Kurt Barnhart

Hospital of the University of Pennsylvania, Filadelfia, Pennsylvania, United States

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Publications (173)723.84 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel. We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6. Study outcomes included pregnancy probability, safety, acceptability, and fit. Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels. Most (439/450 [98%]) women could be fitted with the single-size diaphragm. A total of 421 of 450 (94%) provided follow-up. The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95% confidence intervals (CIs) of 10.4 (6.9-14.0) for all users and 9.6 (5.5-13.6) and 12.5 (5.4-19.5) with acid-buffering gel and nonoxynol-9, respectively. Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ([rounded] difference 0.7, 95% CI -3.6 to 4.9). Approximately half (51%) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis. Most (282/342 [82%]) liked the diaphragm. Results suggest that if provided by a clinician, 94% (95% CI 92-96%) could insert, correctly position, and remove the diaphragm. The single-size diaphragm was safe, as effective as a standard diaphragm, and acceptable when used with contraceptive gel. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00578877. LEVEL OF EVIDENCE:: II.
    Obstetrics and Gynecology 03/2015; DOI:10.1097/AOG.0000000000000721 · 4.37 Impact Factor
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    ABSTRACT: To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Randomized, prospective clinical trial. Multicenter university-based clinical practices. A total of 900 couples with unexplained infertility. Collection of baseline demographics, blood samples, and ultrasonographic assessments. Demographic, laboratory, imaging, and survey characteristics. Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment. NCT 01044862. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
    Fertility and Sterility 02/2015; DOI:10.1016/j.fertnstert.2014.12.130 · 4.30 Impact Factor
  • Kurt T Barnhart
    American Journal of Obstetrics and Gynecology 01/2015; 212(1):4-6. DOI:10.1016/j.ajog.2014.07.042 · 3.97 Impact Factor
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    ABSTRACT: Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.
    Fertility and Sterility 09/2014; 102(4). DOI:10.1093/humrep/deu218 · 4.30 Impact Factor
  • Kurt T. Barnhart
    Fertility and Sterility 09/2014; 102(4). DOI:10.1016/j.fertnstert.2014.08.026 · 4.30 Impact Factor
  • Fertility and Sterility 09/2014; 102(3):e48-e49. DOI:10.1016/j.fertnstert.2014.07.170 · 4.30 Impact Factor
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    ABSTRACT: Background Clomiphene is the current first-line infertility treatment in women with the polycystic ovary syndrome, but aromatase inhibitors, including letrozole, might result in better pregnancy outcomes. Methods In this double-blind, multicenter trial, we randomly assigned 750 women, in a 1:1 ratio, to receive letrozole or clomiphene for up to five treatment cycles, with visits to determine ovulation and pregnancy, followed by tracking of pregnancies. The polycystic ovary syndrome was defined according to modified Rotterdam criteria (anovulation with either hyperandrogenism or polycystic ovaries). Participants were 18 to 40 years of age, had at least one patent fallopian tube and a normal uterine cavity, and had a male partner with a sperm concentration of at least 14 million per milliliter; the women and their partners agreed to have regular intercourse with the intent of conception during the study. The primary outcome was live birth during the treatment period. Results Women who received letrozole had more cumulative live births than those who received clomiphene (103 of 374 [27.5%] vs. 72 of 376 [19.1%], P=0.007; rate ratio for live birth, 1.44; 95% confidence interval, 1.10 to 1.87) without significant differences in overall congenital anomalies, though there were four major congenital anomalies in the letrozole group versus one in the clomiphene group (P=0.65). The cumulative ovulation rate was higher with letrozole than with clomiphene (834 of 1352 treatment cycles [61.7%] vs. 688 of 1425 treatment cycles [48.3%], P<0.001). There were no significant between-group differences in pregnancy loss (49 of 154 pregnancies in the letrozole group [31.8%] and 30 of 103 pregnancies in the clomiphene group [29.1%]) or twin pregnancy (3.4% and 7.4%, respectively). Clomiphene was associated with a higher incidence of hot flushes, and letrozole was associated with higher incidences of fatigue and dizziness. Rates of other adverse events were similar in the two treatment groups. Conclusions As compared with clomiphene, letrozole was associated with higher live-birth and ovulation rates among infertile women with the polycystic ovary syndrome. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT00719186 .).
    New England Journal of Medicine 07/2014; 371(2):119-129. DOI:10.1056/NEJMoa1313517 · 54.42 Impact Factor
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    ABSTRACT: Women with prior ectopic pregnancy (EP) have an increased failure rate when treated with single-dose methotrexate (MTX) for subsequent EP. We sought to determine whether previous EP remained a risk factor for failure when using the two-dose MTX protocol.
  • Kurt T. Barnhart
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    ABSTRACT: The rationale to freeze all embryos to avoid transfer into a supraphysiologic environment to improve safety and efficacy is compelling, but not yet proven. How do we decide?
    Fertility and Sterility 07/2014; 102(1). DOI:10.1016/j.fertnstert.2014.05.024 · 4.30 Impact Factor
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    ABSTRACT: Antithrombin (AT) is a 65 kDa glycoprotein belonging to a group of inhibitory factors known as serpins (serine protease inhibitors). It plays a critical role in the inhibition of coagulation and inflammation processes within the environment of the vascular endothelium. Inadequate levels of functional AT in plasma results in an increased risk of thrombotic events, both venous and arterial. AT deficiency can be inherited or acquired. Congenital AT deficiency is the most severe inherited thrombophilic condition with an odds ratio of 20 for the increased risk of venous thrombosis. Acquired AT deficiency occurs in a variety of physiologic and pathologic medical conditions with similar risks of increased thrombosis. In this article, we review clinical settings characterized by an acquired AT deficiency largely or partly subsequent to protein microvascular leakage. Other different mechanisms of AT depletion are implied in some clinical conditions together with endothelial loss, and, therefore, outlined. In addition, we provide a description of the current knowledge on the specific mechanisms underlying endothelial AT leakage and on the consequences of this protein decrease, specifically looking at thrombosis. We identify potential directions of research that might prove useful in patients with acquired AT deficiency.
    Thrombosis Research 06/2014; 133(6). DOI:10.1016/j.thromres.2014.02.014 · 2.43 Impact Factor
  • Kurt T Barnhart
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    ABSTRACT: Well-designed and -conducted clinical trials are needed to further advance the field for reproductive medicine. However, current reporting of outcomes of trials is ambiguous and disparate. In this review it is offered that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed, and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a prespecified number of cycles, or a period of time). Pregnancy loss should be specified, and the denominator should be those who conceived. Although live birth is the primary outcome, complications should be defined and reported, including multiple births and other objective markers, such as preterm delivery, small-for-gestational age, or stillbirth.
    Fertility and sterility 05/2014; 101(5):1205-1208. DOI:10.1016/j.fertnstert.2014.03.026 · 4.30 Impact Factor
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    ABSTRACT: Background Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. Methods In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. Findings 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60·7% after salpingotomy and 56·2% after salpingectomy (fecundity rate ratio 1·06, 95% CI 0·81–1·38; log-rank p=0·678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15·0, 2·0–113·4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1·6, 0·8–3·3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. Interpretation In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy. Funding Netherlands Organisation for Health Research and Development (ZonMW), Region Västra Götaland Health & Medical Care Committee.
    The Lancet 02/2014; DOI:10.1016/S0140-6736(14)60123-9 · 39.21 Impact Factor
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    ABSTRACT: Women who present with first-trimester vaginal bleeding often undergo evaluation for ectopic pregnancy (EP). After a confirmatory pregnancy test, women who show no ultrasound evidence of an intrauterine pregnancy or an EP are said to have a pregnancy of unknown location (PUL). It is estimated that 7% to 20% of women who initially have a PUL will have a final diagnosis of EP. Practitioners evaluating a PUL often face a difficult management decision: premature intervention can result in termination of a viable pregnancy, but delayed intervention may lead to rupture of an untreated EP. In women with a PUL, 2 serial human chorionic gonadotrophin (hCG) measurements within the first 48 hours after initial presentation are commonly used to help predict the final diagnosis. Because initial outcome predictions based on 2 hCG values are often incorrect, many practitioners have patients with a PUL return 2 to 5 days after the second hCG measurement for an additional hCG evaluation. At present, there is no standard of care regarding time and frequency of hCG testing in women with a PUL. The aim of this retrospective multicenter cohort study was to determine whether additional hCG values beyond the first 48 hours can improve diagnostic accuracy in women with a PUL. A total of 646 women with a PUL were recruited over 2 years at 3 academic centers in the United States; 146 of these women were ultimately diagnosed with EP. Participants presented to the emergency room with pain or bleeding in the first trimester, had a PUL on ultrasound, at least 2 hCG values, and a definitive final diagnosis after follow-up. Using standard clinical prediction rules, addition of a third hCG evaluation on day 4 after initial presentation significantly improved the accuracy of initial prediction from the first 2 hCG values by 9.3% (P = 0.015). Similarly, adding a third value on day 7 significantly improved the predicted diagnosis by 6.7% (P = 0.031). Assessing 4 hCG values (days 0, 2, 4, and 7) compared with 3 values (days 0, 2, and 4) produced a small insignificant improvement (1.3%) in the predicted diagnosis. The data show that measurement of hCG values 48 hours (2 days) apart does not optimize the accuracy of diagnosis in women with a PUL. Adding a third hCG measurement on day 4 or 7 significantly improves the predicted diagnosis for 1 in 15 women. Although these data provide useful information for the prediction of outcomes for women with a symptomatic first-trimester PUL, the results may not be generalizable to all pregnant women.
    Obstetrical and Gynecological Survey 01/2014; 69(7):399-400. DOI:10.1097/01.ogx.0000452704.04922.42 · 2.36 Impact Factor
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    ABSTRACT: Objective To summarize baseline characteristics from a large multicenter infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the United States. Patient(s) Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. Intervention(s) None. Main Outcome Measure(s) Historic, biometric, biochemical, and questionnaire parameters. Result(s) Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. Conclusion(s) The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. Clinical Trial Registration Number NCT00719186.
    Fertility and Sterility 01/2014; 101(1):258–269.e8. DOI:10.1016/j.fertnstert.2013.08.056 · 4.30 Impact Factor
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    ABSTRACT: Are there improvements in the accuracy of prediction of ectopic pregnancy (EP) in women with early symptomatic pregnancy using human chorionic gonadotrophin (hCG) curves when clinicians consider visits beyond the first 48 h after initial presentation? Two hCG values, measured 48 h (2 days) apart, are often not sufficient to accurately predict the outcome of a woman with a pregnancy of unknown location (PUL), but adding a third visit on Day 4 or 7 significantly improved the prediction for 1 in 15 women. The use of serial hCG values is commonly used to aid in the prediction of the final diagnosis in women with a PUL. Initial outcome predictions based on two hCG values may often be incorrect. This retrospective multicenter cohort study included 646 women with a PUL, recruited over 2 years. Of these women, 146 were ultimately diagnosed with EP. Women presenting to the emergency room with first trimester pain or bleeding, with a PUL, at least 2 hCG values and a definitive final diagnosis from the University of Pennsylvania, University of Miami and University of Southern California, were recruited from 2007 to 2009. Using currently recommended prediction rules, adding a third hCG evaluation on Day 4 after initial presentation significantly improved the accuracy of initial prediction from the first two values (48 h apart, or Day 2) by 9.3% (P = 0.015). Adding a third value on Day 7 improved prediction significantly by 6.7% (P = 0.031), compared with prediction based on first two values. The improvement in prediction by assessing four hCG values (Days 0, 2, 4 and 7) compared with three values (Days 0, 2 and 4) was 1.3% and not statistically significant. Missing data imputation likely biased results toward the null; predicted outcomes may not match those made by clinicians; and the study does not predict intrauterine pregnancy and spontaneous miscarriage separately. This study provides useful information for the prediction of outcomes for women with a symptomatic first trimester pregnancy of unknown location, but may not be generalizable to all pregnant women. Supported by NIH grant numbers R01-HD036455 to Dr Barnhart and Dr Sammel, K24HD060687 to Dr Barnhart, and 5T32MH065218 to Ms. Zee. The authors have no conflicts of interest to declare.
    Human Reproduction 12/2013; 29(3). DOI:10.1093/humrep/det450 · 4.59 Impact Factor
  • Kurt T Barnhart
    Fertility and sterility 11/2013; 101(1). DOI:10.1016/j.fertnstert.2013.11.012 · 4.30 Impact Factor
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    ABSTRACT: BACKGROUND At present, it is unclear which treatment strategy is best for couples with unexplained or mild male subfertility. We hypothesized that the prognostic profile influences the effectiveness of assisted conception. We addressed this issue by analysing individual patient data (IPD) from randomized controlled trials (RCTs).METHODS We performed an IPD analysis of published RCTs on treatment strategies for subfertile couples. Eligible studies were identified from Cochrane systematic reviews and we also searched Medline and EMBASE. The authors of RCTs that compared expectant management (EM), intracervical insemination (ICI), intrauterine insemination (IUI), all three with or without controlled ovarian stimulation (COS) and IVF in couples with unexplained or male subfertility, and had reported live birth or ongoing pregnancy as an outcome measure, were invited to share their data. For each individual patient the chance of natural conception was calculated with a validated prognostic model. We constructed prognosis-by-treatment curves and tested whether there was a significant interaction between treatment and prognosis.RESULTSWe acquired data from 8 RCTs, including 2550 couples. In three studies (n = 954) the more invasive treatment strategies tended to be less effective in couples with a high chance of natural conception but this difference did not reach statistical significance (P-value for interaction between prognosis and treatment outcome were 0.71, 0.31 and 0.19). In one study (n = 932 couples) the strategies with COS (ICI and IUI) led to higher pregnancy rates than unstimulated strategies (ICI 8% versus 15%, IUI 13% versus 22%), regardless of prognosis (P-value for interaction in all comparisons >0.5), but at the expense of a high twin rate in the COS strategies (ICI 6% versus 23% and IUI 3% versus 30%, respectively). In two studies (n = 373 couples), the more invasive treatment strategies tended to be more effective in couples with a good prognosis but this difference did not reach statistical significance (P-value for interaction: 0.38 and 0.68). In one study (n = 253 couples) the differential effect of prognosis on treatment effect was limited (P-value for interaction 0.52), perhaps because prognosis was incorporated in the inclusion criteria. The only study that compared EM with IVF included 38 couples, too small for a precise estimate.CONCLUSIONS In this IPD analysis of couples with unexplained or male subfertility, we did not find a large differential effect of prognosis on the effectiveness of fertility treatment with IUI, COS or IVF.
    Human Reproduction Update 10/2013; DOI:10.1093/humupd/dmt035 · 8.66 Impact Factor
  • Fertility and Sterility 09/2013; 100(3):S21. DOI:10.1016/j.fertnstert.2013.07.188 · 4.30 Impact Factor
  • Fertility and Sterility 09/2013; 100(3):S513-S514. DOI:10.1016/j.fertnstert.2013.07.229 · 4.30 Impact Factor
  • Fertility and Sterility 09/2013; 100(3):S11. DOI:10.1016/j.fertnstert.2013.07.156 · 4.30 Impact Factor

Publication Stats

2k Citations
723.84 Total Impact Points


  • 1994–2015
    • Hospital of the University of Pennsylvania
      • • Department of Obstetrics and Gynecology
      • • Department of Medicine
      Filadelfia, Pennsylvania, United States
  • 1999–2013
    • University of Pennsylvania
      • • Department of Obstetrics and Gynecology
      • • Center for Clinical Epidemiology and Biostatistics
      Filadelfia, Pennsylvania, United States
    • William Penn University
      Filadelfia, Pennsylvania, United States
  • 2011
    • University of North Carolina at Chapel Hill
      • Department of Obstetrics and Gynecology
      Chapel Hill, NC, United States
  • 2008
    • Boston University
      Boston, Massachusetts, United States
  • 2004–2006
    • Columbia University
      • Department of Obstetrics and Gynecology
      New York, New York, United States
    • University of Louisville
      Louisville, Kentucky, United States
  • 2002
    • Pennsylvania Medical Society
      Filadelfia, Pennsylvania, United States