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 ResearchMeSH KeywordsCatechinChildFemaleFertilityGonadotropin-Releasing HormoneHumansInfertilityLeiomyomaMulticenter Studies as TopicOvulation InductionPregnancyPregnancy RateProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTeaConceptsUnexplained 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
2022
Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial
Taylor H, Li HJ, Carson S, Flores V, Pal L, Robbins J, Santoro NF, Segars JH, Seifer D, Huang H, Young S, Zhang H. Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial. BMJ Open 2022, 12: e052043. PMID: 35715184, PMCID: PMC9207753, DOI: 10.1136/bmjopen-2021-052043.Peer-Reviewed Original ResearchConceptsEndometriosis-associated infertilityPlacebo-controlled trialGnRH antagonistFertility treatmentOral GnRH antagonistEndometriosis-related infertilityFertilization-embryo transferLive birth rateUse of gonadotropinsEtiology of infertilityInstitutional review boardAntagonist pretreatmentCommon complicationObstetrical outcomesPeer-reviewed journalsSecondary outcomesIVF treatmentPrimary outcomeHormone agonistImplantation ratePregnancy rateLive birthsEndometriosisLocal protocolsOocyte number
2020
Pregnancy registry: three-year follow-up of children conceived from letrozole, clomiphene, or gonadotropins
Legro RS, Diamond MP, Coutifaris C, Schlaff WD, Alvero R, Casson P, Christman GM, Rosen RM, Cedars MI, Hansen KR, Robinson R, Baker V, Usadi R, Dodson WC, Estes SJ, Kunselman A, Stetter C, Barnhart KT, Coward RM, Trussell JC, Krawetz SA, Santoro N, Huang H, Zhang H, Eisenberg E, Network R. Pregnancy registry: three-year follow-up of children conceived from letrozole, clomiphene, or gonadotropins. Fertility And Sterility 2020, 113: 1005-1013. PMID: 32386612, PMCID: PMC7376442, DOI: 10.1016/j.fertnstert.2019.12.023.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsChild BehaviorChild DevelopmentChild, PreschoolClomipheneCognitionFemaleFertilityFertility AgentsFollow-Up StudiesGesturesGonadotropinsHumansInfantInfertility, FemaleLetrozoleLive BirthMaleOvulation InductionPolycystic Ovary SyndromePregnancyProspective StudiesRandomized Controlled Trials as TopicRegistriesTreatment OutcomeUnited StatesWeight GainConceptsGN groupMultiple pregnancy rateProspective cohort studyPolycystic ovary syndromeChildren of womenInfertility trialsUnexplained infertilityCohort studyII studyMultiple gestationsOvary syndromeHealth centersInfertility treatmentPregnancy rateInfertility therapyMAIN OUTCOMELTZ groupLetrozoleMacArthur-Bates Communicative Development InventoriesAcademic health centersGonadotropinAbnormal scoresClomipheneCC groupDevelopmental Questionnaire
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 ResearchMeSH KeywordsClinical ProtocolsEthics Committees, ResearchHumansMulticenter Studies as TopicNational Institute of Child Health and Human Development (U.S.)Randomized Controlled Trials as TopicReproductive MedicineTime FactorsUnited StatesConceptsInstitutional 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