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
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 scoreVitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial
Pal L, Zhang H, Williams J, Santoro NF, Diamond MP, Schlaff WD, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers E, Legro RS, Network F. Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. The Journal Of Clinical Endocrinology & Metabolism 2016, 101: 3027-3035. PMID: 27186859, PMCID: PMC4971341, DOI: 10.1210/jc.2015-4352.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeLive birthsVitD statusOvary syndromeSerum 25OHDIndependent predictorsSecondary analysisOvulation induction outcomesSerum 25OHD levelsVitamin D statusHealth diagnostic criteriaD statusNonpregnant populationRetrospective cohortControlled TrialsVitamin DPregnancy lossReproductive outcomesDiagnostic criteriaTrial dataProgressive improvementWomenInduction outcomeNational InstituteSyndrome
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