binding globulin (SHBG) levels may affect total testosterone levels. The aim of this study is to establish the reference intervals of total testosterone from healthy, young adult Filipino males. Methods. The study included 110 healthy, Filipino male volunteers aged 21–40, studying or working at the University of the Philippines Manila. Clinical history, height, weight, body mass index (BMI), and blood pressure (BP) were obtained, and blood for total testosterone, SHBG, albumin, insulin, fasting blood sugar (FBS), and total cholesterol was collected. Free testosterone was calculated using Vermeulen’s formula. The 2.5th to 97.5th percentiles of subjects for total testosterone were used as the normative range for Filipino men. Results. The reference range of total testosterone is 7.33–53.01 nmol/L. Conclusion. The present study derived reference ranges of total testosterone using data from apparently healthy, young adult men to support clinical services.

scholarly journals Pathogenesis, clinical manifestation, diagnosis of hypergonadotropic hypogonadism in women of reproductive age with hyporandrogenia.

2018 ◽  
Vol 95 (12) ◽  
pp. 1101-1105
Author(s):  
Natavan E. Akhundova ◽  
E. M. Aliyeva ◽  
R. M. Mamedgasanov
Keyword(s):  
Free Testosterone ◽  
Dehydroepiandrosterone Sulfate ◽  
Reproductive Period ◽  
Reproductive Age ◽  
Blood Levels ◽  
Total Testosterone ◽  
Hypergonadotropic Hypogonadism ◽  
Significant Elevation ◽  
Women Of Reproductive Age ◽  
Spontaneous Pregnancy

Aim. To explore clinical diagnostical criteria of hypergonadotropic hypogonadism in patients with hyperandrogenia in reproductive period. Material and methods. 21 women with hyperandrogenia and hypergonadotropic hypogonadism were examined (basic qroup). Comperative qroup was presented by 20 practically healthy women of reproductive age. The following indicators were investigated family history, the severity of hirsutism, blood levels of folliculostimulating (FSH), luteinized (LH), thyroid stimulating (TSH) hormons, the ratio of LH/FSH, prolactin, cortizol, 17-oxyprogesterone (17-OP), dehydroepiandrosterone sulfate (DHEA-S), androstentione, total testosterone, free triyoitironin (T2), thyroxine (T4), estrone (E1), estradiol (E2), sex hormone binding globuline (SHBG), antimullerian hormone (AMH). Results. There was confirmed that patients of reproductive age with hypergonadotropic hypogonadism with hyperandrogenia have significant elevation of FSH, LH, E1, An, K, 17-OP, DHEA-S, free testosterone leveles, and decreasing of E2, SHBG and AMH livels. Timely diagnosis of hypergonadotropic hypogonadism significantly reduces the risk of premature ovarian failure, and increases probability of spontaneous pregnancy.

scholarly journals Correlation of Hyperandrogenemia and Metabolic Syndrome in Thai Women With Polycystic Ovary Syndrome (PCOS).

2021 ◽  
Author(s):  
Suchada Indhavivadhana ◽  
Matinuch Kuichanuan ◽  
Thanyarat Wongwananuruk ◽  
Kitirat Techatraisak ◽  
Panicha Chantrapanichkul ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
National Cholesterol Education Program ◽  
Polycystic Ovary ◽  
Free Testosterone ◽  
Dehydroepiandrosterone Sulfate ◽  
Total Testosterone ◽  
Adult Treatment Panel ◽  
Ovary Syndrome ◽  
Thai Women ◽  
Blood Data

Abstract Objective: To investigate the prevalence of metabolic syndrome compared between hyperandrogenemia and non-hyperandrogenemia in Thai women with PCOS, and to identify factors significantly associated with metabolic syndrome in this PCOS population.Methods: Thai PCOS women were conducted during 2010-2018. Patients were categorized into the non-hyperandrogenemia group or the hyperandrogenemia group defined by total testosterone >0.8 ng/mL or free testosterone >0.006 ng/mL or dehydroepiandrosterone sulfate (DHEA-S) >350 mcg/dL. Metabolic syndrome was diagnosed according to National Cholesterol Education Program-Adult Treatment Panel III criteria. Demographic, anthropometric, clinical, and biochemical blood data were collected and analyzed.Results: 520 PCOS women were included. 22.6% had metabolic syndrome and 75.0% had hyperandrogenemia. Free testosterone cut-off to define hyperandrogenemia for determining metabolic syndrome in PCOS yielded the highest sensitivity (88.9%) and the highest negative predictive value (90.8%). The prevalence of metabolic syndrome was 27.1% in hyperandrogenemia and 9.2% in non-hyperandrogenemia. Factors significantly associating with metabolic syndrome in Thai PCOS women were age, BMI, free testosterone, and DHEA-S.Conclusion: The prevalence of metabolic syndrome was to be significantly higher in hyperandrogenemia women than in their non-hyperandrogenemia counterparts. Older age, higher BMI, higher free testosterone, and lower DHEA-S were all identified as factors significantly associated with metabolic syndrome.

scholarly journals MANAGEMENT OF ENDOCRINE DISEASE Hyperandrogenic states in women: pitfalls in laboratory diagnosis

2018 ◽  
Vol 178 (4) ◽  
pp. R141-R154 ◽  
Author(s):  
Michel Pugeat ◽  
Ingrid Plotton ◽  
Aude Brac de la Perrière ◽  
Gérald Raverot ◽  
Henri Déchaud ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Limit Of Detection ◽  
High Specificity ◽  
Free Testosterone ◽  
Laboratory Diagnosis ◽  
Sex Hormone Binding Globulin ◽  
Total Testosterone ◽  
Adrenal Androgen ◽  
Androgen Excess ◽  
Specificity And Sensitivity

Measuring total testosterone level is the first-line approach in assessing androgen excess in women. The main pitfalls in measuring testosterone relate to its low concentration and to the structural similarity between circulating androgens and testosterone, requiring accurate techniques with high specificity and sensitivity. These goals can be achieved by immunoassay using a specific anti-testosterone monoclonal antibody, ideally after an extraction step. Liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS) will be commonly used for measuring testosterone, providing optimal accuracy with a low limit of detection. Yet, the pitfalls of these two techniques are well identified and must be recognized and systematically addressed. In general, laboratories using direct testosterone immunoassay and mass spectrometry need to operate within a quality framework and be actively engaged in external quality control processes and standardization, so as to ensure appropriate interpretation irrespective of the particular laboratory. Circulating testosterone is strongly bound to sex-hormone-binding globulin (SHBG), and SHBG levels are typically low in overweight hyperandrogenic patients. Thus, low SHBG may decrease circulating testosterone to normal values, which will mask androgen excess status. One way to avoid this pitfall, awaiting direct free testosterone assays that are yet to be developed, is to measure SHBG and calculate free testosterone. A few other pitfalls will be discussed in this review, including those of adrenal androgen exploration, with the aim of helping clinicians to better handle laboratory investigation of androgen excess disorders in women.

scholarly journals Testosterone or Dehydroepiandrosterone Sulfate as a Biomarker for Hirsutism in Women with Polycystic Ovary Syndrome

2020 ◽  
Vol 13 (4) ◽  
pp. 1815-1823
Author(s):  
Husam Jihad Imran ◽  
Samer Abdulameer Dhaher ◽  
Abbas Ali Mansour
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Free Testosterone ◽  
Dehydroepiandrosterone Sulfate ◽  
Medical Problem ◽  
Total Testosterone ◽  
Ovary Syndrome ◽  
Healthy Control ◽  
Control Study ◽  
Rotterdam Criteria

Background:Hirsutism is a distressing medical problem for women. Most of hirsutism in women is associated with excess androgen, and most cases have PCOS as an underlying cause.Which androgen to be used to evaluate clinical or biochemical hyperandrogenism in women with PCOS is still debated.There are a small number of studies that evaluated androgens in women with PCOS having hirsutism with conflicting results. The Objective of this study was to determine which androgen predict hirsutism in women with polycystic ovary syndrome (PCOS). Patients and Methods:A case-control study was done in Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah, Iraq. A total of 130 women with PCOS (based on Rotterdam criteria) and 70 healthy controls of comparable age (16-40 years) were investigated for androgens (total testosterone, free testosterone, DHEA-S) using Electrochemiluminescence technology assay; excess hair was examined according to the modified Ferriman-Gallwey (mFG) score and a cut-off value of 8 defined hirsutism. Results: In the three groups of women, the first (n=100) included PCOS with hirsutism, the second (n=30) PCOS without hirsutism, and the third (n=70) women without PCOS or hirsutism as healthy control, hirsutism was seen in about 77 % of PCOS women mostly of moderate severity; High TT, FT, DHEA-S, and overall androgens were seen in 69%, 76%, 37%, and 99% respectively of our PCOS women with hirsutism. No correlation was found between TT, FT, and DHEA-S and the mFG score. Conclusions: This study provides evidence that presence of hirsutism in women with PCOS was associated with a higher level of biochemical hyperandrogenism than seen in PCOS without hirsutism; however, there was no correlation between the studied androgens and mFG score.

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