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 adherenceEndometrial thickness after ovarian stimulation with gonadotropin, clomiphene, or letrozole for unexplained infertility, and association with treatment outcomes
Quaas AM, Gavrizi SZ, Peck JD, Diamond MP, Legro RS, Robinson RD, Casson P, Christman GM, Zhang H, Hansen KR, Network E. Endometrial thickness after ovarian stimulation with gonadotropin, clomiphene, or letrozole for unexplained infertility, and association with treatment outcomes. Fertility And Sterility 2020, 115: 213-220. PMID: 32972733, PMCID: PMC7796980, DOI: 10.1016/j.fertnstert.2020.07.030.Peer-Reviewed Original ResearchConceptsLive birth rateEndometrial thicknessUnexplained infertilityOvarian stimulationRisk ratioLive birthsEMT groupHuman chorionic gonadotropin administrationHigher live birth rateIntrauterine insemination treatmentMean endometrial thicknessMultiple Intrauterine GestationsOvarian stimulation medicationChorionic gonadotropin administrationProspective cohort analysisUnadjusted risk ratioAdjusted risk ratioBirth rateOS-IUIThin endometriumIntrauterine gestationGonadotropin administrationStimulation medicationsClinical trialsTreatment outcomesIntrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial
Hansen KR, Peck JD, Coward RM, Wild RA, Trussell JC, Krawetz SA, Diamond MP, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson P, Christman GM, Santoro N, Zhang H. Intrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial. Human Reproduction 2020, 35: 1296-1305. PMID: 32432326, PMCID: PMC7316499, DOI: 10.1093/humrep/deaa027.Peer-Reviewed Original ResearchConceptsTotal motile sperm countLive birth rateHigher total motile sperm countUnexplained infertilityMulticentre clinical trialMotile sperm countClinical trialsLive birthsOvarian stimulationHCG injectionBirth ratePatient discomfortSperm countTreatment cyclesSecondary analysisEunice Kennedy Shriver National InstituteSTUDY FUNDING/COMPETINGLive birth successMultiple Intrauterine GestationsDuration of infertilityIUI treatment cyclesLive birth outcomesPARTICIPANTS/MATERIALSROLE OF CHANCEYears of ageAndrogenicity and fertility treatment in women with unexplained infertility
Wang ET, Diamond MP, Alvero R, Casson P, Christman GM, Coutifaris C, Hansen KR, Sun F, Legro RS, Robinson RD, Usadi RS, Pisarska MD, Santoro NF, Zhang H, Network I. Androgenicity and fertility treatment in women with unexplained infertility. Fertility And Sterility 2020, 113: 636-641. PMID: 32192596, PMCID: PMC7088440, DOI: 10.1016/j.fertnstert.2019.10.034.Peer-Reviewed Original ResearchConceptsLive birth rateBody mass indexUnexplained infertilityClinical pregnancyMass indexPregnancy lossClinical markersLive birthsAndrogenic activityFree androgen index valuesHigher body mass indexMultivariable logistic regression modelMultiple Intrauterine GestationsNormal uterine cavityHigh waist circumferenceOvarian stimulation treatmentPatent fallopian tubesBirth rateLogistic regression modelsAndrogen markersSerum TTOvarian stimulationRegular mensesInfertility populationIntrauterine gestation
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
Vitamin 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 ResearchConceptsVitamin 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 dataAllostatic load, a measure of chronic physiological stress, is associated with pregnancy outcomes, but not fertility, among women with unexplained infertility
Barrett ES, Vitek W, Mbowe O, Thurston SW, Legro RS, Alvero R, Baker V, Bates GW, Casson P, Coutifaris C, Eisenberg E, Hansen K, Krawetz S, Robinson R, Rosen M, Usadi R, Zhang H, Santoro N, Diamond M. Allostatic load, a measure of chronic physiological stress, is associated with pregnancy outcomes, but not fertility, among women with unexplained infertility. Human Reproduction 2018, 33: 1757-1766. PMID: 30085177, PMCID: PMC6454470, DOI: 10.1093/humrep/dey261.Peer-Reviewed Original ResearchConceptsAdverse pregnancy outcomesOvarian stimulationPreterm birthPregnancy outcomesLive birthsUnexplained infertilityLipoprotein cholesterolBlood pressureBirth outcomesLow birthweightAllostatic loadSpontaneous abortionReproductive outcomesHigh-density lipoprotein cholesterolLow-density lipoprotein cholesterolAL scoreSTUDY FUNDING/COMPETINGChronic physiological stressMulti-variable logistic regression modelAdvanced Reproductive CareMultiple Intrauterine GestationsDiastolic blood pressureNon-pregnant stateSystolic blood pressureType of infertilityMidluteal Progesterone: A Marker of Treatment Outcomes in Couples With Unexplained Infertility
Hansen KR, Eisenberg E, Baker V, Hill MJ, Chen S, Talken S, Diamond MP, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson P, Christman GM, Santoro N, Zhang H, Wild RA, Network N. Midluteal Progesterone: A Marker of Treatment Outcomes in Couples With Unexplained Infertility. The Journal Of Clinical Endocrinology & Metabolism 2018, 103: 2743-2751. PMID: 29767754, PMCID: PMC6276712, DOI: 10.1210/jc.2018-00642.Peer-Reviewed Original ResearchConceptsMidluteal progesterone levelsUnexplained infertilityLive birthsOS-IUIProgesterone levelsPregnancy outcomesClinical trialsTreatment groupsIntrauterine insemination treatmentMultiple Intrauterine GestationsOvarian stimulation medicationSuccessful pregnancy outcomeMulticenter clinical trialLow progesterone levelsMidluteal progesteroneClomiphene citrateOvarian stimulationIntrauterine gestationEndometrial changesPathophysiologic mechanismsGonadotropin treatmentStimulation medicationsProgesterone exposureTreatment outcomesProgesterone concentrations
2017
Sexual function in infertile women with polycystic ovary syndrome and unexplained infertility
Diamond MP, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson PA, Christman GM, Huang H, Hansen KR, Baker V, Usadi R, Seungdamrong A, Bates GW, Rosen RM, Schlaff W, Haisenleder D, Krawetz SA, Barnhart K, Trussell JC, Santoro N, Eisenberg E, Zhang H, Network E. Sexual function in infertile women with polycystic ovary syndrome and unexplained infertility. American Journal Of Obstetrics And Gynecology 2017, 217: 191.e1-191.e19. PMID: 28455078, PMCID: PMC5657185, DOI: 10.1016/j.ajog.2017.04.034.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeFemale Sexual Function InventoryUnexplained infertilityOvary syndromeSexual Function InventorySexual functionInfertile womenSexual dysfunctionEunice Kennedy Shriver National InstituteFemale Sexual Distress ScaleTotal scoreMultiple Intrauterine GestationsFree androgen indexReproductive-age womenSexual function scoresBody mass indexFemale sexual functionFemale sexual dysfunctionSexual Distress ScaleScale total scoreAndrogenic manifestationsAndrogen indexOvarian stimulationAndrogen excessIntrauterine gestationAssociation of uterine fibroids and pregnancy outcomes after ovarian stimulation–intrauterine insemination for unexplained infertility
Styer AK, Jin S, Liu D, Wang B, Polotsky AJ, Christianson MS, Vitek W, Engmann L, Hansen K, Wild R, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson P, Christman GM, Christy A, Diamond MP, Eisenberg E, Zhang H, Santoro N, Network I. Association of uterine fibroids and pregnancy outcomes after ovarian stimulation–intrauterine insemination for unexplained infertility. Fertility And Sterility 2017, 107: 756-762.e3. PMID: 28089575, PMCID: PMC5472203, DOI: 10.1016/j.fertnstert.2016.12.012.Peer-Reviewed Original ResearchMeSH KeywordsAbortion, SpontaneousAdultBlack or African AmericanDrug Therapy, CombinationFemaleFertilityFertility AgentsHumansInfertilityInsemination, ArtificialLeiomyomaLive BirthOvulationOvulation InductionPregnancyPregnancy RatePregnancy TestsProspective StudiesRisk FactorsTreatment OutcomeUnited StatesUterine NeoplasmsConceptsUnexplained infertilityUterine fibroidsPregnancy outcomesClinical trialsSerum antimüllerian hormone levelsBirth rateNon-African American womenGreater uterine volumeMultiple Intrauterine GestationsNormal uterine cavityClinical pregnancy rateAntimüllerian hormone levelsMulticenter clinical trialAmerican womenAfrican American womenClinical pregnancyIntrauterine gestationUterine volumeConception cyclesUterine cavityPregnancy lossHormone levelsPregnancy rateAntral folliclesMAIN OUTCOME
2016
Fertility-related quality of life from two RCT cohorts with infertility: unexplained infertility and polycystic ovary syndrome
Santoro N, Eisenberg E, Trussell JC, Craig LB, Gracia C, Huang H, Alvero R, Casson P, Christman G, Coutifaris C, Diamond M, Jin S, Legro RS, Robinson RD, Schlaff WD, Zhang H. Fertility-related quality of life from two RCT cohorts with infertility: unexplained infertility and polycystic ovary syndrome. Human Reproduction 2016, 31: 2268-2279. PMID: 27402910, PMCID: PMC5027926, DOI: 10.1093/humrep/dew175.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeFertility-related qualityFertiQoL scoresUnexplained infertilityPregnancy outcomesLower QoLOvary syndromeMale partnersInfertility diagnosisQOL surveyFerring PharmaceuticalsWorldwide cohortPolycystic Ovary Syndrome IIWilcoxon rank-sum testingFirst patient enrollmentMultiple Intrauterine GestationsTime of enrollmentPARTICIPANTS/MATERIALSRank-sum testingNational InstitutePopulation-based sampleROLE OF CHANCEKey participant characteristicsLow socioeconomic statusHirsutism scorePredictors of pregnancy and live-birth in couples with unexplained infertility after ovarian stimulation–intrauterine insemination
Hansen KR, He AL, Styer AK, Wild RA, Butts S, Engmann L, Diamond MP, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson P, Christman GM, Huang H, Santoro N, Eisenberg E, Zhang H, Network E. Predictors of pregnancy and live-birth in couples with unexplained infertility after ovarian stimulation–intrauterine insemination. Fertility And Sterility 2016, 105: 1575-1583.e2. PMID: 26949110, PMCID: PMC4893990, DOI: 10.1016/j.fertnstert.2016.02.020.Peer-Reviewed Original ResearchConceptsDuration of infertilityUnexplained infertilityPregnancy outcomesClinical trialsClinical pregnancyBaseline characteristicsLive birthsMultivariable logistic regression analysisMultiple Intrauterine GestationsMultiple pregnancy ratePredictors of pregnancyPrior pregnancy lossLive birth rateMulticenter clinical trialSignificant predictorsLogistic regression analysisClomiphene citrateOvarian stimulationAntimüllerian hormoneIntrauterine gestationSerum levelsWaist circumferencePregnancy lossObstetrical carePregnancy rate
2015
Chlamydia trachomatis immunoglobulin G3 seropositivity is a predictor of reproductive outcomes in infertile women with patent fallopian tubes
Steiner AZ, Diamond MP, Legro RS, Schlaff WD, Barnhart KT, Casson PR, Christman GM, Alvero R, Hansen KR, Geisler WM, Thomas T, Santoro N, Zhang H, Eisenberg E, Network R. Chlamydia trachomatis immunoglobulin G3 seropositivity is a predictor of reproductive outcomes in infertile women with patent fallopian tubes. Fertility And Sterility 2015, 104: 1522-1526. PMID: 26413816, PMCID: PMC4663111, DOI: 10.1016/j.fertnstert.2015.08.022.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntibodies, BacterialBiomarkersChi-Square DistributionChlamydia InfectionsChlamydia trachomatisEnzyme-Linked Immunosorbent AssayFallopian TubesFemaleHumansImmunoglobulin GInfertility, FemaleLinear ModelsLive BirthMultivariate AnalysisOdds RatioPredictive Value of TestsPregnancyPregnancy RatePregnancy, EctopicReproductive Techniques, AssistedRisk AssessmentRisk FactorsSerologic TestsTreatment OutcomeUltrasonographyYoung AdultConceptsEctopic pregnancySeropositive womenInfertile womenTubal patencyLive birthsPolycystic Ovary Syndrome IIChlamydia trachomatis seropositivityMultiple Intrauterine GestationsPatent fallopian tubesEnzyme-linked immunosorbentCurrent alcohol useC. trachomatis elementary bodiesOvarian stimulationCohort studyIntrauterine gestationPregnancy outcomesPrimary outcomeTreatment medicationsPatent tubesSmoking statusOutpatient clinicIgG3 antibodiesFallopian tubeRelative riskMAIN OUTCOMERecruitment strategies in two reproductive medicine network infertility trials
Usadi RS, Diamond MP, Legro RS, Schlaff WD, Hansen KR, Casson P, Christman G, Bates G, Baker V, Seungdamrong A, Rosen MP, Lucidi S, Thomas T, Huang H, Santoro N, Eisenberg E, Zhang H, Alvero R, Network F. Recruitment strategies in two reproductive medicine network infertility trials. Contemporary Clinical Trials 2015, 45: 196-200. PMID: 26386293, PMCID: PMC4766588, DOI: 10.1016/j.cct.2015.09.010.Peer-Reviewed Original ResearchConceptsPPCOS IIMultiple Intrauterine GestationsPolycystic ovary syndromeRecruitment strategiesSuccessful recruitment strategiesInfertility trialsOvarian stimulationIntrauterine gestationOvary syndromeWhite patientsBlack patientsDifferent recruitment strategiesPhysician referralClinical trialsInfertile couplesTrial completionClinical sitesTrialsRecruitment methodsPatientsSimilar ratesPhysiciansWomenParticipantsSuccessful strategyMale obesity is an independent risk factor for treatment failure among couples with unexplained infertility in the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial
Polotsky A, Allshouse A, Krawetz S, Santoro N, Eisenberg E, Zhang H, Diamond M. Male obesity is an independent risk factor for treatment failure among couples with unexplained infertility in the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial. Fertility And Sterility 2015, 104: e78. DOI: 10.1016/j.fertnstert.2015.07.238.Peer-Reviewed Original ResearchAssessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics
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, Haisonleder D, Krawetz SA, Barnhart K, Trussell JC, Jin Y, Santoro N, Eisenberg E, Zhang H, Network I. Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics. Fertility And Sterility 2015, 103: 962-973.e4. PMID: 25707331, PMCID: PMC4529113, DOI: 10.1016/j.fertnstert.2014.12.130.Peer-Reviewed Original ResearchConceptsAntimüllerian hormone levelsAntral follicle countBody mass indexBaseline characteristicsClomiphene citrateOvarian stimulationUnexplained infertilityFollicle countHormone levelsSemen parametersMean body mass indexGood ovarian reserveMultiple Intrauterine GestationsOvarian stimulation (AMIGOS) trialUse of letrozoleComparable patient populationsProspective clinical trialsCause of infertilityOvulation induction medicationsRate of multiplesCommon baseline characteristicsNormal semen parametersBasal FSHInfertility durationBaseline demographics
2011
Estimating rates of multiple gestation pregnancies: Sample size calculation from the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial
Diamond MP, Mitwally M, Casper R, Ager J, Legro RS, Brzyski R, Casson P, Eisenberg E, Zhang H, Network F. Estimating rates of multiple gestation pregnancies: Sample size calculation from the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial. Contemporary Clinical Trials 2011, 32: 902-908. PMID: 21787883, PMCID: PMC3708642, DOI: 10.1016/j.cct.2011.07.009.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAromatase InhibitorsClomipheneDose-Response Relationship, DrugDouble-Blind MethodFemaleFertility Agents, FemaleGonadotropinsHumansInfant, NewbornInfertilityLetrozoleMaleNitrilesOvulation InductionPregnancyPregnancy OutcomePregnancy, MultipleProspective StudiesTreatment OutcomeTriazolesYoung AdultConceptsMultiple Intrauterine GestationsMultiple gestation pregnanciesOvulation inductionUnexplained infertilityGestation pregnanciesIntrauterine gestationMultiple gestationsComparable pregnancy ratesMono-follicular developmentOvarian stimulation (AMIGOS) trialOvarian hyperstimulation syndromePregnancy success ratePublic health benefitsExpense of careHyperstimulation syndromeClomiphene citrateNeonatal morbidityPreterm laborFertility medicationsPreterm infantsIntrauterine inseminationStimulation trialsAromatase inhibitorsPregnancy rateGestation