2024
Uterine fibroid–related infertility: mechanisms and management
Donnez J, Taylor H, Marcellin L, Dolmans M. Uterine fibroid–related infertility: mechanisms and management. Fertility And Sterility 2024, 122: 31-39. PMID: 38453041, DOI: 10.1016/j.fertnstert.2024.02.049.Peer-Reviewed Original ResearchUterine artery embolizationUterine fibroidsAssociation of fibroidsAdd-back therapyHeavy menstrual bleedingBaseline to weekOral GnRH antagonistPresence of fibroidsNon-surgical approachFocused ultrasoundFibroid volumeMyoma volumeArtery embolizationMenstrual bleedingCurrent management strategiesGnRH antagonistEchographic guidanceSurgical interventionFibroidsInfertilityMedical treatmentUterineWomenOptimal dosageSource of controversyFibroids 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 ResearchConceptsReproductive-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
2022
Linzagolix With and Without Hormonal Add-Back Therapy for the Treatment of Symptomatic Uterine Fibroids: Two Randomized, Placebo-Controlled, Phase 3 Trials
Donnez J, Taylor H, Stewart E, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland J, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix With and Without Hormonal Add-Back Therapy for the Treatment of Symptomatic Uterine Fibroids: Two Randomized, Placebo-Controlled, Phase 3 Trials. Obstetrical & Gynecological Survey 2022, 77: 741-742. DOI: 10.1097/ogx.0000000000001113.Peer-Reviewed Original ResearchPost-treatment Efficacy and Safety Follow-up in Women with Uterine Fibroids Treated for 52 Weeks With Linzagolix [A108]
Taylor H, Donnez J, Bestel E, Humberstone A, Garner E. Post-treatment Efficacy and Safety Follow-up in Women with Uterine Fibroids Treated for 52 Weeks With Linzagolix [A108]. Obstetrics And Gynecology 2022, 139: 31s-32s. DOI: 10.1097/01.aog.0000826752.16466.97.Peer-Reviewed Original ResearchBone mineral densityUterine fibroidsWeek 64Placebo-controlled phase 3 trialLumbar spine bone mineral densityTreatment of UFsSpine bone mineral densityHeavy menstrual bleedingPhase 3 trialWeeks of dosingHealth-related qualityCompletion of treatmentTreatment of womenEfficacy endpointPost-treatment efficacyTreatment discontinuationUterine bleedingWeek 52Key efficacyWeek 76Menstrual bleedingFibroid volumeMedian timeFollow-upMineral densityQuality of Life Improvements in Women with Uterine Fibroids: Results of Two Phase 3 Trials with Linzagolix [A107]
Al-Hendy A, Bradley L, Taylor H, Catherino W, Humberstone A, Garner E. Quality of Life Improvements in Women with Uterine Fibroids: Results of Two Phase 3 Trials with Linzagolix [A107]. Obstetrics And Gynecology 2022, 139: 31s-31s. DOI: 10.1097/01.aog.0000826748.26150.66.Peer-Reviewed Original ResearchPhase 3 trialUterine fibroidsPlacebo-controlled phase 3 trialTreatment of UFsFibroid-related symptomsHealth-related qualifyOral GnRH antagonistHealth-related qualityEnd of treatmentLong-term impairmentSubstantial beneficial effectPlacebo groupGnRH antagonistLife QuestionnaireSexual functionWeek 64Mean changeFrequent causeTreatment terminationEstradiol suppressionTreatment groupsLinzagolixPooled populationBeneficial effectsTotal scoreIncidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix [A104]
Al-Hendy A, Taylor H, Catherino W, Stewart E, Bestel E, Garner E. Incidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix [A104]. Obstetrics And Gynecology 2022, 139: 30s-30s. DOI: 10.1097/01.aog.0000826736.08037.1b.Peer-Reviewed Original ResearchPhase 3 trialUterine fibroidsGnRH antagonistHair lossPlacebo-controlled phase 3 trialUterine fibroid-related symptomsFibroid-related symptomsIncidence of alopeciaOral GnRH antagonistPooled safety analysisTreatment of womenConcomitant therapyTreatment discontinuationStudy drugWeek 52Mild alopeciaWeek 24Benign disorderSimilar incidenceLinzagolixSuppression dosesAlopeciaFibroidsTrialsTreatment