2024
How to minimize the dropout and crossover in an infertility trial?
Huang H, Kuang H, Thomas T, Wei D, Zhang H. How to minimize the dropout and crossover in an infertility trial? Fertility And Sterility 2024, 121: 905-908. PMID: 38316206, DOI: 10.1016/j.fertnstert.2024.01.035.Peer-Reviewed Original ResearchMeSH KeywordsCross-Over StudiesFemaleHumansInfertilityIntention to Treat AnalysisMalePatient DropoutsRandomized Controlled Trials as TopicReproductive Techniques, AssistedTreatment OutcomeFibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) – protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids
Al-Hendy A, Segars J, Taylor H, González F, Siblini H, Zamah M, Alkelani H, Singh B, Flores V, Christman G, Johnson J, Huang H, Zhang H. Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) – protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids. BMJ Open 2024, 14: e078989. PMID: 38216200, PMCID: PMC10806662, DOI: 10.1136/bmjopen-2023-078989.Peer-Reviewed Original ResearchMeSH KeywordsCatechinChildFemaleFertilityGonadotropin-Releasing HormoneHumansInfertilityLeiomyomaMulticenter Studies as TopicOvulation InductionPregnancyPregnancy RateProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTeaConceptsUnexplained infertilityIntrauterine inseminationInstitutional review boardCumulative live birth rateUterine fibroidsLive birth rateCause of infertilityFood and Drug AdminstrationGonadotropin hormone-releasing hormoneGreen tea extractDouble-blind clinical trialNon-surgical treatment optionsTimed intrauterine inseminationUterine fibroid sizeOvarian stimulationQuality of Life Questionnaire scoresHormone-releasing hormoneLocal institutional review boardInfertility treatmentNational Institute of Child HealthInstitute of Child HealthMiscarriage rateBirth rateReproductive-age womenEndometrial quality
2020
Factors associated with study protocol adherence and bio banking participation in reproductive medicine clinical trials and their relationship to live birth
Engmann L, Sun F, Legro RS, Diamond MP, Zhang H, Santoro N, Bartlebaugh C, Dodson W, Estes S, Ober J, Brzyski R, Easton C, Hernandez A, Leija M, Pierce D, Robinson R, Awonuga A, Cedo L, Cline A, Collins K, Krawetz S, Puscheck E, Singh M, Yoscovits M, Barnhart K, Coutifaris C, Lecks K, Martino L, Marunich R, Snyder P, Alvero R, Comfort A, Crow M, Schlaff W, Casson P, Hohmann A, Mallette S, Christman G, Ohl D, Ringbloom M, Tang J, Bates G, Mason S, DiMaria N, Usadi R, Lucidi R, Rhea M, Baker V, Turner K, Trussell J, DelBasso D, Huang H, Li Y, Makuch R, Patrizio P, Sakai L, Scahill L, Taylor H, Thomas T, Tsang S, Yan Q, Zhang M, Haisenleder D, Lamar C, DePaolo L, Herring A, Redmond J, Thomas M, Turek P, Wactawski-Wende J, Rebar R, Cato P, Dukic V, Lewis V, Schlegel P, Witter F. Factors associated with study protocol adherence and bio banking participation in reproductive medicine clinical trials and their relationship to live birth. Human Reproduction 2020, 35: 2819-2831. PMID: 33190149, PMCID: PMC8453415, DOI: 10.1093/humrep/deaa232.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultFemaleHumansInfertility, FemaleLive BirthMaleMulticenter Studies as TopicOvulation InductionPregnancyPregnancy RateProspective StudiesRandomized Controlled Trials as TopicReproductive MedicineYoung AdultConceptsPolycystic ovary syndromeClinical trial protocolMedicine clinical trialsU10 HD055942U10 HD38998Baseline characteristicsTrial protocolClinical trialsLive birthsPolycystic Ovary Syndrome IIU10 HD38992U10 HD39005U10 HD27049STUDY FUNDING/COMPETINGMultiple Intrauterine GestationsStudy protocol adherenceUS multicenter trialRegular ovulatory cyclesClinical trial findingsPolycystic ovarian morphologyPARTICIPANTS/MATERIALSROLE OF CHANCELower household incomeAfrican AmericansAspects of adherencePregnancy registry: three-year follow-up of children conceived from letrozole, clomiphene, or gonadotropins
Legro RS, Diamond MP, Coutifaris C, Schlaff WD, Alvero R, Casson P, Christman GM, Rosen RM, Cedars MI, Hansen KR, Robinson R, Baker V, Usadi R, Dodson WC, Estes SJ, Kunselman A, Stetter C, Barnhart KT, Coward RM, Trussell JC, Krawetz SA, Santoro N, Huang H, Zhang H, Eisenberg E, Network R. Pregnancy registry: three-year follow-up of children conceived from letrozole, clomiphene, or gonadotropins. Fertility And Sterility 2020, 113: 1005-1013. PMID: 32386612, PMCID: PMC7376442, DOI: 10.1016/j.fertnstert.2019.12.023.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsChild BehaviorChild DevelopmentChild, PreschoolClomipheneCognitionFemaleFertilityFertility AgentsFollow-Up StudiesGesturesGonadotropinsHumansInfantInfertility, FemaleLetrozoleLive BirthMaleOvulation InductionPolycystic Ovary SyndromePregnancyProspective StudiesRandomized Controlled Trials as TopicRegistriesTreatment OutcomeUnited StatesWeight GainConceptsGN groupMultiple pregnancy rateProspective cohort studyPolycystic ovary syndromeChildren of womenInfertility trialsUnexplained infertilityCohort studyII studyMultiple gestationsOvary syndromeHealth centersInfertility treatmentPregnancy rateInfertility therapyMAIN OUTCOMELTZ groupLetrozoleMacArthur-Bates Communicative Development InventoriesAcademic health centersGonadotropinAbnormal scoresClomipheneCC groupDevelopmental Questionnaire
2019
Association between testosterone, semen parameters, and live birth in men with unexplained infertility in an intrauterine insemination population
Trussell JC, Coward RM, Santoro N, Stetter C, Kunselman A, Diamond MP, Hansen KR, Krawetz SA, Legro RS, Heisenleder D, Smith J, Steiner A, Wild R, Casson P, Coutifaris C, Alvero RR, Robinson RB, Christman G, Patrizio P, Zhang H, Lindgren MC, Network R. Association between testosterone, semen parameters, and live birth in men with unexplained infertility in an intrauterine insemination population. Fertility And Sterility 2019, 111: 1129-1134. PMID: 30982604, PMCID: PMC6557574, DOI: 10.1016/j.fertnstert.2019.01.034.Peer-Reviewed Original ResearchMeSH KeywordsAdultBiomarkersDown-RegulationFemaleFertilityHumansInfertility, MaleInsemination, Artificial, HomologousLive BirthMaleMulticenter Studies as TopicPregnancyPregnancy RateRandomized Controlled Trials as TopicRisk FactorsSperm CountSperm MotilitySpermatogenesisTestosteroneTreatment OutcomeConceptsUnexplained infertilityLow TTMale partnersLive birthsSemen parametersSecondary analysisMultiple Intrauterine GestationsLive birth rateBody mass indexMulticenter clinical trialAbnormal sperm morphologyOvarian stimulationIntrauterine gestationPregnancy outcomesMass indexInfertility clinicClinical trialsMAIN OUTCOMETotal motile spermSemen analysisAbnormal spermatogenesisInfertilityLogistic regressionSperm concentrationSemen volume
2018
The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials
Diamond MP, Eisenberg E, Huang H, Coutifaris C, Legro RS, Hansen KR, Steiner AZ, Cedars M, Barnhart K, Ziolek T, Thomas TR, Maurer K, Krawetz SA, Wild RA, Trussell J, Santoro N, Zhang H, Network F. The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials. Clinical Trials 2018, 16: 3-10. PMID: 30354458, PMCID: PMC6384136, DOI: 10.1177/1740774518807888.Peer-Reviewed Original ResearchMeSH KeywordsClinical ProtocolsEthics Committees, ResearchHumansMulticenter Studies as TopicNational Institute of Child Health and Human Development (U.S.)Randomized Controlled Trials as TopicReproductive MedicineTime FactorsUnited StatesConceptsInstitutional review boardReproductive Medicine NetworkPast clinical trialsClinical trialsReview boardChild healthNational InstituteClinical researchMedicine NetworkSingle institutional review boardInstitutional review board approvalCurrent clinical trialsInstitutional review board submissionLocal institutional review boardReview board approvalVitamin D Deficiency Is Associated With Poor Ovarian Stimulation Outcome in PCOS but Not Unexplained Infertility
Butts SF, Seifer DB, Koelper N, Senapati S, Sammel MD, Hoofnagle AN, Kelly A, Krawetz SA, Santoro N, Zhang H, Diamond MP, Legro RS, Network E. Vitamin D Deficiency Is Associated With Poor Ovarian Stimulation Outcome in PCOS but Not Unexplained Infertility. The Journal Of Clinical Endocrinology & Metabolism 2018, 104: 369-378. PMID: 30085176, PMCID: PMC6300410, DOI: 10.1210/jc.2018-00750.Peer-Reviewed Original ResearchMeSH KeywordsAdultFemaleHumansInfertility, FemaleOvulation InductionPolycystic Ovary SyndromePregnancyPregnancy OutcomeRandomized Controlled Trials as TopicRetrospective StudiesVitamin DVitamin D DeficiencyYoung AdultConceptsVitamin D deficiencyPolycystic ovary syndromeD deficiencyEarly pregnancy lossOvarian stimulationUnexplained infertilityLive birthsPregnancy lossDiagnosis of PCOSMultiple Intrauterine GestationsOvarian stimulation outcomesRetrospective cohort studyInvestigation of womenBanked seraPPCOS IICohort studyIntrauterine gestationOvary syndromeInfertile womenInfertility diagnosisPregnant subjectsElevated riskImportant treatmentReproductive outcomesTrial data
2015
Predictors of participant retention in infertility treatment trials
Kuang H, Jin S, Thomas T, Engmann L, Hansen KR, Coutifaris C, Casson P, Christman G, Alvero R, Santoro N, Eisenberg E, Diamond MP, Legro RS, Zhang H, Network R, Bartlebaugh C, Dodson W, Estes S, Gnatuk C, Ladda R, Ober J, Easton C, Hernandez A, Leija M, Pierce D, Bryzski R, Awonuga A, Cedo L, Cline A, Collins K, Krawetz S, Puscheck E, Singh M, Yoscovits M, Barnhart K, Lecks K, Martino L, Marunich R, Snyder P, Schlaff W, Comfort A, Crow M, Hohmann A, Mallette S, Ringbloom M, Tang J, Mason S, DiMaria N, Rhea M, Turner K, Haisenleder D, Trussell J, DelBasso D, Li Y, Makuch R, Patrizio P, Sakai L, Scahill L, Taylor H, Thomas T, Tsang S, Zhang M, Lamar C, DePaolo L, Guzick D, Herring A, Redmond J, Thomas M, Turek P, Wactawski-Wende J, Rebar R, Cato P, Dukic V, Lewis V, Schlegel P, Witter F. Predictors of participant retention in infertility treatment trials. Fertility And Sterility 2015, 104: 1236-1243.e2. PMID: 26354094, PMCID: PMC4630082, DOI: 10.1016/j.fertnstert.2015.08.001.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdolescentAdultChi-Square DistributionDrug Therapy, CombinationFemaleFertilityFertility Agents, FemaleHumansInfertility, FemaleLogistic ModelsMaleMultivariate AnalysisOdds RatioPatient DropoutsPatient SelectionPolycystic Ovary SyndromePregnancyRandomized Controlled Trials as TopicRisk FactorsTreatment OutcomeYoung AdultConceptsPolycystic ovary syndromeBody mass indexClomiphene citrateClinical trialsHistory of smokingInsurance coverageCombination of metforminMultivariable logistic modelAcademic medical centerRetention of subjectsConduct of RCTsBetter insurance coverageUnexplained infertilityOvary syndromeNormal weightMass indexOriginal RCTTreatment trialsMedical CenterMAIN OUTCOMEWhite raceIntervention studiesRCTsSecondary analysisParticipant retentionIdentification and replication of prediction models for ovulation, pregnancy and live birth in infertile women with polycystic ovary syndrome
Kuang H, Jin S, Hansen KR, Diamond MP, Coutifaris C, Casson P, Christman G, Alvero R, Huang H, Bates GW, Usadi R, Lucidi S, Baker V, Santoro N, Eisenberg E, Legro RS, Zhang H, Network F, Bartlebaugh C, Dodson W, Estes S, Gnatuk C, Ladda R, Ober J, Easton C, Hernandez A, Leija M, Pierce D, Bryzski R, Awonuga A, Cedo L, Cline A, Collins K, Krawetz S, Puscheck E, Singh M, Yoscovits M, Barnhart K, Lecks K, Martino L, Marunich R, Snyder P, Schlaff W, Comfort A, Crow M, Hohmann A, Mallette S, Ringbloom M, Tang J, Mason S, DiMaria N, Rhea M, Turner K, Haisenleder D, Trussell J, DelBasso D, Li Y, Makuch R, Patrizio P, Sakai L, Scahill L, Taylor H, Thomas T, Tsang S, Zhang M, Lamar C, DePaolo L, Guzick D, Herring A, Redmond J, Thomas M, Turek P, Wactawski-Wende J, Rebar R, Cato P, Dukic V, Lewis V, Schlegel P, Witter F. Identification and replication of prediction models for ovulation, pregnancy and live birth in infertile women with polycystic ovary syndrome. Human Reproduction 2015, 30: 2222-2233. PMID: 26202922, PMCID: PMC4542721, DOI: 10.1093/humrep/dev182.Peer-Reviewed Original ResearchMeSH KeywordsAdultFemaleFertilizationHumansInfertility, FemaleLive BirthModels, TheoreticalOvulationPolycystic Ovary SyndromePrognosisRandomized Controlled Trials as TopicConceptsPolycystic ovary syndromePregnancy outcomesInfertile womenClomiphene citrateOvary syndromeChi-square testLogistic regression modelsLive birthsBaseline sex hormone-binding globulinPolycystic Ovary Syndrome ISecondary analysisEunice Kennedy Shriver National InstituteSex hormone-binding globulinSevere PCOS phenotypeFree androgen indexRole of smokingKey baseline characteristicsHormone-binding globulinSignificant risk factorsPARTICIPANTS/MATERIALSSignificant predictorsROLE OF CHANCEPredictors of ovulationGrant supportNIH grant support
2011
Recruitment challenges of a multicenter randomized controlled varicocelectomy trial
Trussell JC, Christman GM, Ohl DA, Legro RS, Krawetz SA, Snyder PJ, Patrizio P, Polotsky AJ, Diamond MP, Casson PR, Coutifaris C, Barnhart K, Brzyski RG, Schlaff WD, Meacham R, Shin D, Thomas T, Zhang M, Santoro N, Eisenberg E, Zhang H, Network R. Recruitment challenges of a multicenter randomized controlled varicocelectomy trial. Fertility And Sterility 2011, 96: 1299-1305. PMID: 22130101, PMCID: PMC3243664, DOI: 10.1016/j.fertnstert.2011.10.025.Peer-Reviewed Original ResearchMeSH KeywordsAlgorithmsFemaleHumansMaleMulticenter Studies as TopicPatient SelectionRandomized Controlled Trials as TopicResearch DesignUrologic Surgical Procedures, MaleVaricoceleConceptsReproductive Medicine NetworkPlacebo armInfertility evaluationIntrauterine inseminationMedicine NetworkSuboptimal recruitmentClinical trial enrollmentMale infertility studiesAscertain reasonsIUI cyclesInfertile womenTrial enrollmentSurgical interventionPatient educationMAIN OUTCOMEStudy recruitmentInfertile menMale infertilityStudy participantsInfertility studiesMale partnersRecruitment challengesTrialsInadequate recruitmentFertility interventions
2010
Decision trees for identifying predictors of treatment effectiveness in clinical trials and its application to ovulation in a study of women with polycystic ovary syndrome
Zhang H, Legro RS, Zhang J, Zhang L, Chen X, Huang H, Casson PR, Schlaff WD, Diamond MP, Krawetz SA, Coutifaris C, Brzyski RG, Christman GM, Santoro N, Eisenberg E. Decision trees for identifying predictors of treatment effectiveness in clinical trials and its application to ovulation in a study of women with polycystic ovary syndrome. Human Reproduction 2010, 25: 2612-2621. PMID: 20716558, PMCID: PMC2939757, DOI: 10.1093/humrep/deq210.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAndrogensAnovulationBody Mass IndexClomipheneDecision TreesDrug Therapy, CombinationFemaleFertility Agents, FemaleHumansInfertility, FemaleMetforminOrgan SizeOvulation InductionPolycystic Ovary SyndromePregnancyProinsulinRandomized Controlled Trials as TopicSex Hormone-Binding GlobulinTreatment OutcomeWaist-Hip RatioConceptsPolycystic ovary syndromeCombination of CCClomiphene citrateClinical trialsOvarian volumeOvary syndromeOvulation inductionHigher sex hormone-binding globulin levelsSex hormone-binding globulin levelsHormone-binding globulin levelsTreatment effectivenessHigher baseline insulinHip circumference ratioIncidence of ovulationBaseline physical characteristicsBaseline laboratoryOvulatory rateClinical parametersHigher waistBaseline variablesPredictive biomarkersGlobulin levelsCircumference ratioOvulatory responseTreatment outcomes
2006
Longitudinal Effects of Coping on Outcome in a Randomized Controlled Trial of a Group Intervention for HIV-Positive Adults with AIDS-Related Bereavement
Hansen NB, Tarakeshwar N, Ghebremichael M, Zhang H, Kochman A, Sikkema KJ. Longitudinal Effects of Coping on Outcome in a Randomized Controlled Trial of a Group Intervention for HIV-Positive Adults with AIDS-Related Bereavement. Death Studies 2006, 30: 609-636. PMID: 16865824, DOI: 10.1080/07481180600776002.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdaptation, PsychologicalAdultBereavementEthnicityFemaleGriefHIV SeropositivityHumansLongitudinal StudiesMaleNew YorkPsychotherapy, GroupQuality of LifeRandomized Controlled Trials as TopicSexual BehaviorTime FactorsTreatment OutcomeUnited StatesWisconsinConceptsPsychiatric distressHIV-positive adultsHIV-positive participantsOutcome one yearCoping strategiesQuality of lifeMeasures of griefLongitudinal effectsControlled TrialsAvoidant coping strategiesIntervention participantsLongitudinal courseOne-yearGroup interventionOutcome variablesAvoidant copingGreater reductionInterventionAIDSDistressTrialsStudy conditionsCopingGriefParticipants