2022
Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial
Taylor H, Li HJ, Carson S, Flores V, Pal L, Robbins J, Santoro NF, Segars JH, Seifer D, Huang H, Young S, Zhang H. Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial. BMJ Open 2022, 12: e052043. PMID: 35715184, PMCID: PMC9207753, DOI: 10.1136/bmjopen-2021-052043.Peer-Reviewed Original ResearchConceptsEndometriosis-associated infertilityPlacebo-controlled trialGnRH antagonistFertility treatmentOral GnRH antagonistEndometriosis-related infertilityFertilization-embryo transferLive birth rateUse of gonadotropinsEtiology of infertilityInstitutional review boardAntagonist pretreatmentCommon complicationObstetrical outcomesPeer-reviewed journalsSecondary outcomesIVF treatmentPrimary outcomeHormone agonistImplantation ratePregnancy rateLive birthsEndometriosisLocal protocolsOocyte numberEffects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial
Legro RS, Hansen KR, Diamond MP, Steiner AZ, Coutifaris C, Cedars MI, Hoeger KM, Usadi R, Johnstone EB, Haisenleder DJ, Wild RA, Barnhart KT, Mersereau J, Trussell JC, Krawetz SA, Kris-Etherton PM, Sarwer DB, Santoro N, Eisenberg E, Huang H, Zhang H, . Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial. PLOS Medicine 2022, 19: e1003883. PMID: 35041662, PMCID: PMC8765626, DOI: 10.1371/journal.pmed.1003883.Peer-Reviewed Original ResearchConceptsHealthy live birthIntensive lifestyle interventionLifestyle interventionLive birthsWeight lossExercise interventionPrimary outcomeBirth outcomesMetabolic healthInfertility treatmentPhysical activityOvarian stimulation/intrauterine inseminationIntensive groupFirst trimester pregnancy lossIntensive lifestyle groupLifestyle modification groupPreconception lifestyle interventionStandard exercise interventionAcute weight lossTrimester pregnancy lossGastrointestinal side effectsSignificant weight lossLive birth incidenceLifestyle groupUnexplained infertility
2021
Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location
Barnhart KT, Hansen KR, Stephenson MD, Usadi R, Steiner AZ, Cedars MI, Jungheim ES, Hoeger KM, Krawetz SA, Mills B, Alston M, Coutifaris C, Senapati S, Sonalkar S, Diamond MP, Wild RA, Rosen M, Sammel MD, Santoro N, Eisenberg E, Huang H, Zhang H, Legro R, Guzick D, Branum A, Goldman M, Redmon B, Thomas M, Witter F, Brannigan R, Cato P, Coney P, Inoue L, Missmer S. Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location. JAMA 2021, 326: 390-400. PMID: 34342619, PMCID: PMC8335579, DOI: 10.1001/jama.2021.10767.Peer-Reviewed Original ResearchConceptsExpectant managementInitial management strategyUterine evacuationPregnancy resolutionCommon adverse eventsExpectant management strategyEctopic pregnancyEligible patientsSuccessful resolutionAdverse eventsPrimary outcomeInherent morbidityNonviable pregnanciesStable womenNoninferiority marginClinical trialsMedical CenterMAIN OUTCOMEHigh riskPregnancyPatientsMethotrexateActive managementSubstantial crossoverPrimary hypothesis
2020
The effect of antioxidants on male factor infertility: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial
Steiner AZ, Hansen KR, Barnhart KT, Cedars MI, Legro RS, Diamond MP, Krawetz SA, Usadi R, Baker VL, Coward RM, Huang H, Wild R, Masson P, Smith JF, Santoro N, Eisenberg E, Zhang H, Network R. The effect of antioxidants on male factor infertility: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial. Fertility And Sterility 2020, 113: 552-560.e3. PMID: 32111479, PMCID: PMC7219515, DOI: 10.1016/j.fertnstert.2019.11.008.Peer-Reviewed Original ResearchConceptsMonths of treatmentMale factor infertilityFactor infertilityLive birthsSemen parametersPlacebo groupPrimary outcomeSperm concentrationPlacebo-controlled trialLive birth rateCumulative live birthDNA fragmentationFemale partnersSperm DNA fragmentation indexLycopene dailyVivo pregnancyClomiphene citrateSecondary outcomesEntire cohortAsthenospermic menFertility centerIntrauterine inseminationMonth 4Tubal patencyClinical trials
2015
Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility
Diamond MP, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson P, Christman GM, Ager J, Huang H, Hansen KR, Baker V, Usadi R, Seungdamrong A, Bates GW, Rosen RM, Haisenleder D, Krawetz SA, Barnhart K, Trussell JC, Ohl D, Jin Y, Santoro N, Eisenberg E, Zhang H. Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility. New England Journal Of Medicine 2015, 373: 1230-1240. PMID: 26398071, PMCID: PMC4739644, DOI: 10.1056/nejmoa1414827.Peer-Reviewed Original ResearchConceptsUnexplained infertilityMultiple gestationsOvarian stimulationClinical pregnancyStandard therapyLive birth ratePatent fallopian tubesMultiple gestation ratesYears of ageFetal heart activityLetrozole groupNeonatal complicationsClomiphene citrateTriplet gestationsOngoing pregnancyPrimary outcomeGonadotropin treatmentFallopian tubeGestation rateCongenital anomaliesPregnancy rateWomen 18Live birthsClomipheneLetrozole
2014
Letrozole versus Clomiphene for Infertility in the Polycystic Ovary Syndrome
Legro RS, Brzyski RG, Diamond MP, Coutifaris C, Schlaff WD, Casson P, Christman GM, Huang H, Yan Q, Alvero R, Haisenleder DJ, Barnhart KT, Bates GW, Usadi R, Lucidi S, Baker V, Trussell JC, Krawetz SA, Snyder P, Ohl D, Santoro N, Eisenberg E, Zhang H. Letrozole versus Clomiphene for Infertility in the Polycystic Ovary Syndrome. New England Journal Of Medicine 2014, 371: 119-129. PMID: 25006718, PMCID: PMC4175743, DOI: 10.1056/nejmoa1313517.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeOvary syndromeCongenital anomaliesLive birthsHigh incidenceOvulation rateSignificant between-group differencesCumulative ovulation rateNormal uterine cavityOverall congenital anomaliesBetter pregnancy outcomesPatent fallopian tubesCumulative live birthMajor congenital anomaliesBetween-group differencesYears of ageClomiphene groupLetrozole groupRotterdam criteriaAdverse eventsHot flushesPregnancy outcomesInfertile womenMulticenter trialPrimary outcome