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 adherenceIntrauterine 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 age
2018
Effect of exposure to second-hand smoke from husbands on biochemical hyperandrogenism, metabolic syndrome and conception rates in women with polycystic ovary syndrome undergoing ovulation induction
Li J, Wu Q, Wu XK, Zhou ZM, Fu P, Chen XH, Yan Y, Wang X, Yang ZW, Li WL, Stener-Victorin E, Legro RS, Ng EH, Zhang H, Mol BWJ, Wang CC, Group F. Effect of exposure to second-hand smoke from husbands on biochemical hyperandrogenism, metabolic syndrome and conception rates in women with polycystic ovary syndrome undergoing ovulation induction. Human Reproduction 2018, 33: 617-625. PMID: 29471520, DOI: 10.1093/humrep/dey027.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeNon-exposed womenSHS exposure statusSHS exposureMetabolic syndromeBiochemical hyperandrogenismObstetric outcomesOvary syndromeOvulation inductionSex hormonesExposure statusHigher serum total testosteroneSecond-hand smoke exposureSTUDY FUNDING/COMPETINGConception rateLower sex hormoneFree androgen indexSerum total testosteroneUterine blood flowLive birth rateNon-exposed groupSecond-hand smokePARTICIPANTS/MATERIALSROLE OF CHANCEAndrogen index
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 score
2015
Identification 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 ResearchConceptsPolycystic 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
2014
Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype
Legro RS, Chen G, Kunselman AR, Schlaff WD, Diamond MP, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Zhang H, Foulds J, Barnhart K, Martino L, Timbers K, Lambe L, DeWire R, Yang H, Bodine C, Mark D, Puscheck E, Ginsburg K, Collins K, Brossoit M, Leach R, Yelian F, Perez M, Buster J, Amato P, Torres M, Dodson W, Gnatuk C, Ober J, Demers L, Heller D, Colon J, Weiss G, Solnica A, Gatlin K, Hahn S, Roark M, Blackwell R, Willis V, Love L, Laychak K, Nazmy M, Stovall D, Evans W, Turner K, Chang J, Malcolm P, Coddington C, Permanente K, Faber K, Hasenleider D, Huang H. Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype. Human Reproduction 2014, 29: 2680-2686. PMID: 25324541, PMCID: PMC4227579, DOI: 10.1093/humrep/deu239.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeSerum cotinine levelsCase-control studySmoking statusInfertility treatmentCotinine levelsPast smokersCurrent smokersOvary syndromeInfertile womenInsulin resistanceFirst-line ovulation induction agentsMulti-center clinical trialOvulation induction agentsWorse insulin resistanceTotal testosterone levelsLive birth rateSecond-hand smokePARTICIPANTS/MATERIALSNational InstituteROLE OF CHANCESelf-reported changesHirsutism scoreSmoking groupRecent smokers