Search

This study examined perspectives on the ethical implications of preimplantation genetic testing (PGT) among individuals who actually (not hypothetically) used or considered using PGT. Most of the prior patient-centered research on PGT ethics used qualitative designs (9 out of the 11 articles) and focused only on single gene testing. This cross-sectional study used an anonymous online questionnaire; 15 items assessed potential ethical concerns involved in PGT decision-making, including clinical indications for PGT, the greater implications of PGT for society, and unused embryo disposition. N = 207 individuals (mean female/male age 35.7/38.9 years, 21% Hispanic or non-White) who had recently used or considered using PGT for single gene (60%) or for chromosomal testing (40%) completed the questionnaire. Most respondents supported PGT screening for disease conditions with childhood or adult onset that are untreatable (64%-85% across items); most opposed PGT for trait selection (76%-81%). Most respondents agreed that PGT aids in parental decision-making (66%-67%), although some expressed concern over potential unforeseen consequences (25%-30%). Regarding disposition of embryos without known genetic abnormalities, most respondents favored freezing indefinitely (86%) or donating to another family (69%), while for embryos with genetic abnormalities, most respondents favored donating to research (78%) or destroying them (62%). Stratification by religious affiliation revealed several differences, such as less acceptance of PGT for diseases that occur in adulthood and have no treatment options among Protestants (p = .015) and greater willingness to donate surplus embryos to research among participants without a religious affiliation (p

What are the ethical perspectives of preimplantation genetic testing in patients using/considering PGT-A compared to those using/considering PGT-M? A 17-item questionnaire administered online was used to assess ethical perspectives in US patients who recently used/considered PGT-A (n=80) vs. those who used/considered PGT-M (n=72). Kruskal-Wallis, Chi-square, and Fisher exact tests were conducted with STATA. Most PGT-A and PGT-M users/considerers supported using PGT to screen for diseases fatal in childhood (86-89%) and those causing lifelong disabilities (76-79%) and opposed using PGT to screen for non-medical physical (80-87%) or intellectual traits (74-86%). Both groups agreed that PGT aids in parental decision-making, although some expressed concern over its potential to lead to unforeseen consequences for society and the PGT offspring. More PGT-M than PGT-A users/considerers opposed implanting genetically abnormal embryos when requested by parents (29% PGT-A vs. 56% PGT-M, p = 0.007). For embryo disposition, more PGT-A users/considerers favored freezing (95% PGTA vs. 82% PGT-M, p = 0.018) or donating genetically normal embryos to research (73% PGT-A vs. 57% PGT-M, p = 0.044), while more PGT-M users/considerers supported donating embryos with known genetic abnormalities to research (56% PGT-A vs. 81% PGT-M, p = 0.001). Regardless of the reason for using PGT, users generally agreed on the acceptable and unacceptable uses for it, as well as the potential societal impact. PGT-M users/considerers expressed more opposition than PGT-A users/considerers to implanting embryos with a genetic alteration when requested by the parents.

To use a questionnaire to determine the levels of maternal decision-related distress, clarity of the pros and cons, and certainty when considering prenatal genetic diagnostic testing; and to assess the relationship between these constructs and patient characteristics.Cross-sectional study. Voluntary, anonymous questionnaires distributed 2017-2019 to women referred for invasive prenatal genetic testing. Excluded: English or Spanish illiterate. Maternal characteristics were collected. Questions evaluated distress, decisional certainty, and decisional clarity on a 5-point Likert scale (range: 0 = low/uncertain/unclear to 4 = high/certain/clear). Analysis: non-parametric Kruskal-Wallis, correlation statistics, and ANOVA.Forty-four female patients completed it. Most were married, white, Catholic, and multiparous. 58% had already made a testing decision. Patients expressed low distress levels (mean 1.18 ± 0.80) and expressed high decisional certainty (mean 3.28 ± 0.76) and clarity (mean 3.30 ± 0.99). Decisional certainty and clarity were positively correlated (Higher maternal distress scores were associated with lower decisional certainty and decisional clarity in women considering prenatal genetic testing.

Objective To provide an update on single-gene mutations identified as causative for pathologic diminished ovarian reserve (DOR) to inform clinical screening recommendations. Evidence Review A systematic review of the literature was performed in accordance with PRISMA guidelines using PubMed and EMBASE databases. Only full-text articles in English were included and articles were excluded that did not relate to single-gene causes of pathologic DOR in humans. The search was supplemented using references of the included articles. Primary outcomes included prevalence ratios (PRs) for 12 genes associated with pathologic DOR. Result(s) A total of 550 articles were screened, with 108 articles included for review. Fifteen observational studies had prevalence data available for quantitative analysis. Elevated prevalence ratios were found in women with DOR for the FMR1 premutation and FMR2 mutations as well as single-nucleotide polymorphisms in the BMP15, GDF9, FSHR, and NOBOX genes. Although some studies have suggested an increased prevalence of BRCA1 and BRCA2 mutations in women with DOR, the prevalence in the controls in the included studies was elevated and PRs did not achieve statistical significance. Conclusion(s) Women diagnosed with DOR are at an increased risk of carrying mutations in FMR1, FMR2, and variants in BMP15, GDF9, FSHR, and NOBOX genes. Of these, the only gene identified as having the potential to cause significant deleterious effects in offspring is the FMR1 premutation, which supports current national screening guidelines. Further studies of BRCA1 and BRCA2 are needed to determine whether pathologic DOR might be associated with mutations in those genes.

Background A test that helps predict the time to the final menstrual period (FMP) has been sought for many years. Objective To assess the ability of antimullerian hormone (AMH) measurements to predictions the time to FMP. Design Prospective longitudinal cohort study. Setting The Study of Women’s Health Across the Nation. Participants and Measurements AMH and FSH were measured in 1537 pre- or early perimenopausal women, mean age 47.5 ± 2.6 years at baseline, then serially until 12 months of amenorrhea occurred. AMH was measured using a 2-site ELISA with a detection limit of 1.85 pg/mL. Main Outcome Measure Areas under the receiver operating curves (AUC) for AMH-based and FSH-based predictions of time to FMP, stratified by age. Probabilities that women would undergo their FMP in the next 12, 24, or 36 months across a range of AMH values were assessed. Results AUCs for predicting that the FMP will occur within the next 24 months were significantly greater for AMH-based than FSH-based models. The probability that a woman with an AMH 100 pg/mL would not undergo her FMP within the next 12 months ranged from 97% in women Conclusions AMH measurement helps estimate when a woman will undergo her FMP, and, in general, does so better than FSH.

OBJECTIVE: To analyze psychometric properties of two novel instruments assessing decisional distress and uncertainty experienced by individuals considering preimplantation genetic testing (PGT). METHODS: The new PGT Decisional Distress instrument (22 items) assesses negative/positive emotions. The new PGT Decisional Uncertainty instrument assesses Clarity about test benefits/disadvantages (5 items) and Certainty of having adequate information/support to make a good decision (7 items). Scales ranged from 0 to 4. Psychometrics (central tendencies, internal consistency reliability, and discriminant validity) were evaluated. Stratified analysis by decision stage was conducted. All participants had considered or used PGT in the previous 6 months. RESULTS: N = 106 females (mean age 36.5 ± 4.8 years; 16% non-Caucasian; 9% Hispanic) across 16 US states completed an online anonymous questionnaire. On average, respondents reported minimal distress (mean 0.96), high clarity (mean 3.26), and high certainty (mean 3.06), particularly those who had already decided compared to undecided women (P ≤ .02). Instruments had excellent internal consistency (Cronbach's α's 0.92-0.94) and displayed sufficient inter-individual variability (SD's 0.75-0.89). Correlations confirmed expected patterns of association between instruments (P's < .01), indicating discriminant validity. CONCLUSION: We document initial reliability and validity of new instruments to measure emotional distress and uncertainty in female patients who have recently considered PGT for single-gene or chromosomal disorders.

The increasing technical complexity and evolving options for repro-genetic testing have direct implications for information processing and decision making, yet the research among patients considering preimplantation genetic diagnosis (PGD) is narrowly focused. This review synthesizes the literature regarding patient PGD decision-making factors, and illuminates gaps for future research and clinical translation. Twenty-five articles met the inclusion criteria for evaluating experiences and attitudes of patients directly involved in PGD as an intervention or considering using PGD. Thirteen reports were focused exclusively on a specific disease or condition. Five themes emerged: (1) patients motivated by prospects of a healthy, genetic-variant-free child, (2) PGD requires a commitment of time, money, energy and emotions, (3) patients concerned about logistics and ethics of discarding embryos, (4) some patients feel sense of responsibility to use available technologies, and (5) PGD decisions are complex for individuals and couples. Patient research on PGD decision-making processes has very infrequently used validated instruments, and the data collected through both quantitative and qualitative designs have been inconsistent. Future research for improving clinical counseling is needed to fill many gaps remaining in the literature regarding this decision-making process, and suggestions are offered.

There are large variations in the number of oocytes within each woman, and biologically, the total quantity is at its maximum before the woman is born. Scientific knowledge is limited about factors controlling the oocyte pool and how to measure it. Within fertility clinics, there is no uniform agreement on the diagnostic criteria for each common measure of ovarian reserve in women, and thus, studies often conflict. While declining oocyte quantity/quality is a normal physiologic occurrence as women age, some women experience diminished ovarian reserve (DOR) much earlier than usual and become prematurely infertile. Key clinical features of DOR are the presence of regular menstrual periods and abnormal-but-not-postmenopausal ovarian reserve test results. A common clinical challenge is counseling patients with conflicting ovarian reserve test results. The clinical diagnosis of DOR and the interpretation of ovarian reserve testing are complicated by changing lab testing options and processing for anti-mullerian hormone since 2010. Further, complicating the diagnostic and research scenario is the existence of other distinct yet related clinical terms, specifically premature ovarian failure, primary ovarian insufficiency, poor ovarian response, and functional ovarian reserve. The similarities and differences between the definitions of DOR with each of these four terms are reviewed. We recommend greater medical community involvement in terminology decisions, and the addition of DOR-specific medical subject-heading search terms.

Objective To examine the magnitude and predictors of emotional reactions to an infertility diagnosis in two groups of women: those with diminished ovarian reserve (DOR), and those clinically diagnosed with an anatomical cause of infertility (ACI). Design Cross-sectional study. Setting Academic and private fertility clinics. Patient(s) Women diagnosed with DOR (n = 51) and women diagnosed with ACI (n = 51). Intervention(s) Not applicable. Main Outcome Measure(s) Fertility Problem Inventory (infertility distress), Rosenberg Self-Esteem Scale, Health Orientation Scale (emotional reactions to receiving a diagnosis). Result(s) Women with DOR had statistically significantly higher infertility distress scores than women with ACI and higher scores on subscales assessing distress from social concerns, sexual concerns, and a need for parenthood. In both groups, higher self-esteem was associated with lower infertility distress. Hierarchical multiple regression analyses revealed that for women with DOR and those with ACI lower infertility distress but not self-esteem predicted a more positive emotional reaction toward receiving a fertility diagnosis. Conclusion(s) Women diagnosed with DOR have greater infertility distress but similar self-esteem and emotional reactions to their diagnosis compared with women who have an anatomical cause of infertility. These results suggest that for both groups distress surrounding infertility itself may influence the way women respond to learning the cause of their infertility.

PURPOSE: Twelve percent of women in the USA will develop invasive breast cancer in their lifetime, and that risk increases to 80% if they carry a BRCA1 or BRCA2 mutation. BRCA1/2 mutations are thought to potentially affect ovarian reserve and/or fertility. METHODS: PubMed and PubMed Central were searched for publications on ovarian reserve–related outcomes (i.e., AMH and response to controlled ovarian hyperstimulation (COH) protocols) that were reported in relation to BRCA1 and/or BRCA2 mutations from 1950 through May 2019. A meta-analysis was conducted to create forest plots and summary effect measures using Review Manager 5.3. RESULTS: This article reviews the 16 qualifying publications. There were several fundamental methodological differences in the study designs and outcome details reported in AMH studies. Summary statistics found no difference in AMH levels between BRCA1/2+ women as compared with controls (Z overall test effects p ≥ 0.45). Regarding responses to COH, there were overall non-significantly fewer total and mature numbers of oocytes retrieved in BRCA1/2+ cases as compared with controls (meta-analysis Z overall test effects p ≥ 0.40). CONCLUSIONS: While the summary measures indicate no significant differences in AMH levels between BRCA1/2+ cases and controls, readers should be aware that there are significant methodological differences in the AMH reports. Additionally, the response to COH protocols does not seem to be significantly lower in BRCA1/2 mutation carriers in the existing literature. Continued research on both of these clinical parameters would be beneficial for patient counseling.

The process of deciding whether to pursue preimplantation genetic testing (PGT) of an embryo is highly stressful for individuals and couples and has adverse emotional consequences (e.g. distress and uncertainty). PGT influences patients’ lives in both positive and negative ways and is experienced at an individual level, as a dyadic unit, as a family member and as part of the society. Here, we argue that providing a conceptual framework with which to understand the `experience of decision making’ about PGT for monogenic disease (PGT-M) testing specifically, as well as the factors contributing to `decisional distress’ and `uncertainty’ that patients endure as a result—apart from what decision they make—is crucial to optimizing patient counseling, satisfaction and outcomes in the field of ART. Derived from psychological theory, the framework proposed here identifies three categories of contributing factors to decisional distress and uncertainty in considering PGT-M; namely, ‘intraindividual’, ‘interpersonal’ and ‘situational’ factors. We reviewed evidence from the PGT literature to inform our framework. Well-accepted theories of stress and health decision making were also reviewed for their relevance to PGT-M decision making, focusing on potential distress and uncertainty. Our novel conceptual framework can be used to inform clinical practice, to advance research and to aid the development of interventions for individuals and couples who are deciding whether or not to use PGT-M. Alleviating emotional distress and uncertainty can improve patients’ well-being during their reproductive journey.

FMR1 premutation carriers (55-199 CGG repeats), and potentially women with high normal (35-44) or low normal (

FMR1 CGG trinucleotide repeat expansions are associated with Fragile X syndrome (full mutations) and primary ovarian insufficiency (premutation range); the effect of FMR1 on the success of fertility treatment is unclear. The effect of FMR1 CGG repeat lengths on IVF outcomes after ovarian stimulation was reviewed. PubMed was searched for studies on IVF-related outcomes reported by FMR1 trinucleotide repeat length published between 2002 and December 2017. For women with CGG repeats in the normal (

We explored whether AMH, as a surrogate for oocyte supply, varies by FMR1 genotype in women diagnosed with diminished ovarian reserve (DOR), a subset of the Primary Ovarian Insufficiency phenotype. Research is inconsistent on the relationship between AMH and FMR1 repeat length, controlling for age.Seventy-nine cycling women diagnosed with DOR, and without a family history of fragile X syndrome, provided blood for FMR1 and AMH testing. DOR was defined as elevated FSH and/or low AMH and/or low antral follicle count, with regular menses. FMR1 CGG repeats were stratified by the larger allele35 repeats (n = 70) v. ≥35 repeats (n = 9). Quadratic and linear models were fit to predict log (AMH) controlling for age. The AMH sample used as the outcome variable was drawn at a later date than the diagnostic AMH.Serum AMH concentration median was 0.30 ng/mL; Ages ranged from 26-43 years. A quadratic model (including age(2)) did not show a relationship with FMR1 CGG level (p-value = 0.25). A linear model of log (AMH), corresponding to an exponential decline of AMH with increasing age, was significantly different, and had a steeper slope, for women with ≥ 35 CGG repeats than women with 35 repeats (p = 0.035).Findings suggest a greater rate of follicular loss that starts at later ages in women with DOR and ≥ 35 CGG repeats.

Diminished ovarian reserve (DOR) and premature ovarian failure are associated with elevated FMR1 CGG repeat alleles. We assessed pretest attitudes about potentially carrying the FMR1 premutation (FXP) (>55 CGG repeats) among reproductive age women compared with attitudes after learning their non-carrier status. Ninety-two women with DOR, regular menses and no family history of Fragile X Syndrome underwent FMR1 testing and completed attitudinal questionnaires before (T1) and 3 months after learning the test results (T2). The analysis utilized signed rank tests and α = 0.05. Very few women thought they were likely to have a FXP (6.6 %). More participants thought FMR1 premutations were “serious” at T2 (62.9 %) than at T1 (46.1 %, p < 0.0003). When asked at T1 to “describe your feelings when you consider that you are potentially a carrier” of a FXP, 10 % had negative feelings, 50 % felt ambivalent, and 40 % had positive feelings. At T2, feelings about not being a carrier were significantly more favorable (p < 0.0001): negative (0 %), ambivalent (6.5 %), positive (93 %). Corroborating prior reports, few women had a negative view of FXP, perhaps anticipating that carrying the FXP explains their infertility. Perception of the seriousness of FXP increased after learning they did not carry the FXP, which would be predicted by health belief models.

About 10 % of infertile/subfertile women are diagnosed with diminished ovarian reserve (DOR), of which

Objective To study whether reported, but inconsistent, associations between the FMR1 CGG repeat lengths in the intermediate, high normal, or low normal range differentiate women diagnosed with diminished ovarian reserve (DOR) from population controls and whether associations vary by race/ethnic group. Design Case-control study. Setting Academic and private fertility clinics. Patient(s) DOR cases (n = 129; 95 Whites, 22 Asian, 12 other) from five U.S. fertility clinics were clinically diagnosed, with regular menses and no fragile X syndrome family history. Normal fertility controls (n = 803; 386 Whites, 219 African-Americans, 102 Japanese, 96 Chinese) from the United States–based SWAN Study had one or more menstrual period in the 3 months pre-enrollment, one or more pregnancy, no history of infertility or hormone therapy, and menopause ≥46 years. Previously, the SWAN Chinese and Japanese groups had similar FMR1 CGG repeat lengths, thus they were combined. Intervention(s) None. Main Outcome Measure(s) FMR1 CGG repeat lengths. Result(s) Median CGG repeats were nearly identical by case/control group. DOR cases had fewer CGG repeats in the shorter FMR1 allele than controls among Whites, but this was not significant among Asians. White cases had fewer CGG repeats in the shorter allele than Asian cases. No significant differences were found in the high normal/intermediate range between cases and controls or by race/ethnic group within cases in the longer allele. Conclusion(s) This study refutes prior reports of an association between DOR and high normal/intermediate repeats and confirms an association between DOR and low normal repeats in Whites.

FMR1 premutation carriers (55-199 CGG repeats), and potentially women with high normal (35-44) or low normal (

To analyze insulin resistance (IR) and determine the need for a 2-hour oral glucose tolerance test (OGTT) for the identification of IR and impaired glucose tolerance (IGT) in lean nondiabetic women with polycystic ovary syndrome (PCOS).This was a cross-sectional analysis of treatment-naive women with PCOS who enrolled in a university-based clinical trial. Nondiabetic women with PCOS based on the Eunice Kennedy Shriven National Institute of Child Health and Human Development (NICHD) definition, aged 18-43 years and weighing ≤113 kg, were evaluated. Glucose and insulin levels were assessed at times 0, 30, 60, 90, and 120 minutes after a 75-g glucose load. Lean was defined as body mass index (BMI)25 kg/m(2). Multiple linear regression was performed.A cohort of 78 women was studied. The prevalence of IR was 0% among lean women vs. 21% among nonlean subjects based on fasting insulin I(0) and 40%-68% based on two different homeostatic model assessment (HOMA) cutoff points (p 0.005). All women with IR had a BMI ≥ 28. Controlling for age and race, BMI explained over 57% of the variation in insulin fasting (I(o)), glucose fasting/Io (G(o)/I(o)), the qualitative insulin sensitivity check index (QUICKI), and HOMA and was a highly significant predictor of these outcomes (p 0.0001). Only 1 of 31 (3%) of the lean PCOS women had IGT based on a 2-hour OGTT, and no lean subjects had IGT based on their fasting blood glucose.Diabetes mellitus, IGT, and IR are far less common in young lean women with PCOS compared with obese women with PCOS. These data imply that it is unnecessary to routinely perform either IR testing or 2-hour OGTT in lean women with PCOS; however, greater subject accumulation is needed to determine if OGTT is necessary in lean women with PCOS. BMI is highly predictive of both insulin and glucose levels in women with PCOS.

Introduction A sample of Latino women from an ambulatory obstetrics and gynecology (Ob/Gyn) clinic were queried about their sexual functioning using the Changes in Sexual Functioning Questionnaire (CSFQ-14). Aim To assess the degree of self-reported sexual complaints in a sample of Latino women living in the United States; to assess if the prevalence of symptoms differs from one study of women living in Spain; and to determine if sexual complaints were associated with demographics, sexual/reproductive history, selected medications, or religious practices. Main Outcome Measures CSFQ-14 scores and demographic variables. Methods CSFQ-14 questionnaire in an out-patient, bilingual Ob/Gyn clinic in Central Virginia. Results Seventy-one native Spanish-speaking patients (59% born in Mexico) completed the U.S. Spanish version of the CSFQ-14 and a short questionnaire for potential covariates. The mean age was 28.7 years (range 17–60). Birth place was outside of the United States for 95.8% (N = 67). Eighty percent of participants had children and 96% reported being currently sexually active. Low sexual functioning, as defined by a total CSFQ score of ≤41, was found in 26 (41.3%) participants. Taking medication for depression and/or anxiety was associated with lower sexual functioning ( P = 0.03). Women who had children of any age living in the household were less likely to report low sexual functioning ( P = 0.05; P = 0.01 when restricted to infants) than women without children living in the household. Thirteen of 68 women (19.1%) reported a history of physical and/or sexual abuse, but this was not associated with low sexual functioning. There was no association between self-reported religious affiliation or church attendance frequency and sexual complaints. Respondents in our sample had lower (i.e., worse sexual function) overall CSFQ scores compared with a sample of college students in Spain ( P P Conclusions Self-reported rates of low sexual functioning were common in this cross section of Latino women. Medical treatment of depression and/or anxiety was associated with lower functioning. Direct inquiry about the sexual health of U.S. Latino women presenting for routine health care may assist in the identification of sexual difficulties in this population. Hullfish KL, Pastore LM, Mormon AJA, Wernecke Y, Bovbjerg VE, and Clayton AH. Sexual functioning of Latino women seeking outpatient gynecologic care.

Objective We theorized that a significant number of women would choose integrated screening (IS) over first trimester screening (FTS) and that demographic characteristics and baseline anxiety levels might predict which patients would choose each test. We also hypothesized that screening results might alter patients' future preferences. Method Patients underwent non-directive genetic counselling and were offered FTS or IS. Prior to undergoing nuchal translucency (NT) ultrasound, patients were given surveys. These questionnaires were repeated in the second trimester and postpartum. They focussed on the patients' background, motivations for screening and anxiety level. Results Out of 110 patients surveyed, 81 returned their initial questionnaire. 60% of these patients chose FTS and 40% chose IS. There were no demographic differences between the groups. FTS patients desired early reassurance while IS patients wanted the 'most information' and the lowest chance of needing diagnostic testing. In all, 47 women returned second trimester questionnaires and 35 women returned postpartum surveys. These surveys demonstrated that women's motivations remained constant over time. Of the five screen positive results, only one woman regretted her screening choice. Conclusion One cannot predict patients' screening preferences, thus both FTS and IS should be offered. Given non-directive counselling, patients are generally satisfied with their screening choices.

Female fragile X premutation carriers are at approximately 10-fold increased risk of premature ovarian failure (follicle stimulating hormone40 mIU/mL, amenorrhea, age40). A milder degree of premature ovarian aging (diminished ovarian reserve, where follicle stimulating hormone levels are typically 10-20 mIU/mL) results in infertility. Approximately 10% of fertility clinic patients have this diagnosis. A cohort of 20 women diagnosed with diminished ovarian reserve provided a blood specimen (confidential results), and completed structured questionnaires that assessed emotional reactions to potentially being a premutation carrier (pretest questionnaire, n = 20) and the posttest known carrier status (3 month follow-up questionnaire, n = 18 non-carriers). Responses were measured using 9-point scales, and analyzed with Fisher exact and Wilcoxon exact tests. While most participants did not view fragile X premutations as a serious medical condition, perceptions of seriousness were positively correlated with anger and regret about not knowing sooner of the potential association of these premutations with infertility. Overall, when women (pretest) imagined themselves as carriers, their self-esteem and Health Orientation Scale responses were unchanged with the exception of feeling more afraid (p = 0.004). Despite strongly wishing for negative test results, they were glad to know there might be a medical explanation for their infertility.

To assess the impact on staff communication of a standardized checklist for timeout for patients undergoing a trial of labor after cesarean section and/or elective induction at term.A comparison of presurvey and postsurvey questionnaire results for labor and delivery personnel assessing communication before and after checklist implementation.From October 2011 through March 2012, 52.9% (N=37) of 70 eligible patients had the standardized checklist for timeout performed. Prior to implementation of the checklist, 66% of respondents (48.8% of nurses, 100% of residents, 90% of attendings) slightly or strongly agreed that their opinions were heard versus 83% of respondents during the study period (73.7% of nurses, 100% of residents, 100% of attendings). Following the intervention, nurses reported that they were more likely to feel as though their opinions were heard (p = 0.05).Implementation of a formalized obstetric timeout improved the subjective perception of communication among obstetric staff. This tool has the potential to improve patient safety in labor and delivery.

Objective The purpose of this study was to evaluate differences in morbidity, progression-free interval, and survival in women with advanced epithelial ovarian cancer treated with initial chemotherapy versus initial surgery. Study design All women with epithelial ovarian cancer who were treated surgically at our hospital between January 1, 1995, and January 1, 2003, were eligible; the cases of 200 patients met the criteria and underwent retrospective chart review. Results Ninety-eight patients (49%) had initial chemotherapy, and 102 patients (51%) had initial surgery. Patients who received initial chemotherapy were more likely to have stage IV disease (initial chemotherapy, 27%, vs initial surgery, 8%; P = .042) and grade 3 disease (initial chemotherapy, 73%, vs initial surgery, 61%; P = .025). Optimal cytoreduction was achieved more often in patients who received initial chemotherapy (initial chemotherapy, 86%, vs initial surgery, 54%; P P = .022), and not treatment choice ( P = .089), had an impact on median survival. Conclusion Initial chemotherapy is a reasonable alternative to initial surgery for the treatment of selected patients with advanced epithelial ovarian cancer.

Objective The purpose of this study was to assess patient perception of fragile X premutation genetic testing (FRAX). Study design This was a cross-sectional survey of women with elevated follicle stimulating hormone levels with (premature ovarian failure or early menopause [POF/EM], n=20) or without (diminished ovarian reserve [DOR], n=20) amenorrhea. Seventy-five percent participated. Results Seventy-five percent of the DOR group and 43% of the POF/EM group desired FRAX testing. Eighty-three percent wanted to assist the scientific knowledge of FRAX, even if they did not want to know their own results. POF/EM women were more concerned than DOR women about paying out-of-pocket ( P = .001) and maintaining confidentiality insurance-wise ( P = .07). Primary motivations for women who wanted testing were the desire to know if they have FRAX, and wanting to determine if FRAX is the cause of their ovarian dysfunction. The primary decision factor for those declining testing was unwillingness to pay out-of-pocket (75%). Conclusion Women with ovarian dysfunction are interested in FRAX testing. Cost, confidentiality, and the implications for relatives are their key concerns.

Objective The purpose of this study was to determine if a suboptimal cytoreduction can be predicted preoperatively in women with advanced ovarian cancer. Study design All women with stage III/IV epithelial ovarian cancer treated with initial surgery at our hospital between January 1, 1995 and January 1, 2003 were eligible; 56 patients met inclusion criteria and underwent retrospective chart review. Statistical analysis was performed using SPSS. Results Twenty-nine women (52%) had optimal cytoreduction (OC), and 27 (48%) had suboptimal cytoreduction (SC). Women in the SC group had higher median CA-125 values at surgery (954 SC vs 597 OC, P = .07). Three sites of disease on preoperative CT were reported more frequently in the SC patients; omentum (P = .007), parietal peritoneum (P = .096), and ascites (P = .093). Conclusion A suboptimal cytoreduction confers no survival advantage to women with advanced ovarian cancer. Thus, these patients may be the best candidates for initial chemotherapy, and identifying them preoperatively becomes important.

Given the demonstrated utility of human papilloma virus DNA triage in the management of atypical squamous cells of undetermined significance, this study sought to evaluate the potential role of human papilloma virus DNA testing in the evaluation and management of cytological atypical glandular cells.Following institutional review board approval, 28 women presenting with cytological atypical glandular cells underwent repeat thin-prep cytology, Hybrid Capture 2 human papilloma virus DNA testing, colposcopic evaluation, Fisher electrosurgical conization, and endometrial sampling. Human papilloma virus test results in each patient were then correlated with histologic lesions, if present.Sixteen of the 28 study patients had pathologic lesions (11/28 high-grade squamous intraepithelial lesion, 3/28 low-grade squamous intraepithelial lesion, 1/28 adenocarcinoma in situ, 1/28 simple endometrial hyperplasia). Human papilloma virus DNA testing was available in 24 of 28 subjects (86%). The sensitivity of human papilloma virus positivity to predict the presence of cervical intraepithelial neoplasia was 100% (confidence interval 77% to 100%), specificity 64% (confidence interval 35% to 85%), positive predictive value 76%, and negative predictive value 100%. Women who tested human papilloma virus positive were 12 times more likely to have cervical intraepithelial neoplasia than women who were human papilloma virus negative (Fisher P.001). Human papilloma virus positivity was not predictive of endometrial pathology; women who were human papilloma virus positive were less likely to have endometrial pathology than were women who were human papilloma virus negative (risk ratio 1.6, 95% confidence interval 0.01-1.7).Atypical glandular cells can represent a variety of lesions. The majority of the lesions will be squamous intraepithelial lesions of the cervix (50%), with high-grade squamous intraepithelial lesion present in 40% of subjects. Human papilloma virus DNA testing is a sensitive test for the presence of squamous intraepithelial lesion, with excellent negative predictive value for the absence of squamous intraepithelial lesion. The results of this study suggest human papilloma virus DNA testing might be an effective screening test in the initial evaluation and management of cytological atypical glandular cells.

Objective: To examine the prevalence and correlates of self-reported urogenital symptoms (dryness, irritation or itching, discharge, dysuria) among postmenopausal women aged 50–79. Design: A cross-sectional analysis based on n = 98,705 women enrolled in the US-based Women’s Health Initiative observational study and clinical trials. Urogenital symptoms, symptom severity (mild, moderate, severe), and all covariates were self-reported through questionnaires at enrollment. Prevalence rates of each urogenital symptom were examined and logistic regression was used to identify potential correlates. Results: Prevalence rates for each symptom were: dryness, 27.0%; irritation or itching, 18.6%; discharge, 11.1%; and dysuria, 5.2%. Four factors were correlated with two or more symptoms: Hispanic ethnicity (adjusted odds ratio (AOR) = 2.1–3.1 versus white women across all symptoms), obesity (AOR = 2.2 severe discharge versus none, AOR = 3.6 severe irritation/itching versus none), treated diabetes (pills or shots) compared to no diabetes (AOR = 2.4 severe dysuria versus none, AOR = 3.2 severe irritation/itching versus none), and vaginal cream HRT/ERT compared to those who never used HRT/ERT (AOR = 4.4 severe dryness versus none, AOR = 4.6 severe irritation/itching versus none). Factors not associated with the symptoms included sexual activity, age, years since menopause, current smoking, marital status, gravidity, and natural versus surgical menopause. Conclusions: This is the first report to document urogenital symptoms by race/ethnicity among an exclusively postmenopausal population. We found an elevated prevalence of urogenital symptoms among women who are Hispanic, obese, and/or diabetic. Confirmation of our findings in these subgroups, and, if confirmed, analysis on why these populations are at greater risk, are areas for future research.

OBJECTIVE: Prospectively validate an antenatal bacterial vaginosis (BV) risk score at two public health department obstetrics clinics. STUDY DESIGN: Women (n=409) entering prenatal care received a BV risk score (range 0 to 16) at their first visit and at 24 to 28 weeks' gestation. BV was measured with Gram-stained vaginal smears. Normal discharge was used as a surrogate for being asymptomatic. RESULTS: Approximately half of the women scored ≥3 at each assessment. In total 29% had true BV at the first assessment (13% at the second assessment). The BV risk score (≥3) had 91% sensitivity and 63% specificity, and the BV risk score (≥5) had 88% sensitivity and 76% specificity. Among true cases, 42% were asymptomatic, of which 77% had risk scores ≥3. All symptomatic BV cases had risk scores ≥3. CONCLUSION: In practice, the risk score identified both asymptomatic and symptomatic cases. Asymptomatic women are of particular interest because they are not screened for BV under current practice guidelines.

Published investigations of the association between urinary tract infection (UTI) and preterm delivery used logistic regression or chi-squared tests. Because both exposure and outcome are time dependent, these methods were not optimal and did not account for person-time under observation, potentially an important feature given the variability of women's entry to prenatal care as well as of gestational lengths. Previous researchers probably classified as exposed some women whose UTI occurred after their pregnancies exceeded 37 weeks. We applied the previous analytical methods to 1990-93 births from two Durham, NC, USA, hospitals (n = 4053) and demonstrate survival methods as an alternative. Two logistic regression models were fitted with differing exposure definitions: model 1 in which exposed = UTI diagnosed after 20 weeks' gestation; and model 2 in which exposed = UTI diagnosed between 20 weeks' and 37 weeks' gestation. Model 3 used proportional hazards regression with person-time after 20 weeks and before UTI diagnosis as unexposed, and person-time after diagnosis as exposed. Models were fit with and without five time-constant potential confounders. Model 1 yielded an adjusted odds ratio (OR) of 0.8 [95% confidence interval (CI) 0.5, 1.2], and model 2, which did not include UTI diagnoses after 37 weeks, an adjusted OR of 0.9 [95% CI 0.6, 1.4]. The Cox model hazard ratio (HR) for preterm delivery was 1.1 (adjusted) [95% CI 0.7, 1.7]. As these results indicated some bias, but not remarkable differences, we conducted a sensitivity analysis using 100 samples of 80% of the original data set, with replacement to determine how large the differences might be in other, similar data sets. The Cox method consistently produced higher effect estimates than either logistic model. The two samples with the greatest differences between the Cox and logistic model estimates yielded an OR of 1.47 [95% CI 0.95, 2.29] for model 1 vs. HR of 2.06 [95% CI 1.39, 3.06] for model 3, and an OR of 1.41 [95% CI 0.88, 2.25] for model 2 vs. HR of 1.79 [95% CI 1.17, 2.71] for model 3 respectively. Previous published results on UTI and preterm delivery require cautious interpretation. Data on UTI timing should be gathered to allow appropriate analyses; survival methods account for person-time under observation and ensure that studied exposures precede effects.

The strongest association between FMR1 and the ovary in humans is the increased risk of premature ovarian failure (POF) in women who carry the premutation level of CGG repeats (55–199 CGGs). Research on the FMR1 gene has extended to other endpoints of relevance in the OB/GYN setting for women, including infertility and ovarian hormones. After reviewing the nomenclature changes that have occurred in recent years, this article reviews the evidence linking the length of the FMR1 repeat length to fertility and ovarian hormones (follicle stimulating hormone and anti-mullerian hormone as the primary methods to assess ovarian reserve in clinical settings). The literature is inconsistent on the association between the FMR1 trinucleotide repeat length and infertility. Elevated levels of follicle stimulating hormone have been found in women who carry the premutation; however the literature on the relationship between anti-mullerian hormone and the CGG repeat length are too disparate in design to make a summary statement. This article considers the implications of two transgenic mouse models (FXPM 130R and YAC90R) for theories on pathogenesis related to ovarian endpoints. Given the current screening/testing recommendations for reproductive age females and the variability of screening protocols in clinics, future research is recommended on pretest and posttest genetic counseling needs. Future research is also needed on ovarian health measurements across a range of CGG repeat lengths in order to interpret FMR1 test results in reproductive age women; the inconsistencies in the literature make it quite challenging to advise women on their risks related to FMR1 repeat length.

Background There is a need to identify an inexpensive, effective method to prevent postoperative adhesion formation. The objective of this study was to create a novel model for studying omentum as a pelvic adhesion barrier. Randomized, prospective, controlled surgical intervention with serial follow-up in 16 female rabbits at a University-based Center for Comparative Medicine. Interventions included bilateral hysterotomy incision and repair. The left hysterotomy was randomized into coverage with an omental flap or graft; the right hysterotomy remained uncovered. Adhesions were scored via laparoscopy on postoperative days 2, 4, 8, and 12; postmortem evaluation and scoring took place on postoperative day 16. Statistical tests consisted of Kappa tests of agreement between adhesion scorers and Kruskal-Wallis nonparametric tests for the comparison of adhesion scores by intervention arm and by uterine horn. Results All omental flaps and grafts survived. The only significant difference in mean adhesion scores was seen in non-hysterotomy-associated adhesions, where grafts had a lower score than flaps (p = 0.03). Conclusions Survival of all omental flaps and grafts demonstrates that this is a practical model for studying omentum as a pelvic adhesion barrier. Determining the efficacy of omentum as a pelvic adhesion barrier will require further investigation.

The purpose of this study was to investigate the association between bacterial vaginosis (BV) and cervical dilation and effacement, as measures of impending preterm delivery. The Pregnancy, Infection, and Nutrition Study collected genital tract specimens and documented cervical change from 807 eligible women between 24 and 29 weeks' gestation. BV was assessed with Nugent-scored vaginal smears, and analyzed in relation to cervical measurements. At 24-29 weeks' gestation

Objective: To investigate the relationship between fetal fibronectin and bacterial vaginosis, which are associated with an increased risk for preterm delivery. Methods: Researchers for the Pregnancy, Infection and Nutrition Study, a cohort study of pregnant women at three central North Carolina sites, collected genital tract specimens from all enrolled women between 24 and 29 weeks’ gestation. Among women with last menstrual periods between March 10, 1995, and August 15, 1996, 868 pregnancies were eligible for this analysis. Fetal fibronectin was assessed by a dipstick immunoassay kit. Bacterial vaginosis was evaluated by Nugent-scored, Gram-stained vaginal smears (scores of 7–10 considered positive). Results: Overall, 6.3% of women had positive fetal fibronectin test results, and 18.8% had bacterial vaginosis. The unadjusted relative risk (RR) of fetal fibronectin-positivity comparing women with bacterial vaginosis to those without bacterial vaginosis was 1.6 (95% confidence interval [CI] 1.1, 2.5). Using multiple logistic regression to adjust for race, maternal age, parity, and location of care, women who had bacterial vaginosis and smoked at the time of recruitment were at substantially increased risk of fetal fibronectin-positivity (RR 7.8, 95% CI 2.2, 27.8) compared with smokers without bacterial vaginosis. Among nonsmokers, bacterial vaginosis was not associated with fetal fibronectin-positivity (RR 1.0, 95% CI 0.4, 2.4). These results were essentially unchanged after adding the requirement of vaginal pH exceeding 4.5 to the bacterial vaginosis definition. Conclusion: Fetal fibronectin was associated positively with bacterial vaginosis, but only among women who smoked. These results might provide clues as to the biologic relationship between smoking, infection, and preterm delivery.

Although many women reduce their caffeine consumption once they known they are pregnant, 70-80% of pregnant women still consume caffeine. To evaluate the relation between caffeine consumption and preterm delivery, a case-control study was conducted to identify all preterm (< 37 weeks gestation) infants born to women in selected North Carolina counties from September 1988 through April 1991. Randomly selected full-term, normal-weight livebirths (matched by race and hospital) served as controls. The study population consisted of 408 cases and 490 controls. Telephone interviews with participants assessed the consumption of caffeinated coffee, tea, cola soft drinks, and noncola caffeinated soft drinks, with caffeine consumption measured by the number of daily servings of each beverage and the total milligrams of caffeine. Third-trimester caffeine consumption from all beverages combined showed a nonsignificant inverse association with preterm delivery. Both first- and second-trimester consumption of 1-150 mg/day were associated with a modestly increased risk of preterm delivery, while no association was found at higher consumption levels. Overall, these results do not support an association between caffeinated beverage consumption and preterm delivery, as is true in most previous studies.

Objective To measure the level of distress and its relationship with other psychologic factors in women with diminished ovarian reserve (DOR) who participated in a fragile X genetics study. Design Longitudinal data analyzed with structural equation modeling. Setting Four U.S. private and academic fertility centers. Patient(s) Sixty-two infertile patients with DOR. Intervention(s) None. Main Outcome Measure(s) Fertility Problem Inventory, Coping Scale for Infertile Couples, Rosenberg Self-Esteem, Health Orientation Scale. Result(s) Nineteen percent had low fertility distress, 56% had average fertility distress, and 24% had high fertility distress. Thirty-six percent self-reported a "favorable" or "very favorable" emotional response to potentially being a fragile X carrier (termed "emotions"), 53% were "ambivalent," and 11% had an unfavorable reaction. Three months after learning that they were not a carrier, these percentages were 91%, 9%, and 0%, respectively. Emotions at this second time point were significantly more positive than at pretesting. At baseline, higher self-esteem was a significant predictor of reduced fertility distress both directly and indirectly through emotions. Fertility distress was not associated with coping. Self-esteem, fertility distress, pretesting emotions, and coping were unrelated to posttesting emotions. Conclusion(s) The potential of having an explanation for one's DOR condition may have a beneficial impact on women's psychologic states during the process of genetic testing, and this appeared to be especially true for women with higher self-esteem. Psychologic interventions targeted to women with low self-esteem may reduce distress and improve reactions to genetic testing.

The objective of the study was to examine the effect of center characteristics on educational experiences and female pelvic medicine knowledge changes in third-year students at 6 medical schools.: In this secondary analysis of data acquired during a prospective, multicenter study conducted from May 2008 through June 2009, preclerkship and postclerkship third-year medical students scored their knowledge of 12 female pelvic medicine topics and 4 office procedures (knowledge scores [KSs]). Postclerkship, students also reported the number and type of learning experiences they had encountered. Participating investigators provided data on length of clerkship, number of residents, number of fellowship-trained urogynecologists, presence of a fellowship program, clerkship grading system type, presence of a urogynecology clerkship rotation, and presence of a urogynecology lecture. Analyses used Wilcoxon tests/Spearman correlation, with an α = 0.05.: Paired preclerkship and postclerkship survey data were available for 323 students. Increased numbers of learning experiences were positively associated with number of clerkship weeks (rs = 0.22, P0.001), presence of a urogynecology rotation (P = 0.03), and urogynecology lecture (P0.001). Knowledge scores were positively associated with the number of fellowship-trained urogynecology faculty (rs = 0.17, P = 0.002) and grading system (letter gradespass/fail) (P0.001). Knowledge scores were negatively associated with increasing numbers of residents (rs = -0.29, P0.001) and presence of a urogynecology fellowship program (P0.001). The center characteristics of fellowship program and number of residents were highly correlated (rs = 0.74, P0.001); thus, multivariate modeling was not performed.: The presence of fellowship-trained faculty, urogynecology rotation, longer duration of clerkship, and urogynecology lecture were positively correlated with higher subjective KSs. The inverse association of KS with increased resident number and presence of fellowship was an unexpected finding.

OBJECTIVE : The objective of this study was to describe self-assessed student knowledge of female pelvic medicine (FPM) during the OBGYN clerkship. METHODS : Students at 6 sites scored their knowledge of 12 FPM topics and 4 procedures both before and after their clerkship. Analysis included Wilcoxon tests, Spearman correlation, and univariate and multivariate models. RESULTS : A total of 323 students completed paired surveys. Mean knowledge scores (KSs) across FPM topics (1.40 ± 0.12; 95% confidence interval) and procedures (0.77 ± 0.08) increased significantly, with larger increases for topics (P < 0.001). Topic and procedure KSs were correlated (rs = 0.32, P < 0.0001). Mean KSs were significantly related to number and number of types of learning experiences (r = 0.13 and 0.08, both P < 0.001). Learning through text and inpatient encounters had independent effects on KS change in multivariate analysis (P = 0.01 and 0.007). CONCLUSIONS : Students reported increased knowledge although less for procedures than for topics. Text and inpatient learning independently increased students' self-assessed change in knowledge.