Richard S Legro

Penn State Hershey Medical Center and Penn State College of Medicine, Hershey, Pennsylvania, United States

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Publications (257)1250.92 Total impact

  • Richard S Legro
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    ABSTRACT: This Views and Reviews article examines FDA-approved uses of prescription drugs, as well as common off-label uses of drugs for several disorders that are frequently seen in reproductive medicine. Off-label drug use is ubiquitous in reproductive medicine, a fact that may be related to the disincentives to formally study these drugs in a potentially vulnerable population (i.e., pregnant women). It behooves clinicians to discuss with patients the risk-benefit ratio of treatment, and whether a treatment is FDA-approved for that condition. Researchers, seeking better data on effects of these drugs, may find fodder for future clinical studies in these articles. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
    Fertility and sterility. 03/2015; 103(3):581-2.
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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;
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    ABSTRACT: Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese. Eighty six (86) women with body mass index ≥25kg/m(2), including 31 women with PCOS, have been randomized to 8weeks of MBSR or health education control, and followed for 16weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. Copyright © 2015 Elsevier Inc. All rights reserved.
    Contemporary Clinical Trials 02/2015; · 1.99 Impact Factor
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    ABSTRACT: Polycystic ovary syndrome (PCOS) is a common endocrinopathy characterized by increased ovarian androgen biosynthesis, anovulation, and infertility. PCOS has a strong heritable component based on familial clustering and twin studies. Genome-wide association studies (GWAS) identified several PCOS candidate loci including LHCGR, FSHR, ZNF217, YAP1, INSR, RAB5B, and C9orf3. We review the functional roles of strong PCOS candidate loci focusing on FSHR, LHCGR, INSR, and DENND1A. We propose that these candidates comprise a hierarchical signaling network by which DENND1A, LHCGR, INSR, RAB5B, adapter proteins, and associated downstream signaling cascades converge to regulate theca cell androgen biosynthesis. Future elucidation of the functional gene networks predicted by the PCOS GWAS will result in new diagnostic and therapeutic approaches for women with PCOS. Copyright © 2014 Elsevier Ltd. All rights reserved.
    Trends in Endocrinology and Metabolism 01/2015; · 8.87 Impact Factor
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    ABSTRACT: Context: Although inflammation is clearly associated with obesity, diabetes, and insulin resistance, the role of chronic inflammation in the etiology of PCOS is unclear. Objective: To determine whether chronic inflammation plays a causal role in the etiology of PCOS, we tested for association between PCOS and genetic markers mapping to 80 members of the inflammatory pathway. Design: Case-control association study. Setting: Academic medical center. Patients or Participants: 905 index cases with PCOS and 955 control women (108 intensively-phenotyped subjects with normal androgen levels and regular menses and 847 minimally-phenotyped subjects with regular menses and no history of PCOS). Interventions: Subjects were genotyped at SNPs mapping to 80 inflammatory genes. Logistic regression was used to test for association between 822 SNPs and PCOS after adjusting for population stratification, BMI and/or age. In the index cases, we also tested for association with 11 quantitative traits (BMI, testosterone, fasting insulin, fasting glucose, 2-hour post-challenge glucose, LH, FSH, total cholesterol, HDL, LDL and triglyceride levels). Main Outcome Measures: Evidence for association with PCOS and with 11 quantitative traits. Results: Nominally significant evidence for association was observed with MAP3K7, IKBKG, TNFRS11A, AKT2, IL6R and IRF1, but none remained statistically significant after adjustment for multiple testing. Conclusions: Genetic variation in the inflammatory pathway is not a major contributor to the etiology of PCOS or related quantitative traits in women with PCOS.
    The Journal of Clinical Endocrinology and Metabolism 12/2014; · 6.31 Impact Factor
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  • Richard S Legro
    Seminars in Reproductive Medicine 11/2014; 32(6):417-418. · 3.21 Impact Factor
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    ABSTRACT: The aim of this prospective cohort study was to determine the time-course in androgen and semen parameters in men after weight loss associated with bariatric surgery. Six men aged 18–40 years, meeting National Institutes of Health bariatric surgery guidelines, were followed between 2005 and 2008. Study visits took place at baseline, then 1, 3, 6 and 12 months after surgery. All men underwent Roux-en-y gastric bypass (RYGB). At each visit, biometric, questionnaire, serum, and urinary specimens and seman analysis were collected. Urinary integrated total testosterone levels increased significantly (P < 0.0001) by 3 months after surgery, and remained elevated throughout the study. Circulating testosterone levels were also higher at 1 and 6 months after surgery, compared with baseline. Serum sex hormone-binding globulin levels were significantly elevated at all time points after surgery (P < 0.01 to P = 0.02). After RYGB surgery, no significant changes occurred in urinary oestrogen metabolites (oestrone 3-glucuronide), serum oestradiol levels, serial semen parameters or male sexual function by questionnaire. A threshold of weight loss is necessary to improve male reproductive function by reversing male hypogonadism, manifested as increased testosterone levels. Further serial semen analyses showed normal ranges for most parameters despite massive weight loss.
    Reproductive biomedicine online 11/2014; · 2.68 Impact Factor
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    ABSTRACT: We assessed the impact of energy deficiency on menstrual function using controlled feeding and supervised exercise over four menstrual cycles (1 Baseline and 3 Intervention cycles) in untrained, eumenorrheic women ages 18-30 yrs. Subjects were randomized to either an exercising control (EXCON) or one of three exercising energy deficit (ED) groups i.e., mild (ED1) (-8 ± 2%), moderate (ED2) (-22 ± 3%), or severe (ED3) (-42 ± 3%). Menstrual cycle length and changes in urinary concentrations of estrone-1-glucuronide, pregnanediol glucuronide, and mid-cycle luteinizing hormone were assessed. Thirty-four subjects completed the study. Weight loss occurred in ED1 (- 3.8 ± 0.2 kg), ED2 (- 2.8 ± 0.6 kg), and ED3 (- 2.6 ± 1.1 kg), but was minimal in EXCON (-0.9 ± 0.7 kg). The overall sum of disturbances (luteal phase defects, anovulation, and oligomenorrhea) was greater in ED2 compared to EXCON and greater in ED3 compared to EXCON AND ED1. The average percent energy deficit was the main predictor of the frequency of menstrual disturbances (f = 10.1; β= -0.48; R2=0.23; p=0.003) even when including weight loss in the model. The estimates of the magnitude of energy deficiency associated with menstrual disturbances ranged from -22% (ED2) to -42% (ED3), reflecting an energy deficit of -470 to -810 kcal per day, respectively. This is the first study to demonstrate a dose response relation between the magnitude of energy deficiency and the frequency of exercise-related menstrual disturbances; however, the severity of menstrual disturbances was not dependent on the magnitude of energy deficiency.
    AJP Endocrinology and Metabolism 10/2014; · 4.09 Impact Factor
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    ABSTRACT: Are there abnormalities in gonadotrophin secretion, adrenal steroidogenesis and/or testicular steroidogenesis in brothers of women with polycystic ovary syndrome (PCOS)?
    Human Reproduction 10/2014; · 4.59 Impact Factor
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    ABSTRACT: Do women with polycystic ovary syndrome (PCOS) seeking fertility treatment report smoking accurately and does participation in infertility treatment alter smoking?
    Human reproduction (Oxford, England). 10/2014;
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    ABSTRACT: Context: Two genome wide association studies (GWAS) of PCOS have identified 11 susceptibility loci in Chinese individuals. Some of the risk loci identified in Chinese cohorts, mostly from the first GWAS, have been replicated in Europeans. Replication of the loci from the second GWAS in European cohorts is necessary to determine whether the same variants confer risk for PCOS in multiple ethnicities. Objective: To determine the effects of the Chinese GWAS loci in European-origin individuals. Design: Genetic association study. Setting: Tertiary care academic center. Patients: Eight hundred and forty-five European subjects with PCOS and 845 controls. Interventions: Blood sampling and genotyping. Main Outcome Measure: The association between PCOS and 12 independent single nucleotide polymorphisms (SNPs) mapping to 7 of the Chinese GWAS loci in a European cohort. Results: Variants in DENND1A (P=0.0002), THADA (P=0.035), FSHR (P=0.007) and INSR (P=0.046) were associated with PCOS in Europeans. The genetic risk score, generated for each subject based on the total number of risk alleles, was associated with the diagnosis of PCOS (P<0.0001), and remained associated (P=0.02) even after exclusion of the four variants individually associated with PCOS. Conclusions: At least four of the PCOS susceptibility loci identified in the Chinese GWAS are associated with PCOS in Europeans. The overall genetic burden for PCOS, as demonstrated by the risk score, is also associated with the diagnosis of PCOS in Europeans. The PCOS susceptibility loci identified in the Chinese GWAS are thus likely to play an important role in the etiology of PCOS across ethnicities.
    The Journal of clinical endocrinology and metabolism. 10/2014;
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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.
    Human reproduction (Oxford, England). 09/2014;
  • Fertility and Sterility 09/2014; 102(3):e2. · 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. · 54.42 Impact Factor
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    ABSTRACT: 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.
    Fertility and sterility 06/2014; · 4.30 Impact Factor
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    ABSTRACT: Context: Polycystic ovary syndrome (PCOS) is a highly heritable complex trait. Parents of affected women have reproductive and metabolic phenotypes. Objective: We tested the hypothesis that there are parental effects on the heritability of fasting dysglycemia in women with PCOS. Design and Setting: This was a cross-sectional study at an academic medical center. Participants: Participants included 367 women with PCOS and their parents (1101 total subjects). Main Outcome Measures: We compared maternal and paternal contributions to heritability of fasting dysglycemia and to transmission of the PCOS susceptibility allele of D19S884 within the fibrillin-3 gene (D19S884-A8) on fasting dysglycemia. Results: Fathers had higher fasting glucose levels, prevalence of fasting dysglycemia and proinsulin to insulin molar ratios (P < .0001), a marker of defective insulin processing, compared with mothers. Heritability of fasting dysglycemia was significant in PCOS families (h(2) = 37%, SE = 10%, P = .001). Maternal heritability (h(2) = 51%, SE = 15%, P = .0009) was higher than paternal heritability (h(2) = 23 %, SE = 23%, P = .186) of fasting dysglycemia after adjustment for age and body mass index. Within dysglycemic probands, there was increased maternal compared with paternal transmission of D19S884-A8 (maternal 84% vs paternal 45%, χ(2) = 6.51, P = .011). Conclusions: There was a sex difference in the parental metabolic phenotype with fathers having an increased risk of fasting dysglycemia and evidence for pancreatic β-cell dysfunction compared with mothers. However, only maternal heritability had significant effects on the prevalence of fasting dysglycemia in women with PCOS. Furthermore, there were maternal parent-of-origin effects on transmission of D19S884-A8 probands with fasting dysglycemia. These findings suggest that maternal factors, genetic and perhaps epigenetic, contribute to the metabolic phenotype in affected women.
    Journal of Clinical Endocrinology &amp Metabolism 05/2014; · 6.31 Impact Factor
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    ABSTRACT: Polycystic ovary syndrome (PCOS) patients are at increased risk of pregnancy complications, which may impair pregnancy outcome. Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications. Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer.
    Trials 05/2014; 15(1):154. · 2.12 Impact Factor
  • Richard S Legro, Xiaoke Wu
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    ABSTRACT: Clinical trials in infertility choose from a variety of outcomes including change in some surrogate marker of gamete quality to healthy live birth. Incomplete reporting of outcomes makes it difficult to compare studies and to determine the clinical impact of infertility treatments. In this Views and Reviews, we explore the merits of collecting various outcomes of interest in infertility trials from the vantage point of infertility specialists, an obstetrician, and a pediatrician. These articles support more complete reporting of maternal, paternal, fetal, and infant outcomes from infertility trials to improve patient care and ultimately public health.
    Fertility and sterility 05/2014; 101(5):1201-1202. · 4.30 Impact Factor
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    ABSTRACT: English is increasingly the medical lingua franca. We hypothesized that an intensive journal club model based on articles and questions from obstetrics and gynecology could improve written and spoken comprehension of medical English in a population of Chinese medical professionals. Participants took a three-part baseline examination (multiple choice, 15 questions), written (10-point scale) and oral (12-point scale), to assess medical English comprehension that was repeated at study conclusion. After baseline, students were randomized to either 1) an intensive treatment arm with 24 journal club sessions led by a U.S. medical student over the course of 8 weeks; or 2) a self-study group. Primary outcome measured was the change in score from baseline on the multiple choice examination, adapted from APGO uWISE examinations. Secondary outcomes included change in written and oral scores with grading scales used for respective TOEFL tests. The agreement between the two evaluators had weighted κ scores ranging from 0.57 to 0.71 that are comparable to TOEFL κ scores. Both groups improved the mean number of correct multiple choice responses, but there was no statistically significant difference between groups (P=.16). Compared with self-study, however, an intensive journal club significantly improved written scores (mean change 3.1, 95% confidence interval [CI] 1.1-5.0, P=.003) and oral scores (mean change 1.9, 95% CI 0.1-3.8, P=.04). Although reading journal articles improved the mean medical comprehension of both groups (13% and 7%, respectively), interacting with colleagues and an English-speaking facilitator in an intensive journal club environment may selectively improve both written and speaking capabilities.
    Obstetrics and Gynecology 05/2014; 123 Suppl 1:23S. · 4.37 Impact Factor

Publication Stats

10k Citations
1,250.92 Total Impact Points

Institutions

  • 1997–2015
    • Penn State Hershey Medical Center and Penn State College of Medicine
      • • Obstetrics and Gynecology
      • • Cellular and Molecular Physiology
      Hershey, Pennsylvania, United States
  • 2014
    • Heilongjiang University of Chinese Medicine
      Charbin, Heilongjiang Sheng, China
  • 2000–2014
    • Pennsylvania State University
      University Park, Maryland, United States
  • 2012
    • University of Colorado
      • Department of Obstetrics and Gynecology
      Denver, CO, United States
    • Carolinas Medical Center University
      Charlotte, North Carolina, United States
  • 2011–2012
    • Wayne State University
      • Department of Obstetrics and Gynecology
      Detroit, MI, United States
    • University of Missouri
      • Department of Obstetrics, Gynecology and Women's Health
      Columbia, MO, United States
    • Lehigh Valley Health Network
      Allentown, Pennsylvania, United States
    • University of Vermont
      Burlington, Vermont, United States
  • 2008–2012
    • Meharry Medical College
      • Department of Obstetrics and Gynecology
      Nashville, TN, United States
    • Stanford Medicine
      Stanford, California, United States
    • Rutgers New Jersey Medical School
      • Department of Obstetrics, Gynecology and Women's Health
      Newark, NJ, United States
  • 2003–2012
    • University of Alabama at Birmingham
      • Department of Obstetrics and Gynecology
      Birmingham, Alabama, United States
  • 2009–2011
    • Virginia Commonwealth University
      • • Division of Endocrinology and Metabolism
      • • Department of Obstetrics and Gynecology
      Richmond, VA, United States
    • University of Massachusetts Boston
      Boston, Massachusetts, United States
    • Alpert Medical School - Brown University
      • Department of Obstetrics and Gynecology
      Providence, RI, United States
  • 2003–2011
    • Hospital of the University of Pennsylvania
      • Department of Genetics
      Philadelphia, Pennsylvania, United States
  • 2010
    • Policlinico S.Orsola-Malpighi
      Bolonia, Emilia-Romagna, Italy
  • 2008–2009
    • Cedars-Sinai Medical Center
      • Cedars Sinai Medical Center
      Los Angeles, California, United States
  • 2005–2009
    • Northwestern University
      • • Division of Endocrinology, Metabolism and Molecular Medicine
      • • Feinberg School of Medicine
      Evanston, IL, United States
    • Duke University Medical Center
      • Department of Obstetrics and Gynecology
      Durham, NC, United States
    • The University of Chicago Medical Center
      • Department of Medicine
      Chicago, IL, United States
  • 2006
    • University of Chicago
      • Department of Medicine
      Chicago, IL, United States
  • 2000–2006
    • University of California, Los Angeles
      • Department of Obstetrics and Gynecology
      Los Angeles, California, United States
  • 2002
    • Boston Children's Hospital
      • Division of Endocrinology
      Boston, MA, United States
    • Brigham and Women's Hospital
      • Division of Women’s Health
      Boston, MA, United States
  • 2000–2002
    • West Georgia Obstetrics and Gynecology
      Georgetown, Georgia, United States
  • 2000–2001
    • University of Pennsylvania
      • Department of Genetics
      Filadelfia, Pennsylvania, United States
  • 1992–1996
    • University of Southern California
      • Department of Obstetrics and Gynecology
      Los Angeles, CA, United States