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Objective: To determine the feasibility, safety, and outcomes of an oil-based, iodinated contrast using office-based, ultrasound-imaged hysterosalpingography in women with infertility., Design: Randomized Controlled Double Blind Clinical Trial., Setting: Academic health center., Interventions: Tubal flushing with oil-based contrast medium (Lipiodol UF) versus saline., Main Outcome Measures: Ongoing pregnancy rate, pain, quality of life, and thyroid function., Results: Forty-eight patients (24 in each group) were analyzed. The groups were well-matched at baseline. Ongoing pregnancy was noted in 17% (4/24) of the oil-contrast group versus 37% (9/24) in the saline group. Saline group patients more frequently initiated infertility therapy in the six-month follow-up period (saline, 67% vs. oil, 33%), and no serious adverse events in either group. There were no differences in pain from the procedure between groups. There were no differences in thyroid function tests postprocedure between groups, but within the oil-contrast group, there was a slight increase in thyroid-stimulating hormone (post vs. preratio of geometric means: 1.18; 95% confidence interval [CI], 1.02-1.38) and decrease in Free T4 (postdifference vs. predifference in means: 0.08 ng/dL; 95% CI, -0.14 to -0.01). Immediately after the test, the physicians correctly guessed 79% of oil and 71% of saline randomization assignments, whereas patients correctly guessed 63% of oil and 38% of saline., Conclusions: This pilot study demonstrates the safety and feasibility of giving an oil-based contrast medium during ultrasound-imaged hysterosalpingography. Pregnancies were seen after oil-based administration, and this contrast is associated with minor thyroid function impairment., (© 2022 Published by Elsevier Inc. on behalf of American Society for Reproductive Medicine.)

Objective: To describe the prevalence of female sexual dysfunction in a well-defined polycystic ovary syndrome (PCOS) population, and to assess the impact of common PCOS treatments on sexual function., Design: Secondary analysis of a randomized controlled trial, oral contraceptive pills and weight loss in PCOS., Setting: Two academic medical centers., Patients: Women with PCOS (N = 114) defined by the Rotterdam criteria., Interventions: Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks., Main Outcome Measures: Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores after 16 weeks., Results: There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period. Overall, 33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55). Among this group, FSFI score improved after 16 weeks of Lifestyle and Combined treatments. There was no change in prevalence of sexual dysfunction in treatment groups at 16 weeks. Use of OCPs did not alter FSFI scores., Conclusion(s): Female sexual dysfunction is highly prevalent among women with PCOS. Our findings suggest that common treatments for PCOS, including intensive lifestyle modification and the combination of intensive lifestyle modification and OCPs, have the potential to improve sexual function in these women; the mechanism for these improvements is likely multifactorial., Clinical Trial Registration Number: NCT00704912., (Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To examine the effects of common treatments for polycystic ovary syndrome (PCOS) on a panel of hormones (reproductive/metabolic)., Design: Secondary analysis of blood from a randomized controlled trial of three 16-week preconception interventions designed to improve PCOS-related abnormalities: continuous oral contraceptive pills (OCPs, N = 34 subjects), intensive lifestyle modification (Lifestyle, N = 31), or a combination of both (Combined, N = 29)., Materials and Methods: Post-treatment levels of activin A and B, inhibin B, and follistatin (FST), as well as Insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 2 (IGFBP-2), glucagon, glucagon-like peptide 1 (GLP-1) and 2, and oxyntomodulin were compared to baseline, and the change from baseline in these parameters were correlated with outcomes., Results: Oral contraceptive pill use was associated with a significant suppression in activin A, inhibin A, and anti-mullerian hormone (AMH), but a significant increase in FST. IGF-1, IGFBP-2, glucagon, and GLP-2 levels were significantly decreased. Oxyntomodulin was profoundly suppressed by OCPs (ratio of geometric means: 0.09, 95% confidence interval [CI]: 0.05, 0.18, P < 0.001). None of the analytes were significantly affected by Lifestyle, whereas the effects of Combined were similar to OCPs alone, although attenuated. Oxyntomodulin was significantly positively associated with the change in total ovarian volume (rs = 0.27; 95% CI: 0.03, 0.48; P = 0.03) and insulin sensitivity index (rs = 0.48; 95% CI: 0.27, 0.64; P < 0.001), and it was inversely correlated with change in area under the curve (AUC) glucose [rs = -0.38; 95% CI: -0.57, -0.16; P = 0.001]. None of the hormonal changes were associated with live birth, only Activin A was associated with ovulation (risk ratio per 1 ng/mL increase in change in Activin A: 6.0 [2.2, 16.2]; P < 0.001)., Conclusions: In women with PCOS, OCPs (and not Lifestyle) affect a wide variety of reproductive/metabolic hormones, but their treatment response does not correlate with live birth., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: To study the development of children conceived from non-IVF infertility treatments consisting of gonadotropins, clomiphene, or letrozole., Design: Prospective cohort study., Setting: U.S. academic health centers., Patient(s): Children of women with polycystic ovary syndrome who conceived with letrozole (LTZ) or clomiphene (CC) in the PPCOS II study or women with unexplained infertility (AMIGOS study) who conceived with LTZ, CC, or gonadotropin (GN)., Intervention(s): Longitudinal annual follow-up from birth to age 3., Main Outcome Measure(s): Scores from Ages and Stages Developmental Questionnaire (ASQ), MacArthur-Bates Communicative Development Inventory (MCDI), and annual growth., Result(s): One hundred eighty-five children from 160 families participated in at least one follow-up evaluation from the two infertility trials. Most multiple gestations in the follow-up study resulted from GN treatment (n = 14) followed by CC (n = 6) and LTZ (n = 3). There were no significant differences among the three groups at any time point with respect to abnormal scores on the ASQ. On the MCDI Words and Gestures, the LTZ group scored significantly higher than the GN group for most items (phrases, early gestures, later gestures, and total gestures). Children in the CC group scored significantly higher than the GN group for the later gestures and total gestures items., Conclusion(s): Differences in growth and cognitive developmental rates among children conceived with first-line infertility therapies, including LTZ, are relatively minor and likely due to differences in multiple pregnancy rates., (Copyright © 2020. Published by Elsevier Inc.)

Context: Women with polycystic ovary syndrome (PCOS) have increased risk for pregnancy complications, possibly related to pre-existing obesity and excessive gestational weight gain (GWG)., Objectives: To assess the contributions of diagnosis and preconception weight on GWG and perinatal outcomes., Research Design and Methods: Prospective cohort study of singleton pregnancies in PCOS (n = 164) and ovulatory controls (n = 176) from infertility treatment., Main Outcome Measures: GWG, birthweight, pregnancy complications., Results: From preconception baseline, normal-weight women with PCOS gained 2.3 pounds more during the first trimester (95% CI, 0.3 to 4.3; P = 0.02), and by the end of the second trimester, 4.2 pounds more than controls (95% CI, 0.7 to 7.7; P = 0.02). Women who were overweight with PCOS gained significantly more weight than did controls by the end of the second trimester (5.2 pounds; 95% CI, 0.2 to 10.2; P = 0.04), whereas women with obesity and PCOS and control women had similar weight gain throughout pregnancy. Within normal-weight, overweight, and obese groups, prevalence of pre-eclampsia and gestational diabetes did not differ between the PCOS and control groups, nor was there a difference in birthweight. Preconception body mass index (BMI) was significantly associated with GWG; for every 1-kg/m2 increase in preconception BMI, GWG decreased by 0.62 pounds (95% CI, -0.85 to -0.40; P < 0.001)., Conclusions: Women with PCOS who are of normal weight or are overweight before conception experience more GWG than do ovulatory controls. Within normal-weight, overweight, and obese groups, rates of perinatal complications do not significantly differ between women with PCOS and controls. Preconception BMI is the strongest predictor of GWG.

Context: Daughters of women with polycystic ovary syndrome (PCOS) are thought to be at increased risk for developing stigmata of the syndrome, but the ontogeny during puberty is uncertain., Objective: We phenotyped daughters (n = 76) of mothers with PCOS and daughters (n = 80) from control mothers for reproductive and metabolic parameters characteristic of PCOS., Design, Setting, and Participants: We performed a matched case/control study at Penn State Hershey Medical Center that included non-Hispanic, white girls 4 to 17 years old., Intervention: We obtained birth history, biometric, ovarian ultrasounds, whole-body dual-energy X-ray absorptiometry scan for body composition, 2-hour glucose challenged salivary insulin levels, and two timed urinary collections (12 hours overnight and 3 hours in the morning) for gonadotropins and sex steroids., Main Outcome Measures: We measured integrated urinary levels of adrenal (dehydroepiandrosterone sulfate) and ovarian [testosterone (TT)] steroids. Other endpoints included integrated salivary insulin levels and urinary luteinizing hormone levels., Results: There were no differences in detection rates or mean levels for gonadotropins and sex steroids in timed urinary collections between PCOS daughters and control daughters, nor were there differences in integrated salivary insulin levels. Results showed that 69% of Tanner 4/5 PCOS daughters vs 31% of control daughters had hirsutism defined as a Ferriman-Gallwey score >8 (P = 0.04). There were no differences in body composition as determined by dual-energy X-ray absorptiometry between groups in the three major body contents (i.e., bone, lean body mass, and fat) or in ovarian volume between groups., Conclusions: Matched for pubertal stage, PCOS daughters have similar levels of urinary androgens and gonadotropins as well as glucose-challenged salivary insulin levels., (Copyright © 2017 by the Endocrine Society)

Context: In overweight/obese women with polycystic ovary syndrome (PCOS), the relative benefit of delaying infertility treatment to lose weight vs seeking immediate treatment is unknown., Objective: We compared the results of two, multicenter, concurrent clinical trials treating infertility in women with PCOS., Design, Setting, and Participants: This was a secondary analysis of two randomized trials conducted at academic health centers studying women 18-40 years of age who were overweight/obese and infertile with PCOS., Intervention: We compared immediate treatment with clomiphene from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial (N = 187) to delayed treatment with clomiphene after preconception treatment with continuous oral contraceptives, lifestyle modification (Lifestyle: including caloric restriction, antiobesity medication, behavioral modification, and exercise) or the combination of both (combined) from the Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (OWL PCOS) trial (N = 142)., Main Outcome Measures: Live birth, pregnancy loss, and ovulation were measured., Results: In PPCOS II, after four cycles of clomiphene, the cumulative per-cycle ovulation rate was 44.7% (277/619) and the cumulative live birth rate was 10.2% (19/187), nearly identical to that after oral contraceptive pretreatment in the OWL PCOS trial (ovulation 45% [67/149] and live birth: 8.5% [4/47]). In comparison, deferred clomiphene treatment preceded by lifestyle and combined treatment in OWL PCOS offered a significantly better cumulative ovulation rate compared to immediate treatment with clomiphene. (Lifestyle: 62.0% [80/129]; risk ratio compared to PPCOS II = 1.4; 95% confidence interval [CI], 1.1-1.7; P = .003; combined: 64.3% [83/129]; risk ratio compared to PPCOS II = 1.4; 95% CI, 1.2-1.8; P < .001 and a significantly better live birth rate lifestyle: 25.0% [12/48]; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3-4.7; P = .01 and combined: 25.5% [12/47]; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3-4.8; P = .01)., Conclusions: These data show the benefit of improved ovulation and live birth with delayed infertility treatment with clomiphene citrate when preceded by lifestyle modification with weight loss compared with immediate treatment. Pretreatment with oral contraceptives likely has little effect on the ovulation and live birth rate compared with immediate treatment.

Objectives: To assess whether a journal club model could improve comprehension and written and spoken medical English in a population of Chinese medical professionals., Setting and Participants: The study population consisted of 52 medical professionals who were residents or postgraduate master or PhD students in the Department of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine, China., Intervention: After a three-part baseline examination to assess medical English comprehension, participants were randomised to either (1) an intensive journal club treatment arm or (2) a self-study group. At the conclusion of the 8-week intervention participants (n=52) were re-tested with new questions., Outcome Measures: The primary outcome was the change in score on a multiple choice examination. Secondary outcomes included change in scores on written and oral examinations which were modelled on the Test of English as a Foreign Language (TOEFL)., Results: Both groups had improved scores on the multiple choice examination without a statistically significant difference between them (90% power). However, there was a statistically significant difference between the groups in mean improvement in scores for both written (95% CI 1.1 to 5.0; p=0.003) and spoken English (95% CI 0.06 to 3.7; p=0.04) favouring the journal club intervention., Conclusions: Interacting with colleagues and an English-speaking facilitator in a journal club improved both written and spoken medical English in Chinese medical professionals. Journal clubs may be suitable for use as a self-sustainable teaching model to improve fluency in medical English in foreign medical professionals., Trial Registration Number: NCT01844609., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Context: Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit., Objective: This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS., Design, Setting, and Participants: This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2)., Intervention: Women were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) ("OCP"); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss ("Lifestyle"); or 3) combined treatment with both OCP and lifestyle modification ("Combined"). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery., Main Outcome Measures: Weight, ovulation, and live birth were measured., Results: We consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, -6.2%; 95% confidence interval (CI), -7.4--5.0; and Combined (mean weight loss, -6.4%; 95% CI, -7.6--5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42-4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63-2.19) or Combined (OR, 0.72; 95% CI, 0.44-1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P < .05). Live birth rates were OCP, 12%; Lifestyle, 26%; and Combined, 24% (P = .13)., Conclusions: A preconception weight loss intervention eliminates the adverse metabolic oral contraceptive effects and, compared with oral contraceptive pretreatment, leads to higher ovulation rates.

Objective: To determine the effects of high-dose vitamin D on insulin sensitivity in polycystic ovary syndrome (PCOS)., Design: Randomized, placebo-controlled trial., Setting: Academic medical center., Patient(s): Twenty-eight women with PCOS., Intervention(s): Vitamin D3, 12,000 IU, or placebo daily for 12 weeks., Main Outcome Measure(s): The primary outcome was quantitative insulin sensitivity check index. Secondary outcomes included glucose and insulin levels during a 75-g oral glucose tolerance test and blood pressure., Result(s): Twenty-two women completed the study. Compared with placebo, vitamin D significantly increased 25-hydroxyvitamin D (mean [95% confidence interval] in vitamin D group 20.1 [15.7 to 24.5] ng/mL at baseline and 65.7 [52.3 to 79.2] ng/mL at 12 weeks; placebo 22.5 [18.1 to 26.8] ng/mL at baseline and 23.8 [10.4 to 37.2] ng/mL at 12 weeks). There were no significant differences in quantitative insulin sensitivity check index and other measures of insulin sensitivity; however, we observed trends toward lower 2-hour insulin and lower 2-hour glucose. We also observed a protective effect of vitamin D on blood pressure., Conclusion(s): In women with PCOS, insulin sensitivity was unchanged with high-dose vitamin D, but there was a trend toward decreased 2-hour insulin and a protective effect on blood pressure., Clinical Trial Registration Number: NCT00907153., (Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: The objective of this study is to examine the effect of pregnancy on final adult height in women whose first live birth occurred in adolescence (

Objective: To provide healthcare providers, patients, and the general public with a responsible assessment of currently available data on diagnosing gestational diabetes mellitus (GDM)., Participants: A non-U.S. Department of Health and Human Services, nonadvocate 15-member panel representing the fields of obstetrics and gynecology, maternal-fetal medicine, pediatrics, diabetic research, biostatistics, women's health issues, health services research, decision analysis, health management and policy, health economics, epidemiology, and community engagement. In addition, 16 experts from pertinent fields presented data to the panel and conference audience., Evidence: Presentations by experts and a systematic review of the literature prepared by the University of Alberta Evidence-based Practice Centre, through the Agency for Healthcare Research and Quality (AHRQ). Scientific evidence was given precedence over anecdotal experience., Conference Process: The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was posted at http://prevention.nih.gov/ for public comment and the panel released a final statement approximately 10 weeks later. The final statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government., Conclusions: At present, GDM is commonly diagnosed in the United States using a 1-hour screening test with a 50-gram glucose load followed by a 3-hour 100-gram glucose tolerance test (a two-step approach) for those found to be abnormal on the screen. This approach identifies approximately 5% to 6% of the population as having GDM. In contrast, newly proposed diagnostic strategies rely on the administration of a 2-hour glucose tolerance test (a one-step approach) with a fasting component and a 75-gram glucose load. These strategies differ on whether a 1-hour sample is included, whether two abnormal values are required, and the diagnostic cutoffs that are used. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) has proposed diagnostic thresholds based on demonstrated associations between glycemic levels and an increased risk of obstetric and perinatal morbidities. The panel considered whether a one-step approach to the diagnosis of GDM should be adopted in place of the two-step approach. The one-step approach offers certain operational advantages. The current two-step approach is used only during pregnancy and is largely restricted to the United States. There would be value in a consistent, international diagnostic standard across one's lifespan. This unification would allow better standardization of best practices in patient care and comparability of research outcomes. The one-step approach also holds potential advantages for women and their health care providers, as it would allow a diagnosis to be achieved within the context of one visit as opposed to two. However, the one-step approach, as proposed by the IADPSG, is anticipated to increase the frequency of the diagnosis of GDM by twofold to threefold, to a prevalence of approximately 15% to 20%. There are several concerns regarding the diagnosis of GDM in these additional women. It is not well understood whether the additional women identified by this approach will benefit from treatment, and if so, to what extent. Moreover, the care of these women will generate additional direct and indirect health care costs. There is also evidence that the labeling of these women may have unintended consequences, such as an increase in cesarean delivery and more intensive newborn assessments. In addition, increased patient costs, life disruptions, and psychosocial burdens have been identified. Available studies do not provide clear evidence that a one-step approach is cost-effective in comparison with the current two-step approach. After much deliberation, the panel believes that there are clear benefits to international standardization with regard to the one-step approach. Nevertheless, at present, the panel believes that there is not sufficient evidence to adopt a one-step approach. The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes. Thus, the panel recommends that the two-step approach be continued. However, given the potential benefits of a one-step approach, resolution of the uncertainties associated with its use would warrant revision of this conclusion.

Context: Reproductive function may improve after bariatric surgery, although the mechanisms and time-related changes are unclear., Objective: The objective of the study was to determine whether ovulation frequency/quality as well as associated reproductive parameters improve after Roux en Y gastric bypass surgery., Design: This was a prospective cohort study that enrolled female subjects from 2005 to 2008 with study visits at baseline and then 1, 3, 6, 12, and up to 24 months after surgery., Setting: The study was conducted at an academic health center., Patients: Twenty-nine obese, reproductive-aged women not using confounding medications participated in the study., Main Outcome Measures: The primary outcome was integrated levels of urinary progestin (pregnanediol 3-glururonide) from daily urinary collections at 12 months postoperatively. Secondary outcomes were changes in vaginal bleeding, other biometric, hormonal, ultrasound, dual-energy x-ray absorptiometry measures, and Female Sexual Function Index., Results: Ninety percent of patients with morbid obesity had ovulatory cycles at baseline, and the ovulatory frequency and luteal phase quality (based on integrated pregnanediol 3-glururonide levels) were not modified by bariatric surgery. The follicular phase was shorter postoperatively [6.5 d shorter at 3 months and 7.9-8.9 d shorter at 6-24 months (P < 0.01)]. Biochemical hyperandrogenism improved, largely due to an immediate postoperative increase in serum SHBG levels (P < 0.01), with no change in clinical hyperandrogenism (sebum production, acne, hirsutism). Bone density was preserved, contrasting with a significant loss of lean muscle mass and fat (P < 0.001), reflecting preferential abdominal fat loss (P < 0.001). Female sexual function improved 28% (P = 0.02) by 12 months., Conclusions: Ovulation persists despite morbid obesity and the changes from bypass surgery. Reproductive function after surgery is characterized by a shortened follicular phase and improved female sexual function.

Objective: To examine the contributions of obesity and race to levels of 25-hydroxyvitamin D [25(OH)D] and parathyroid hormone (PTH) in a defined cohort of black and white women., Methods: An interventional study was conducted from October 2004 to March 2008, among 219 healthy female volunteers. Serum 25(OH)D and PTH levels were determined in 117 African American women and 102 white women and the results were compared with body mass index (BMI), percentage body fat, serum lipids, and PTH levels., Results: Black women had lower median levels of 25(OH)D compared with white women (27.3 nmol/L vs 52.4 nmol/L; P<0.001). Serum levels of 25(OH)D below 50 nmol/L were found in 98% of black women and 45% of white women (P<0.001). The differences between the racial groups in the levels of 25(OH)D persisted despite adjustments for body weight, percentage body fat, and BMI. Black women had higher median serum levels of PTH than white women (31.9 pg/mL vs 22.3 pg/mL; P<0.01)., Conclusion: African American women are at significant risk for low vitamin D levels. Studies are needed to determine if low vitamin D status in young African American women is associated with a greater risk for vitamin D-related chronic diseases that can be reduced with vitamin D supplementation., (Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

We prospectively correlated the 24-hour ambulatory blood pressure measurements (ABPM) to conventional sphygmomanometer blood pressure measurements (CSM) in women at risk for gestational hypertensive disorders (GHTNDs) and identified predictive factors from ABPM for GHTND. We analyzed 73 women with ≥ 1 risk factor for developing a GHTND. Using both the CSM and ABPM, the systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP), and heart rate (HR) were measured for 24 hours during three periods (14 to 24 weeks; 24 to 32 weeks; and 33 weeks to delivery). Correlation between the CSM and ABPM lessened as pregnancy progressed. Seventeen (25%) of women developed a GHTND. MAP variability increased in the GHTND group versus those without a GHTND. The odds of developing a GHTND increased 1.5 times for every 1 beat per minute increase in the ABPM 24-hour HR at visit 1 and reversed by visit 3. In women at risk for a GHTND, CSM and ABPM correlate less well as pregnancy advances. HR changes in at-risk women may be a marker for the development of a GHTND and may reflect increased sympathetic activity and/or decreased baroreceptor sensitivity., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: To estimate racial disparities in the polycystic ovary syndrome (PCOS) phenotype between white and black women with PCOS., Design: Case-control study., Setting: Two academic medical centers., Patient(s): A total of 242 women not taking confounding medications in otherwise good health., Intervention(s): Phenotyping during the follicular phase or anovulation after an overnight fast in women., Main Outcome Measure(s): Biometric, serum hormones, glycemic and metabolic parameters, and body composition by dual-energy x-ray absorptiometry., Result(s): We studied 77 white and 43 black women with PCOS and 35 white and 87 black controls. Black women with PCOS were similar reproductively to white women with PCOS. Black women with PCOS had lower levels of serum transaminases, higher high-density lipoprotein cholesterol levels (mean difference [MD], 18.2 mg/dL; 95% confidence intervals [CI], 14.3, 22.1 mg/dL), lower triglyceride levels (MD, -43.2 mg/dL; 95% CI, -64.5, -21.9), and enhanced insulinogenic index on the oral glucose tolerance test compared with white women with PCOS. Black women with PCOS had higher bone mineral density (MD, 0.1 g/cm(2); 95% CI, 0.1, 0.2 g/cm(2)), lower percent body fat on dual-energy x-ray absorptiometry (MD, -2.8%; 95% CI, -5.1%, -0.5%), and overall a higher quality of life. Although most of these findings disappeared when the differences with racially matched controls were compared, black women with PCOS compared with black controls had lower estradiol levels than white women with PCOS compared with white controls (MD, -12.9 pg/mL; 95% CI, -24.9, -0.8 pg/mL), higher systolic blood pressure (MD, 9.1 mm Hg; 95% CI, 0.8, 17.4 mm Hg), and lower fasting glucose levels (MD, -12.0 mg/dL; 95% CI, -22.3, -1.7 mg/dL)., Conclusion(s): Racial disparities in PCOS phenotype are minor and mixed. Future studies should explore if race impacts treatment effects., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Our small study does not support the addition of metformin to the lifestyle of adolescents. Although there are favorable trends toward hyperandrogenism with metformin, these must be balanced against the increased rate of gastrointestinal side effects. However, other treatments were associated with an improved quality of life., (Copyright © 2011. Published by Elsevier Inc.)

Pregnancy outcomes and adverse outcomes in infertility trials are reported to varying extents; for example, 35% of clinical trials reported no information on pregnancy loss, only 43% reported adverse events during the preconception treatment period, and only 7% reported any serious adverse events. Incomplete reporting limits the value of these studies in counseling patients on the risk-benefit ratio of treatment to themselves and their infants., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To determine if the combination of lifestyle (caloric restriction and exercise) and metformin (MET) would be superior to lifestyle and placebo (PBO) in improving the polycystic ovary syndrome (PCOS) phenotype., Design: Double-blind randomized 6-month trial of MET versus PBO., Setting: Two academic medical centers., Patient(s): One hundred fourteen subjects with PCOS were randomized to MET (N = 55) or PBO (N = 59)., Intervention(s): Subjects collected urine daily for ovulation monitoring, had monthly monitoring of hormones and weight and determination of body composition by dual-energy x-ray absorptiometry, glucose tolerance, and were evaluated for quality of life at baseline and completion., Main Outcome Measure(s): Ovulation rates and testosterone levels., Result(s): Dropout rates were high. There was no significant difference in ovulation rates. Testosterone levels were significantly lower compared with baseline in the MET group at 3 mos but not at 6 mos. There were no differences in weight loss between groups, but MET showed a significant decline at 6 months compared with baseline (-3.4 kg, 95% confidence interval -5.3 to -1.5 kg). We noted divergent effects of MET versus PBO on oral glucose tolerance test indices of insulin sensitivity (increased) and secretion (worsened). Total bone mineral density increased significantly in MET. There were no differences in quality of life measures between the groups. The MET group had increased diarrhea and headache, but fewer bladder infections and musculoskeletal complaints., Conclusion(s): The addition of metformin to lifestyle therapy produced little reproductive or glycemic benefit in women with PCOS, although our study had limited power owing to a high dropout rate. It is not possible at baseline to identify women likely to drop out., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Air pollution has been associated with reproductive complications. We hypothesized that declining air quality during in vitro fertilization (IVF) would adversely affect live birth rates., Methods: Data from US Environmental Protection Agency air quality monitors and an established national-scale, log-normal kriging method were used to spatially estimate daily mean concentrations of criteria pollutants at addresses of 7403 females undergoing their first IVF cycle and at the their IVF labs from 2000 to 2007 in the Northeastern USA. These data were related to pregnancy outcomes., Results: Increases in nitrogen dioxide (NO(2)) concentration both at the patient's address and at the IVF lab were significantly associated with a lower chance of pregnancy and live birth during all phases of an IVF cycle from medication start to pregnancy test [most significantly after embryo transfer, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.66-0.86, per 0.01 ppm increase]. Increasing ozone (O(3)) concentration at the patient's address was significantly associated with an increased chance of live birth during ovulation induction (OR 1.26, 95% CI 1.10-1.44, per 0.02 ppm increase), but with decreased odds of live birth when exposed from embryo transfer to live birth (OR 0.62, 95% CI 0.48-0.81, per 0.02 ppm increase). After modeling for interactions of NO(2) and O(3) at the IVF lab, NO(2) remained negatively and significantly associated with live birth (OR 0.86, 95% CI 0.78-0.96), whereas O(3) was non-significant. Fine particulate matter (PM(2.5)) at the IVF lab during embryo culture was associated with decreased conception rates (OR 0.90, 95% CI 0.82-0.99, per 8 microg/m(3) increase), but not with live birth rates. No associations were noted with sulfur dioxide or larger particulate matter (PM(10))., Conclusions: The effects of declining air quality on reproductive outcomes after IVF are variable, cycle-dependent and complex, though increased NO(2) is consistently associated with lower live birth rates. Our findings are limited by the lack of direct measure of pollutants at homes and lab sites.

Objective: To describe fertility patients' preferences for disposition of cryopreserved embryos and determine factors important to these preferences., Design: Cross-sectional survey conducted between June 2006 and July 2007., Setting: Nine geographically diverse U.S. fertility clinics., Patient(s): 1020 fertility patients with cryopreserved embryos., Intervention(s): Self-administered questionnaire., Main Outcome Measure(s): Likelihood of selecting each of five conventional embryo disposition options: store for reproduction, thaw and discard, donate to another couple, freeze indefinitely, and donate for research; likelihood of selecting each of two alternative options identified in previous research: placement of embryos in the woman's body at an infertile time, or a disposal ceremony; importance of each of 26 considerations to disposition decisions; and views on the embryo's moral status., Result(s): We found that 54% of respondents with cryopreserved embryos were very likely to use them for reproduction, 21% were very likely to donate for research, 7% or fewer were very likely to choose any other option. Respondents who ascribed high importance to concerns about the health or well-being of the embryo, fetus, or future child were more likely to thaw and discard embryos or freeze them indefinitely., Conclusion(s): Fertility patients frequently prefer disposition options that are not available to them or find the available options unacceptable. Restructuring and standardizing the informed consent process and ensuring availability of all disposition options may benefit patients, facilitate disposition decisions, and address problems of long-term storage., (Copyright 2010 American Society for Reproductive Medicine. All rights reserved.)

Context: Low birthweight has been associated with metabolic and reproductive abnormalities in adults., Objective: The aim of the study was to examine the relationship between birthweight and gestational age and its association with reproductive and metabolic phenotypes in women with PCOS and their first-degree relatives., Design and Setting: We conducted a family-based study of PCOS at an academic health center., Patients or Other Participants: A total of 1038 individuals (845 females and 193 males) from the cohort and 168 controls participated in the study., Main Outcome Measures: The association between birthweight and familial phenotype was measured., Results: Self-reported and actual birthweight were highly correlated [Spearman correlation coefficient (r) = 0.81; 95% CI, 0.66, 0.89; P = 0.001) and concordant (concordance correlation coefficient = 0.86; 95% lower limit = 0.78). We noted that birthweight for both genders in PCOS families and controls fell within the 10th and 90th percentiles for gestational age based on U.S. population norms. The 50th percentiles for a gestational age of 40 wk were very similar (3409 g in PCOS, 3455 g for controls, and 3495 g for the United States). There were no significant associations between phenotype and birthweight in PCOS probands. Furthermore, there were not any significant relationships between phenotype and birthweight in female or male family members of the PCOS probands., Conclusions: Birthweight in PCOS families mirrors control and U.S. population data, even corrected for gestational age, and has no substantive association with reproductive and metabolic abnormalities in women with PCOS, their female relatives, or their male relatives.

Objective: To examine the relationship of male obesity and reproductive function., Design: Observational study., Setting: Academic medical center., Patient(s): Eighty-seven adult men, body mass index (BMI) range from 16.1 to 47.0 kg/m(2) (mean = 29.3 kg/m(2); SD = 6.5 kg/m(2))., Intervention(s): None., Main Outcome Measure(s): Reproductive history, physical examination, inhibin B, FSH, LH, T, and unbound T levels, and semen analysis., Result(s): Body mass index was negatively correlated with testosterone (r = -0.38), FSH (r = -0.22), and inhibin B levels (r = -0.21) and was positively correlated with E(2) levels (r = 0.34). Testosterone also negatively correlated with skinfold thickness (r = -0.30). There was no correlation of BMI or skinfold thickness with semen analysis parameters (sperm density, volume, motility, or morphology). Inhibin B level correlated significantly with sperm motility (r = 0.23). Men with paternity had lower BMIs (28.0 kg/m(2) vs. 31.6 kg/m(2)) and lower skinfold thickness (24.7 mm vs. 34.1 mm) than men without., Conclusion(s): Obesity is an infertility factor in otherwise normal men. Obese men demonstrate a relative hypogonadotropic hypogonadism. Reduced inhibin B levels and diminished paternity suggest compromised reproductive capacity in this population.

A woman presented with symptoms of vaginal bleeding and pelvic pain shortly after hysteroscopic sterilization. Sonographic and hysteroscopic images of a dislodged Essure microinsert (Conceptus Inc., San Carlos, CA) are provided.

Context: Continuous oral contraception may better suppress the ovary and endometrium, lending itself to the treatment of other medical conditions., Objective: Our objective was to determine the effects of continuous vs. cyclical oral contraception., Design: This was a randomized double-blind trial., Setting: This trial was performed at an academic medical center in Pennsylvania., Patients: A total of 62 healthy women with regular menses were included in the study., Intervention: Cyclical oral contraception (21-d active/7-d placebo given for six consecutive 28-d cycles) vs. continuous (168-d active pill) therapy using a monophasic pill (20 microg ethinyl estradiol and 1 mg norethindrone acetate) was examined., Main Outcome Measures: The primary outcome was vaginal bleeding, and secondary outcomes included hormonal, pelvic ultrasound, quality of life, and safety measures., Results: There was no statistically significant difference in the number of total bleeding days between groups, but moderate/heavy bleeding was significantly greater with the cyclical regimen [mean 11.0 d (sd 8.5) vs. continuous 5.2 d (sd 6.8); P = 0.005], with both groups decreasing over time. Endogenous serum and urinary estrogens measured over six cycles were significantly lower (P = 0.02 and 0.04, respectively) in the continuous group than the cyclical group. Women in the continuous group also had a smaller ovarian volume and lead follicle size over the course of the trial by serial ultrasound examinations. The Moos Menstrual Distress Questionnaire showed that women on continuous therapy had less associated menstrual pain (P = 0.01) and favorable improvements in behavior (P = 0.04) during the premenstrual period., Conclusions: Continuous oral contraception does not result in a reduction of bleeding days over a 168-d period of observation but provides greater suppression of the ovary and endometrium. These effects are associated with improved patient symptomatology.

Objective: To examine the effects of metformin and rosiglitazone, alone and in combination, on endometrial histology and ovarian steroid production., Study Design: Randomized open-label study of metformin and rosiglitazone in 16 women with polycystic ovary syndrome (PCOS) performed at a single academic health center. The study consisted of a 6-week baseline observation period, a 3-month treatment period of single-agent therapy (rosiglitazone or metformin), and then a 3-month period of combined therapy., Results: Abnormal endometrial histology was found in 3 subjects at baseline, including 1 case of adenocarcinoma of the endometrium in an asymptomatic subject, who was excluded from further study. The 2 other abnormal cases (simple hyperplasia) resolved with treatment. Three months of single-agent therapy showed a benefit of rosiglitazone (n = 9) over metformin (n = 6) in terms of reducing circulating unbound testosterone levels (-11.8; 95% CI: -21.7 to -2.0 ng/dL) and 2-hour glucose (-42.0; 95% CI: -76.2 to -7.8 mg/dL), 2-hour insulin (-150.4; 95% CI: -272.7 to -28.1 microU/mL) as well as a significant decrease in integrated levels of glucose and insulin by area under the curve analysis, all obtained from oral glucose tolerance testing. Daily urinary progestin-to-estrogen ratios improved on rosiglitazone compared to metformin therapy (0.08; 95% CI: 0.02 to 0.14). Ovulatory rates tended to improve on both single-agent and combined treatments (30/90 cycles, 33%), compared to baseline ovulatory rate (2/15, 13%). Despite 6 months of therapy alone or in combination, 5 women displayed no evidence of biochemical ovulation by urinary or serum progestin measurements., Conclusion: This study provides preliminary evidence that insulin-sensitizing drugs may have beneficial effects on the endometrium, although the exact mechanism beyond improving ovulatory function is still unknown. In addition, we suggest that rosiglitazone may be more beneficial than metformin therapy on raised insulin and androgen levels in an obese PCOS population. Combined therapy did not demonstrate significant benefit above and beyond single-agent therapy.

Objective: To evaluate the association between obesity and the outcome of superovulation and intrauterine insemination (IUI) in infertile ovulatory women., Design: Retrospective chart review., Setting: University-based infertility clinic., Patient(s): Three hundred thirty-three ovulatory women, grouped by body mass index (BMI) categories, who received superovulation and IUI for treatment of infertility., Intervention(s): None., Primary Outcome: cycle fecundity., Secondary Outcomes: total dose of gonadotropins, serum level of E(2), and number of follicles >or=17 mm on the day of hCG injection., Result(s): Adjusted cycle fecundity was not different among BMI groups (underweight: 0.14 [95% CI: {0.07, 0.29}], normal weight: 0.12 [95% CI: {0.09, 0.16}], overweight: 0.17 [95% CI: {0.12, 0.24}], and obese: 0.14 [95% CI: {0.08, 0.23}]). Adjusted total gonadotropin dose (IU/cycle) was greater in obese women than in underweight or normal-weight women. Although the numbers of large follicles were not different, E(2) levels (pg/mL) were lower in obese women than in normal-weight and overweight women., Conclusion(s): Our sample of ovulatory infertile women demonstrated that treatment-related cycle fecundity is unaffected by obesity. We conclude that obese, infertile ovulatory women require a greater dose of gonadotropins to achieve similar levels of superovulation than normal, underweight or overweight women.

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder of unexplained hyperandrogenic chronic anovulation. Experts have recommended including the morphology and volume of the ovary in the diagnostic criteria for PCOS. We performed this study to determine whether there was an association between the morphology and size of the ovaries and markers of insulin sensitivity as determined by dynamic testing within women with PCOS or compared with a group of control women. We then examined reproductive parameters. We studied 88 unrelated PCOS women and 21 control women, aged 17-45 yr. All were in the early follicular phase or its equivalent (no follicle with > 10 mm diameter and anovulatory serum progesterone level < 3 ng/ml). Subjects underwent on the same day a phlebotomy for baseline hormones, a 2-h oral glucose tolerance test, and transvaginal ultrasound to determine the morphology and volume of the ovaries. Ninety-five percent (84 of 88) of women with PCOS and 48% (10 of 21) of the control women had polycystic ovaries using the criteria of at least one ovary greater than 10 cm3 (PCOV) and/or polycystic ovary morphology (PCOM) using the criteria of 10 or more peripheral follicular cysts 8 mm in diameter or less in one plane along with increased central ovarian stroma. PCOM was a better discriminator than PCOV between PCOS and control women. The odds of women with PCOS having PCOM were elevated 50-fold compared with controls (odds ratio, 50; 95% confidence interval, 10-240; P < 0.0001), whereas the odds of PCOV were elevated 5-fold in women with PCOS (odds ratio, 4.6; 95% confidence interval, 1.7-12.6; P = 0.003). Neither the insulin sensitivity index, fasting or 2-h values, or any integrated measures of glucose and insulin varied in women according to either morphology or volume, nor was there an association with circulating androgen levels. Women with PCOS and PCOM had lower FSH levels than women with PCOS and non-PCOM. Women with PCOS and PCOV had a higher LH to FSH ratio than women without PCOV and PCOS. These data support the hypothesis that polycystic ovaries are an abnormal finding. However, neither the morphology nor the volume of the ovaries is associated with distinctive metabolic or reproductive phenotypes in women with PCOS.

Objective: To ascertain temporal trends in the number and share of papers originating from work sites in the ten districts of The American College of Obstetricians and Gynecologists (ACOG) and to identify demographic predictors of variance among the districts., Methods: The work sites of the first authors of papers published in Obstetrics & Gynecology were determined for selected years since 1985 and sorted by ACOG district. Three related journals (Fertility and Sterility, Gynecologic Oncology, and the American Journal of Obstetrics and Gynecology) were similarly analyzed for the year 2000. Demographic variables, including numbers of ACOG Fellows, residencies, subspecialty fellowships, and medical schools, were analyzed with multivariable regression for the most predictive variables for number of papers among ACOG districts., Results: The number and share of papers published in Obstetrics & Gynecology written by authors working in ACOG districts have been declining steadily since 1985, in contrast to the number of papers arising from locations outside of ACOG districts. Analysis of demographic factors for number of papers from four specialty journals in the year 2000 revealed that the number of medical schools in the district (R(2) = 0.79) was the most predictive (P <.001)., Conclusion: Efforts to identify and correct factors associated with a decline in the number of published papers should focus on conditions in medical schools.

Objective: To determine the long-term effect of full term teen pregnancy on peak hip bone mineral density., Design: Longitudinal observational study., Setting: Academic clinical research center., Patient(s): Sixteen non-Hispanic white females: 4 cases and 12 matched controls who are part of The Penn State Young Women's Health Study and have been studied from ages 12 to 21., Main Outcome Measures: Four of the subjects had uncomplicated full-term pregnancies between ages 16.5 and 19.5 years., Intervention(s): The cases and controls were matched for body mass index at age 12 years, total body bone mineral content at age 12 years, age of menarche, and sports-exercise score during ages 12-18 years. They were then compared with respect to bone measures, cardiovascular disease risk factors, and endocrine profiles at ages 19-21 years., Result(s): The four teen mothers had significantly lower adult hip bone mineral density than did the controls (0.89 g/cm(2) vs. 0.99 g/cm(2); P=.03). The reproductive hormone patterns of the cases were not statistically significantly different from those of the controls, yet the cases showed a postmenopausal blood lipid pattern., Conclusion(s): The persistent reduction in hip bone mineral density of the cases is consistent with significantly increased risk of future hip fracture.

Objective: To describe a rare case of spontaneous conception in a patient with a preexisting metastatic ovarian cancer., Design: Case report., Setting: University hospital., Patient(s): A 39-year-old Asian woman who conceived while undergoing an evaluation for primary infertility and newly detected bilateral adnexal masses., Intervention(s): Staging laparotomy and total abdominal hysterectomy and bilateral salpingo-oophorectomy., Main Outcome Measure(s): Anatomic pathology diagnosis., Result(s): Blighted ovum and stage IIIC endometrioid adenocarcinoma of ovary., Conclusion(s): Metastatic ovarian cancer does not prevent either spontaneous ovulation or spontaneous conception.

Endometriosis is an adhesion disorder characterized by the presence of endometrial tissue in ectopic sites outside the uterus. The disease is associated with dysmenorrhea, pelvic pain and infertility. Although endometriosis is the most common gynecologic disorder, relatively little is known regarding its etiology, pathogenesis and the course of the disease. This situation is primarily due to the absence of experimental systems to examine the mechanism of endometrial cell adhesion, role of inflammatory cells and the interactions of epithelial, and stromal cells with the peritoneum and ovarian tissue leading to the development of this disorder. Dissociated human endometrial cells were suspended in peritoneal fluids of individuals with and without endometriosis and were injected into the peritoneal cavity of athymic mice. This led to development of ectopic adhesions of endometrial cells at the peritoneal and ovarian surfaces. Endometrial cells which were marked with fluorescent lipophylic dyes, prior to intraperitoneal injection, could be visualized without surgery at such sites. The studies demonstrate a model for endometriosis in athymic mice.

Women with polycystic ovary syndrome (PCOS) are insulin resistant, have insulin secretory defects, and are at high risk for glucose intolerance. We performed this study to determine the prevalence of glucose intolerance and parameters associated with risk for this in PCOS women. Two-hundred and fifty-four PCOS women, aged 14-44 yr, were prospectively evaluated at 2 centers, 1 urban and ethnically diverse (n = 110) and 1 rural and ethnically homogeneous (n = 144). The rural PCOS women were compared to 80 control women of similar weight, ethnicity, and age. A 75-g oral glucose challenge was administered after a 3-day 300-g carbohydrate diet and an overnight fast with 0 and 2 h blood samples for glucose levels. Diabetes was categorized according to WHO criteria. The prevalence of glucose intolerance was 31.1% impaired glucose intolerance (IGT) and 7.5% diabetes. In nonobese PCOS women (body mass index, <27 kg/m2), 10.3% IGT and 1.5% diabetes were found. The prevalence of glucose intolerance was significantly higher in PCOS vs. control women (chi2 = 7.0; P = 0.01; odds ratio = 2.76; 95% confidence interval = 1.23-6.57). Variables most associated with postchallenge glucose levels were fasting glucose levels (P < 0.0001), PCOS status (P = 0.002), waist/hip ratio (P = 0.01), and body mass index (P = 0.021). The American Diabetes Association criteria applied to fasting glucose significantly underdiagnosed diabetes compared to the WHO criteria (3.2% vs. 7.5%; chi2 = 4.7; P = 0.046; odds ratio = 2.48; 95% confidence interval = 1.01-6.69). We conclude that 1) PCOS women are at significantly increased risk for IGT and type 2 diabetes mellitus at all weights and at a young age; 2) these prevalence rates are similar in 2 different populations of PCOS women, suggesting that PCOS may be a more important risk factor than ethnicity or race for glucose intolerance in young women; and 3) the American Diabetes Association diabetes diagnostic criteria failed to detect a significant number of PCOS women with diabetes by postchallenge glucose values.

The objective of this study was to use an anatomically arrayed whole-body phantom to measure radiation exposure to the ovaries and uterus during standard dual-energy Xray absorptiometry (DXA) scanning. DXA instrument manufacturers' published entrance skin exposure is about 3 mR (0.77 microC/kg), which is equivalent to the radiation exposure received during a transcontinental plane trip. Nonetheless, since DXA scanning is used more frequently with very young females, the need for pregnancy testing has become an issue that requires attention and formulation of research guidelines. We attached thermoluminescent dosimeters (TLDs) to anatomically arrayed balloon models for ovaries and the uterus, and placed these in the appropriate sites within a small human skeleton along with appropriate amounts of aqueous and fat soft tissue equivalents. Whole-body scanning with a Hologic QDR-2000W was performed 10 times with the pencil beam mode and, using separate TLD detectors, 10 times with the fan beam mode. Overall, the average exposures at skin entrance were 0.89 mR (0.23 microC/kg) with doses for the ovaries of 0.52 mrad (5.2 microgy) and 0.59 mrad (5.9 microgy) for the uterus. These doses are equivalent to 2 d of ambient background radiation in central Pennsylvania or 1 h of flying at 39,000 ft. Although different DXA models by Hologic and DXA instruments by other manufacturers will have different radiation outputs, we believe that these low radiation levels do not require pregnancy testing or questioning of whether the scan subject might be pregnant.