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
2023
Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women
Siblini H, Al-Hendy A, Segars J, González F, Taylor H, Singh B, Flaminia A, Flores V, Christman G, Huang H, Johnson J, Zhang H. Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women. Nutrients 2023, 15: 320. PMID: 36678191, PMCID: PMC9861948, DOI: 10.3390/nu15020320.Peer-Reviewed Original ResearchMeSH KeywordsAdultCatechinClomipheneFemaleFolic AcidHumansInfertilityLeiomyomaLetrozoleLiverProspective StudiesTeaConceptsReproductive-aged womenLiver function testsUterine fibroidsUnexplained infertilityClomiphene citrateSerum liver function testsEpigallocatechin gallateSigns of drugSerum folate levelsGreen tea catechinsHepatic safetyPremenopausal womenProspective cohortDaily doseLiver injuryFunction testsTreatment armsLiver toxicityClinical studiesCommon causeFolate levelsEarly safety assessmentInterim analysisNormal rangeUse of EGCG
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
2017
Effects of Oral vs Transdermal Estrogen Therapy on Sexual Function in Early Postmenopause: Ancillary Study of the Kronos Early Estrogen Prevention Study (KEEPS)
Taylor HS, Tal A, Pal L, Li F, Black DM, Brinton EA, Budoff MJ, Cedars MI, Du W, Hodis HN, Lobo RA, Manson JE, Merriam GR, Miller VM, Naftolin F, Neal-Perry G, Santoro NF, Harman SM. Effects of Oral vs Transdermal Estrogen Therapy on Sexual Function in Early Postmenopause: Ancillary Study of the Kronos Early Estrogen Prevention Study (KEEPS). JAMA Internal Medicine 2017, 177: 1471-1479. PMID: 28846767, PMCID: PMC5710212, DOI: 10.1001/jamainternmed.2017.3877.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, CutaneousAdministration, OralAdultDouble-Blind MethodEstradiolEstrogen Replacement TherapyEstrogensEstrogens, Conjugated (USP)FemaleFollow-Up StudiesGlucuronatesHumansMiddle AgedPostmenopauseProgesteroneProgestinsProspective StudiesPsychiatric Status Rating ScalesQuality of LifeRisk FactorsSexual Dysfunction, PhysiologicalTime FactorsWomen's HealthConceptsKronos Early Estrogen Prevention StudyLow sexual functionTransdermal estrogen therapySexual functionAncillary studiesEstrogen therapyPostmenopausal womenPrevention StudyT-E2Female Sexual Function InventoryOral conjugated equine estrogenOverall scoreLower FSFI scoresEarly postmenopausal womenMenopausal hormone therapyPlacebo-controlled trialOral micronized progesteroneConjugated equine estrogensSexual Function InventoryLast menstrual periodEffects of OralQuality of lifeProportion of womenSymptoms of distressMicronized progesterone