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 Research
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 ResearchConceptsInstitutional 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 approvalEvaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation
Barnhart K, Giudice L, Young S, Thomas T, Diamond MP, Segars J, Youssef WA, Krawetz S, Santoro N, Eisenberg E, Zhang H, Network F. Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation. Contemporary Clinical Trials 2018, 68: 1-6. PMID: 29524590, PMCID: PMC5899676, DOI: 10.1016/j.cct.2018.03.002.Peer-Reviewed Original ResearchConceptsReproductive Medicine NetworkDisease-specific questionnaireReproductive-aged womenTime of surgeryEstrogen-dependent conditionStage of endometriosisExtensive clinical evaluationSeverity of diseaseNoninvasive diagnostic biomarkersAcademic medical centerPelvic painEndometrial biopsyNonsurgical diagnosisSerum cytokinesSurgical ablationGynecologic surgeryClinical evaluationClinical reasonsMedical CenterAged womenPharmacological controlEndometriosisGenomic classifierSpecific questionnaireTherapy shifts
2017
Preconceptional antithyroid peroxidase antibodies, but not thyroid-stimulating hormone, are associated with decreased live birth rates in infertile women
Seungdamrong A, Steiner AZ, Gracia CR, Legro RS, Diamond MP, Coutifaris C, Schlaff WD, Casson P, Christman GM, Robinson RD, Huang H, Alvero R, Hansen KR, Jin S, Eisenberg E, Zhang H, Santoro N, Network E. Preconceptional antithyroid peroxidase antibodies, but not thyroid-stimulating hormone, are associated with decreased live birth rates in infertile women. Fertility And Sterility 2017, 108: 843-850. PMID: 29102040, PMCID: PMC8129952, DOI: 10.1016/j.fertnstert.2017.08.026.Peer-Reviewed Original ResearchAnti-TPO antibodiesLive birth rateThyroid-stimulating hormoneAntithyroid peroxidase antibodiesMIU/LInfertile womenClinical pregnancyPeroxidase antibodiesLive birthsReproductive outcomesBirth rateEunice Kennedy Shriver National InstituteMultivariable logistic regression analysisMultivariable logistic regression modelReproductive Medicine NetworkMIU/L.Adverse reproductive outcomesHigher miscarriage ratePoor reproductive outcomesRisk of miscarriageLogistic regression analysisLogistic regression modelsSimilar conception ratesMiscarriage rateTSH levels
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 ResearchConceptsReproductive 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 interventionsIncreasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies
Schlaff WD, Zhang H, Diamond MP, Coutifaris C, Casson PR, Brzyski RG, Christman GM, Barnhart KT, Trussell JC, Krawetz SA, Snyder PJ, Ohl D, Santoro N, Eisenberg E, Huang H, Legro RS, Network R. Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertility And Sterility 2011, 96: 15-18. PMID: 21645894, PMCID: PMC3151556, DOI: 10.1016/j.fertnstert.2011.05.069.Peer-Reviewed Original ResearchConceptsPolycystic Ovary Syndrome IReproductive Medicine NetworkMulticenter clinical trialMulticenter trialClinical trialsSubstantial burdenInstitutional reviewClinical investigatorsMedicine NetworkSignificant increaseBurdenTrialsInstitutional review board requirementsObjective dataIRB submissionPregnancyInfertilityHuman research participantsYearsSignificant variability