Bio

Clinical Focus


  • Obstetrics and Gynecology

Academic Appointments


Professional Education


  • Medical Education:Uniformed Services University Office of the Registrar (1986) MD
  • Board Certification: Reprod. Endocrinology and Infertility, American Board of Obstetrics and Gynecology (1998)
  • Fellowship:National Institute Of Health (NINDS) (1995) MD
  • Residency:Walter Reed Army Medical Center (1990) MD

Publications

All Publications


  • Cultural Experiences, Patterns, and Practices of American Indian Women With Polycystic Ovary Syndrome: An Ethnonursing Study. Journal of transcultural nursing : official journal of the Transcultural Nursing Society Carron, R., Kooienga, S., Gilman-Kehrer, E., Alvero, R. 2019: 1043659619856670

    Abstract

    Introduction: Knowledge is needed about the cultural experiences, patterns, and practices of American Indian women with polycystic ovary syndrome (PCOS), so nurses can provide culturally congruent care. Method: A qualitative, ethnonursing study based on Leininger's theory of culture care diversity and universality. Data were collected from 13 key informants living on a reservation in the Western United States. Data were analyzed with Leininger's four phases of qualitative analysis. Results: Three universal themes were identified: (1) control of PCOS symptoms is important for the cultural well-being of tribal women, (2) culturally congruent PCOS education and health care are important with variations in approaches to treatment, and (3) tribal culture is important with variations in use of tribal practices. Discussion: Tribal culture affects the health care beliefs and practices of American Indian women with PCOS. The findings can be used to improve culturally congruent care for women with this chronic condition.

    View details for DOI 10.1177/1043659619856670

    View details for PubMedID 31204601

  • Gestational Weight Gain in Women With Polycystic Ovary Syndrome: A Controlled Study. The Journal of clinical endocrinology and metabolism Kent, J., Dodson, W. C., Kunselman, A., Pauli, J., Stone, A., Diamond, M. P., Coutifaris, C., Schlaff, W. D., Alvero, R., Casson, P., Christman, G. M., Rosen, R. M., Hansen, K. R., Robinson, R. D., Baker, V., Usadi, R., Santoro, N., Zhang, H., Eisenberg, E., Legro, R. S., Reproductive Medicine Network 2018; 103 (11): 4315–23

    Abstract

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

    View details for PubMedID 30085187

  • Allostatic load, a measure of chronic physiological stress, is associated with pregnancy outcomes, but not fertility, among women with unexplained infertility. Human reproduction (Oxford, England) Barrett, E. S., Vitek, W., Mbowe, O., Thurston, S. W., Legro, R. S., Alvero, R., Baker, V., Bates, G. W., Casson, P., Coutifaris, C., Eisenberg, E., Hansen, K., Krawetz, S., Robinson, R., Rosen, M., Usadi, R., Zhang, H., Santoro, N., Diamond, M. 2018; 33 (9): 1757–66

    Abstract

    STUDY QUESTION: Among infertile women undergoing ovarian stimulation, is allostatic load (AL), a measure of chronic physiological stress, associated with subsequent fertility and pregnancy outcomes?SUMMARY ANSWER: AL at baseline was not associated with conception, spontaneous abortion or live birth, however, it was significantly associated with increased odds of pre-eclampsia and preterm birth among women who had a live birth in the study.WHAT IS KNOWN ALREADY: Several studies have linked AL during pregnancy to adverse outcomes including preterm birth and pre-eclampsia, hypothesizing that it may contribute to well-documented disparities in pregnancy and birth outcomes. However, AL biomarkers change over the course of pregnancy, raising questions as to whether gestational AL assessment is a valid measure of cumulative physiologic stress starting long before pregnancy. To better understand how AL may impact reproductive outcomes, AL measurement in the non-pregnant state (i.e. prior to conception) is needed.STUDY DESIGN, SIZE, DURATION: A secondary data analysis based on data from 836 women who participated in Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), a multi-center, randomized clinical trial of ovarian stimulation conducted from 2011 to 2014.PARTICIPANTS/MATERIALS, SETTING, METHODS: Ovulatory women with unexplained infertility (ages 18-40) were enrolled and at baseline, biological and anthropometric measures were collected. AL scores were calculated as a composite of the following baseline variables determined a priori: BMI, waist-to-hip ratio, systolic blood pressure, diastolic blood pressure, dehydroepiandrosterone sulfate, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, C-reactive protein and HOMA score. Participants received ovarian stimulation for up to four cycles and if they conceived, were followed throughout pregnancy. We fit multi-variable logistic regression models examining AL (one-tailed and two-tailed) in relation to the following reproductive outcomes: conception, spontaneous abortion, live birth, pre-eclampsia, preterm birth and low birthweight.MAIN RESULTS AND THE ROLE OF CHANCE: Adjusting for covariates, a unit increase in two-tailed AL score was associated with 62% increased odds of pre-eclampsia (OR: 1.62, 95% CI: 1.14, 2.38) 44% increased odds of preterm birth (OR: 1.44, 95% CI: 1.02, 2.08), and 39% increased odds of low birthweight (OR: 1.39, 95% CI: 0.99, 1.97). The relationship between AL and preterm birth was mediated by pre-eclampsia (P = 0.0003). In one-tailed AL analyses, associations were similar, but slightly attenuated. AL was not associated with fertility outcomes (conception, spontaneous abortion, live birth).LIMITATIONS, REASONS FOR CAUTION: Results may not be generalizable to fertile women who conceive naturally or women with other types of infertility. Comparisons to previous, related work are difficult because variables included in AL composite measures vary across studies. AL may be indicative of overall poor health, rather than being specific to chronic physiological stress.WIDER IMPLICATIONS OF THE FINDINGS: Our results suggest that chronic physiological stress may not impact success of ovarian stimulation, however, they confirm and extend previous work suggesting that AL is associated with adverse pregnancy outcomes. Physiological dysregulation due to chronic stress has been proposed as a possible mechanism underlying disparities in birth outcomes, which are currently poorly understood. Assessing biomarkers of physiological dysregulation pre-conception or in early pregnancy, may help to identify women at risk of adverse pregnancy outcomes, particularly pre-eclampsia.STUDY FUNDING/COMPETING INTEREST(S): Support for AMIGOS was provided by: U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936 and U10HD055925. Support for the current analysis was provided by T32ES007271, R25HD075737, P30ES001247 and P30ES005022. This research was made possible by funding by American Recovery and Reinvestment Act. The content is solely the responsibility of the authors and does not necessarily represent the official views of NICHD, NIEHS or NIH. E.B., W.V., O.M., R.A., M.R., V.B., G.W.B., C.C., E.E., S.K., R.U., P.C, H.Z., N.S. and S.T. have nothing to disclose. R.L. reported serving as a consultant to Abbvie, Bayer, Kindex, Odega, Millendo and Fractyl and serving as a site investigator and receiving grants from Ferring. K.H. reported receiving grants from Roche Diagnostics and Ferring. R.R. reported a grant from AbbVie. M.D. reported being on the Board of Directors of and a stockholder in Advanced Reproductive Care.TRIAL REGISTRATION NUMBER: Clinical Trials.gov number: NCT01044862.

    View details for PubMedID 30085177

  • Midluteal Progesterone: A Marker of Treatment Outcomes in Couples With Unexplained Infertility JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM Hansen, K. R., Eisenberg, E., Baker, V., Hill, M. J., Chen, S., Talken, S., Diamond, M. P., Legro, R. S., Coutifaris, C., Alvero, R., Robinson, R. D., Casson, P., Christman, G. M., Santoro, N., Zhang, H., Wild, R. A., NICHD Reproductive Med Network 2018; 103 (7): 2743–51

    Abstract

    Adequate luteal phase progesterone exposure is necessary to induce endometrial changes required for a successful pregnancy outcome. The relationship between low midluteal progesterone concentration and the outcome of live birth in ovarian stimulation with intrauterine insemination (OS-IUI) treatments is not defined.To determine the level of midluteal progesterone portending a low chance of live birth after OS-IUI in couples with unexplained infertility.Secondary analyses of data from a prospective, randomized, multicenter clinical trial that determined pregnancy outcomes following OS-IUI with clomiphene citrate, letrozole, or gonadotropins for couples with unexplained infertility.Couples (n = 900) underwent 2376 OS-IUI cycles during the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation clinical trial.Live birth as it relates to midluteal progesterone level and thresholds below which no live births occur by treatment group.Thresholds for non-live birth cycles were similar for clomiphene (14.4 ng/mL) and letrozole (13.1 ng/mL) yet were lower for gonadotropin (4.3 ng/mL) treatments. A midluteal progesterone level >10th percentile specific for each treatment group independently was associated with greater odds for a live birth in all OS-IUI cycles (adjusted OR: 2.17; 95% CI: 1.05, 4.48).During OS-IUI, a low midluteal progesterone level was associated with a low probability of live birth. Thresholds differed by medication, with the lowest threshold for gonadotropin. Several pathophysiologic mechanisms may account for low progesterone levels. Refinement of the predictive range associated with particular ovarian stimulation medications during treatment of unexplained infertility may improve accuracy.

    View details for PubMedID 29767754

  • Sexual function in infertile women with polycystic ovary syndrome and unexplained infertility. American journal of obstetrics and gynecology Diamond, M. P., Legro, R. S., Coutifaris, C., Alvero, R., Robinson, R. D., Casson, P. A., Christman, G. M., Huang, H., Hansen, K. R., Baker, V., Usadi, R., Seungdamrong, A., Bates, G. W., Rosen, R. M., Schlaff, W., Haisenleder, D., Krawetz, S. A., Barnhart, K., Trussell, J. C., Santoro, N., Eisenberg, E., Zhang, H. 2017

    Abstract

    While female sexual dysfunction is a frequent occurrence, characteristics in infertile women are not well delineated. Furthermore, the impact of infertility etiology on the characteristics in women with differing androgen levels observed in women with polycystic ovary syndrome and unexplained infertility has not been assessed.The objective of the study was to determine the characteristics of sexual dysfunction in women with polycystic ovary syndrome and unexplained infertility.A secondary data analysis was performed on 2 of Eunice Kennedy Shriver National Institute of Child Health and Human Development Cooperative Reproductive Medicine Networks clinical trials: Pregnancy in Polycystic Ovary Syndrome Study II and Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. Both protocols assessed female sexual function using the Female Sexual Function Inventory and the Female Sexual Distress Scale.Women with polycystic ovary syndrome had higher weight and body mass index than women with unexplained infertility (each P < .001), greater phenotypic (Ferriman-Gallwey hirsutism score, sebum score, and acne score; each P < .001), and hormonal (testosterone, free testosterone, and dehydroepiandrosterone; each P < .001) evidence of androgen excess. Sexual function scores, as assessed by the Female Sexual Function Inventory, were nearly identical. The Female Sexual Distress Scale total score was higher in women with polycystic ovary syndrome. The mean Female Sexual Function Inventory total score increased slightly as the free androgen index increased, mainly as a result of the desire subscore. This association was more pronounced in the women with unexplained infertility.Reproductive-age women with infertility associated with polycystic ovary syndrome and unexplained infertility, despite phenotypic and biochemical differences in androgenic manifestations, do not manifest clinically significant differences in sexual function.

    View details for DOI 10.1016/j.ajog.2017.04.034

    View details for PubMedID 28455078

  • Recruitment strategies in two reproductive medicine network infertility trials CONTEMPORARY CLINICAL TRIALS Usadi, R. S., Diamond, M. P., Legro, R. S., Schlaff, W. D., Hansen, K. R., Casson, P., Christman, G., Bates, G. W., Baker, V., Seungdamrong, A., Rosen, M. P., Lucidi, S., Thomas, T., Huang, H., Santoro, N., Eisenberg, E., Zhang, H., Alvero, R. 2015; 45: 196-200

    Abstract

    Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited.We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials.3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials.Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment.

    View details for DOI 10.1016/j.cct.2015.09.010

    View details for Web of Science ID 000367755200009

    View details for PubMedCentralID PMC4766588

  • Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility NEW ENGLAND JOURNAL OF MEDICINE Diamond, M. P., Legro, R. S., Coutifaris, C., Alvero, R., Robinson, R. D., Casson, P., Christman, G. M., Ager, J., Huang, H., Hansen, K. R., Baker, V., Usadi, R., Seungdamrong, A., Bates, G. W., Rosen, R. M., HAISENLEDER, D., Krawetz, S. A., Barnhart, K., Trussell, J. C., Ohl, D., Jin, Y., Santoro, N., Eisenberg, E., Zhang, H. 2015; 373 (13): 1230-1240

    Abstract

    The standard therapy for women with unexplained infertility is gonadotropin or clomiphene citrate. Ovarian stimulation with letrozole has been proposed to reduce multiple gestations while maintaining live birth rates.We enrolled couples with unexplained infertility in a multicenter, randomized trial. Ovulatory women 18 to 40 years of age with at least one patent fallopian tube were randomly assigned to ovarian stimulation (up to four cycles) with gonadotropin (301 women), clomiphene (300), or letrozole (299). The primary outcome was the rate of multiple gestations among women with clinical pregnancies.After treatment with gonadotropin, clomiphene, or letrozole, clinical pregnancies occurred in 35.5%, 28.3%, and 22.4% of cycles, and live birth in 32.2%, 23.3%, and 18.7%, respectively; pregnancy rates with letrozole were significantly lower than the rates with standard therapy (gonadotropin or clomiphene) (P=0.003) or gonadotropin alone (P<0.001) but not with clomiphene alone (P=0.10). Among ongoing pregnancies with fetal heart activity, the multiple gestation rate with letrozole (9 of 67 pregnancies, 13%) did not differ significantly from the rate with gonadotropin or clomiphene (42 of 192, 22%; P=0.15) or clomiphene alone (8 of 85, 9%; P=0.44) but was lower than the rate with gonadotropin alone (34 of 107, 32%; P=0.006). All multiple gestations in the clomiphene and letrozole groups were twins, whereas gonadotropin treatment resulted in 24 twin and 10 triplet gestations. There were no significant differences among groups in the frequencies of congenital anomalies or major fetal and neonatal complications.In women with unexplained infertility, ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth, as compared with gonadotropin but not as compared with clomiphene. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01044862.).

    View details for DOI 10.1056/NEJMoa1414827

    View details for PubMedID 26398071

  • Identification and replication of prediction models for ovulation, pregnancy and live birth in infertile women with polycystic ovary syndrome. Human reproduction Kuang, H., Jin, S., Hansen, K. R., Diamond, M. P., Coutifaris, C., Casson, P., Christman, G., Alvero, R., Huang, H., Bates, G. W., Usadi, R., Lucidi, S., Baker, V., Santoro, N., Eisenberg, E., Legro, R. S., Zhang, H. 2015; 30 (9): 2222-2233

    Abstract

    Can we build and validate predictive models for ovulation and pregnancy outcomes in infertile women with polycystic ovary syndrome (PCOS)?We were able to develop and validate a predictive model for pregnancy outcomes in women with PCOS using simple clinical and biochemical criteria particularly duration of attempting conception, which was the most consistent predictor among all considered factors for pregnancy outcomes.Predictive models for ovulation and pregnancy outcomes in infertile women with polycystic ovary syndrome have been reported, but such models require validation.This is a secondary analysis of the data from the Pregnancy in Polycystic Ovary Syndrome I and II (PPCOS-I and -II) trials. Both trials were double-blind, randomized clinical trials that included 626 and 750 infertile women with PCOS, respectively. PPCOS-I participants were randomized to either clomiphene citrate (CC), metformin, or their combination, and PPCOS-II participants to either letrozole or CC for up to five treatment cycles.Linear logistic regression models were fitted using treatment, BMI, and other published variables as predictors of ovulation, conception, clinical pregnancy, and live birth as the outcome one at a time. We first evaluated previously reported significant predictors, and then constructed new prediction models. Receiver operating characteristic (ROC) curves were constructed and the area under the curves (AUCs) was calculated to compare performance using different models and data. Chi-square tests were used to examine the goodness-of-fit and prediction power of logistic regression model.Predictive factors were similar between PPCOS-I and II, but the two participant samples differed statistically significantly but the differences were clinically minor on key baseline characteristics and hormone levels. Women in PPCOS-II had an overall more severe PCOS phenotype than women in PPCOS-I. The clinically minor but statistically significant differences may be due to the large sample sizes. Younger age, lower baseline free androgen index and insulin, shorter duration of attempting conception, and higher baseline sex hormone-binding globulin significantly predicted at least one pregnancy outcome. The ROC curves (with AUCs of 0.66-0.76) and calibration plots and chi-square tests indicated stable predictive power of the identified variables (P-values ≥0.07 for all goodness-of-fit and validation tests).This is a secondary analysis. Although our primary objective was to confirm previously reported results and identify new predictors of ovulation and pregnancy outcomes among PPCOS-II participants, our approach is exploratory and warrants further replication.We have largely confirmed the predictors that were identified in the PPCOS-I trial. However, we have also revealed new predictors, particularly the role of smoking. While a history of ever smoking was not a significant predictor for live birth, a closer look at current, quit, and never smoking revealed that current smoking was a significant risk factor.The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Grants U10 HD27049, U10 HD38992, U10HD055925, U10 HD39005, U10 HD33172, U10 HD38998, U10 HD055936, U10 HD055942, and U10 HD055944; and U54-HD29834. Heilongjiang University of Chinese Medicine Grants 051277 and B201005. R.S.L. reports receiving consulting fees from Euroscreen, AstraZeneca, Clarus Therapeutics, and Takeda, and grant support from Ferring, Astra Zeneca, and Toba. K.R.H. reports receiving grant support from Roche Diagnostics and Ferring Pharmascience. G.C. reports receiving Honorarium and grant support from Abbvie Pharmaceuticals and Bayer Pharmaceuticals. M.P.D. holds equity from Advanced Reproductive Care Inc. and DS Biotech, receives fees from Advanced Reproductive Care Inc., Actamax, Auxogyn, ZSX Medical, Halt Medical, and Neomed, and receives grant support from Boehringer-Ingelheim, Abbott, and BioSante, Ferring Pharmaceuticals, and EMD Serono. H.Z. receives research support from the Chinese 1000-scholar plan. Others report no disclosures other than NIH grant support.PPCOS-I and -II were respectively registered at Clinicaltrials.gov: NCT00719186 and NCT00719186.

    View details for DOI 10.1093/humrep/dev182

    View details for PubMedID 26202922

    View details for PubMedCentralID PMC4542721

  • Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics FERTILITY AND STERILITY Diamond, M. P., Legro, R. S., Coutifaris, C., Alvero, R., Robinson, R. D., Casson, P., Christman, G. M., Ager, J., Huang, H., Hansen, K. R., Baker, V., Usadi, R., Seungdamrong, A., Bates, G. W., Rosen, R. M., Haisonleder, D., Krawetz, S. A., Barnhart, K., Trussell, J. C., Jin, Y., Santoro, N., Eisenberg, E., Zhang, H. 2015; 103 (4): 962-U143

    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.

    View details for DOI 10.1016/j.fertnstert.2014.12.130

    View details for Web of Science ID 000352110400024

    View details for PubMedID 25707331

  • Recruitment strategies in two reproductive medicine network infertility trials. Contemporary clinical trials Usadi, R. S., Diamond, M. P., Legro, R. S., Schlaff, W. D., Hansen, K. R., Casson, P., Christman, G., Wright Bates, G., Baker, V., Seungdamrong, A., Rosen, M. P., Lucidi, S., Thomas, T., Huang, H., Santoro, N., Eisenberg, E., Zhang, H., Alvero, R. 2015; 45 (Pt B): 196–200

    Abstract

    Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited.We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials.3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials.Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment.

    View details for PubMedID 26386293

  • Multivariate analysis of factors affecting probability of pregnancy and live birth with in vitro fertilization: an analysis of the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System FERTILITY AND STERILITY Baker, V. L., Luke, B., Brown, M. B., Alvero, R., Frattarelli, J. L., Usadi, R., Grainger, D. A., Armstrong, A. Y. 2010; 94 (4): 1410-1416

    Abstract

    To evaluate factors predictive of clinical pregnancy and of pregnancy loss from assisted reproductive technology (ART) using data from the Society for Assisted Reproductive Technology database for 2004-2006.Retrospective cohort.Clinic-based data.The study population included 225,889 fresh embryo transfer cycles using autologous oocytes and partner semen.None.Clinical intrauterine gestation (presence of gestational sac) and live birth (>or=22 weeks gestation and >or=300 g birth weight).Increasing maternal age was significantly associated with a reduced odds of conception and increased fetal loss until 19 weeks gestation, but not with later pregnancy loss. Intracytoplasmic sperm injection (ICSI), assisted hatching, and increasing number of embryos transferred had significant positive effects on the odds of conception and pregnancy continuation through the first trimester, but did not affect the risk of later loss. Blacks, Asians, and Hispanics had significantly lower odds of clinical pregnancy compared with whites. Also compared with whites, Hispanics and Asians had a significantly greater risk of pregnancy loss in the second and third trimesters, and blacks had a significantly greater risk of pregnancy loss in all trimesters.Certain demographic and ART treatment parameters influenced chance of conception and early pregnancy loss, whereas black race and Hispanic ethnicity were also significantly associated with late pregnancy loss in ART-conceived pregnancies.

    View details for DOI 10.1016/j.fertnstert.2009.07.986

    View details for Web of Science ID 000281674600041

    View details for PubMedID 19740463