Background Women with polycystic ovarian syndrome have a high prevalence of metabolic syndrome and type 2 diabetes mellitus. Blacks and Hispanics have a high morbidity and mortality due to cardiovascular disease and diabetes mellitus in the general population. Since metabolic syndrome is a risk factor for development of type 2 diabetes and cardiovascular disease, understanding any racial and ethnic differences in metabolic syndrome amongst women with polycystic ovarian syndrome is important for prevention strategies. However, data regarding racial/ethnic differences in metabolic phenotype amongst women with polycystic ovary syndrome is inconsistent. Objective To determine if there are racial/ethnic differences in insulin resistance, metabolic syndrome and hyperandrogenemia in women with polycystic ovarian syndrome. Study Design Secondary data analysis of a prospective multicenter, double blind controlled clinical trial, the Pregnancy in Polycystic Ovary Syndrome II study, conducted in 11 academic health centers. Data on 702 women with polycystic ovarian syndrome aged 18-40 years who met modified Rotterdam criteria for the syndrome and wished to conceive were included in the study. Women were grouped into racial/ethnic categories Non-Hispanic Whites, non-Hispanic Blacks and Hispanic. The main outcomes were the prevalence of insulin resistance, metabolic syndrome and hyperandrogenemia in the different racial/ethnic groups. Results BMI (35.1 ± 9.8 vs. 35.7 ± 7.9 vs. 36.4 ± 7.9 kg/m2) and waist circumference (106.5 ± 21.6 vs. 104.9 ± 16.4 vs. 108.7 ± 7.3 cm) did not differ significantly between non-Hispanic White, non-Hispanic Black and Hispanic women. Hispanic women with PCOS had a significantly higher prevalence of hirsutism (93.8 vs. 86.8%), abnormal free androgen index (FAI) (75.8 vs. 56.5%), abnormal homeostasis model assessment (HOMA) (52.3 vs. 38.4%) and hyperglycemia (14.8 vs. 6.5%), as well as lower sex hormone binding globulin compared to non-Hispanic Whites. Non-Hispanic Black women had a significantly lower prevalence of metabolic syndrome (24.5 vs. 42.2%) compared with Hispanic women, and lower serum triglyceride levels compared to both Hispanics and non-Hispanic Whites (85.7 ± 37.3 vs. 130.2 ± 57.0 vs. 120.1 ± 60.5 vs. mg/dL, p<0.01), with a markedly lower prevalence of hypertriglyceridemia (5.1 vs. 28.3 vs. 30.5%, p<0.01) compared to the other two groups. Comment Hispanic women with PCOS have the most severe phenotype, both in terms of hyperandrogenism and metabolic criteria. Non-Hispanic Black women have an overall milder polycystic ovarian syndrome phenotype than Hispanics and in some respects, than Non-Hispanic White women.

NCT00719186 and NCT01044862.

Objective To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Design Randomized, prospective clinical trial Patients 900 couples with unexplained infertility Interventions: Ovarian stimulation with gonadotropins, clomiphene citrate, or letrozole in conjunction with intrauterine insemination. Setting Multicenter University based clinical practices. Main Outcome Measures Demographic, laboratory, imaging, and survey characteristics. Interventions Collection of baseline demographics, blood samples, and ultrasonographic assessments. Results Demographic characteristics of women receiving clomiphene citrate, letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7± 25.7 months, with 59% primary infertility. More than 1/3 of the women were current or past smokers. The mean BMI was 27 and mean AMH level was 2.6; only 11 women (1.3%) had antral follicle counts of less than 5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. Conclusion The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, AMH levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment subgroups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and clomiphene citrate treatment.

Introduction Newly available, smartphone-enabled carbon monoxide (CO) monitors are lower in cost than traditional stand-alone monitors and represent a marked advancement for smoking research. New products are promising, but data are needed to compare breath CO readings between smartphone-enabled and stand-alone monitors. The purpose of this study was to: 1) determine agreement between the mobile iCO TM (Bedfont ® Scientific Ltd.) with two other monitors from the same manufacturer (Micro +TM pro and Micro +TM basic), and 2) determine optimal, monitor-specific, cotinine-confirmed abstinence cut-off values. Methods Adult (≥18) smokers (n=26) and non-smokers (n=21) provided three breath CO samples (using three different monitors) in each of 10 sessions and urine cotinine was measured for gold standard determination of abstinence. CO comparisons (N=437) were analyzed using regression-based Bland-Altman Analysis of Agreement; receiver operating characteristics curves were used to determine optimal abstinence cut-offs. Results Bland-Altman analyses indicated that the iCO TM monitor provided higher CO results than both Micro +TM monitors. Sensitivity and specificity analyses showed that the optimal CO cut-off for determining abstinence was &lt;3 ppm for the Micro +TM pro (88% sensitivity, 93% specificity) and Micro +TM basic (83% sensitivity, 98% specificity), but was higher for the iCO TM (&lt;6 ppm; 73% sensitivity, 100% specificity). Conclusions Relative to both Micro +TM monitors, the smartphone-enabled iCO TM provided systematically higher CO values and required a higher cut-off to reliably determine smoking abstinence. This does not indicate that CO values obtained using the iCO TM are not valid, instead these results suggest that monitor-specific abstinence cut-offs are needed to ensure accurate bioverification of smoking status. Implications Results from this study indicate that CO values from the smartphone-enabled iCO TM should not be used interchangeably with the stand-alone Micro +TM pro and Micro +TM basic, particularly when lower CO values (&lt;10 ppm) are critical (i.e., determination of abstinence vs. confirming smoking status for study inclusion). Optimal CO cut-offs for determining abstinence on both Micro +TM monitors is recommended at &lt;3 ppm, and &lt;6 ppm for the iCO TM.

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