2024
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
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 ResearchConceptsUnexplained 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 ResearchConceptsPolycystic 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 adherence
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 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 approval
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