[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491295":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":56,"locations":65,"responsibleParty":171,"collaborators":174,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":187,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":198,"studyType":199,"phases":10,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Colorectal endometriosis patients",null,"Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF\u002FICSI or laparoscopic resection of (colorectal) endometriosis.",[13,14],"Procedure: Laparoscopic excision of endometriosis, including colorectal endometriosis","Procedure: In vitro fertilisation or intracytoplasmic sperm injection",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"PROCEDURE","Laparoscopic excision of endometriosis, including colorectal endometriosis","Laparoscopic resection of deep endometriosis, including colorectal endometriosis, in a (candidate) level 2 centre of expertise. Complete resection can exist of either 'shaving' of the nodule from the bowel (leaving the lumen closed), discoid excision or segmental resection, depending on the nodule size and extent of disease.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"In vitro fertilisation or intracytoplasmic sperm injection","IVF\u002FICSI treatment trajectory (maximum of 3 cycles), according to the local protocol. Preferably preceded by 3 months downregulation with either Gonadotrophin-releasing hormone (GnRH) analogue or oral contraceptive pill. One IVF\u002FICSI cycle is defined as the transfer of all the embryos created after one follicle puncture until pregnancy confirmation or failure of the last embryo transfer.",[9],[26,30,33,36,39,42,45,48,50,53],{"name":27,"affiliation":28,"role":29},"Mathijs D. Blikkendaal, MD, PhD","Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":32},"Andries RH Twijnstra, MD, PhD","STUDY_CHAIR",{"name":34,"affiliation":35,"role":32},"Astrid EP Cantineau, MD, PhD","University Medical Center Groningen",{"name":37,"affiliation":38,"role":32},"Jacques Maas, MD, PhD","Maastricht University Medical Center",{"name":40,"affiliation":41,"role":32},"Annemiek Nap, MD, PhD","Radboud University Medical Center",{"name":43,"affiliation":44,"role":32},"Dana Huppelschoten","Catharina Ziekenhuis",{"name":46,"affiliation":47,"role":32},"Simone Broer","UMC Utrecht",{"name":49,"affiliation":28,"role":32},"Tobias Limperg",{"name":51,"affiliation":52,"role":32},"Yvonne Louwers","Erasmus Medical Center",{"name":54,"affiliation":55,"role":32},"Marieke Verberg","Medisch Spectrum Twente",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Mathijs D. Blikkendaal, MD,PhD","CONTACT","088 979 44 89","M.Blikkendaal@rdgg.nl",{"name":63,"role":59,"phone":10,"phoneExt":10,"email":64},"Rozemarijn de Koning, MD","r.de_koning@lumc.nl",[66,79,89,99,109,119,130,140,151,161],{"facility":44,"status":67,"city":68,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Eindhoven","Netherlands","NL",{"type":72,"coordinates":73},"Point",[74,75],5.47778,51.44083,{"lat":75,"lon":74},[78],{"name":43,"role":59,"phone":10,"phoneExt":10,"email":10},{"facility":80,"status":67,"city":81,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Medical Spectrum Twente","Enschede",{"type":72,"coordinates":83},[84,85],6.89583,52.21833,{"lat":85,"lon":84},[88],{"name":54,"role":59,"phone":10,"phoneExt":10,"email":10},{"facility":35,"status":67,"city":90,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Groningen",{"type":72,"coordinates":92},[93,94],6.56667,53.21917,{"lat":94,"lon":93},[97],{"name":98,"role":59,"phone":10,"phoneExt":10,"email":10},"Astrid Cantineau",{"facility":5,"status":67,"city":100,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Leiden",{"type":72,"coordinates":102},[103,104],4.49306,52.15833,{"lat":104,"lon":103},[107],{"name":108,"role":59,"phone":10,"phoneExt":10,"email":10},"Dries Twijnstra",{"facility":38,"status":67,"city":110,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Maastricht",{"type":72,"coordinates":112},[113,114],5.68889,50.84833,{"lat":114,"lon":113},[117],{"name":118,"role":59,"phone":10,"phoneExt":10,"email":10},"Jacques Maas",{"facility":120,"status":67,"city":121,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Radboud university medical center","Nijmegen",{"type":72,"coordinates":123},[124,125],5.85278,51.8425,{"lat":125,"lon":124},[128],{"name":129,"role":59,"phone":10,"phoneExt":10,"email":10},"Annemiek Nap",{"facility":131,"status":67,"city":132,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Erasmus Medical Centre","Rotterdam",{"type":72,"coordinates":134},[135,136],4.47917,51.9225,{"lat":136,"lon":135},[139],{"name":51,"role":59,"phone":10,"phoneExt":10,"email":10},{"facility":141,"status":67,"city":142,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Haaglanden Medical Center","The Hague",{"type":72,"coordinates":144},[145,146],4.29861,52.07667,{"lat":146,"lon":145},[149],{"name":150,"role":59,"phone":10,"phoneExt":10,"email":10},"Moniek van der Zanden",{"facility":152,"status":67,"city":153,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Utrecht Medical Center","Utrecht",{"type":72,"coordinates":155},[156,157],5.12222,52.09083,{"lat":157,"lon":156},[160],{"name":46,"role":59,"phone":10,"phoneExt":10,"email":10},{"facility":162,"status":67,"city":163,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)","Voorburg",{"type":72,"coordinates":165},[166,167],4.35972,52.07417,{"lat":167,"lon":166},[170],{"name":49,"role":59,"phone":10,"phoneExt":10,"email":10},{"type":29,"investigatorFullName":172,"investigatorTitle":173,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"mdblikkendaal","Principle Investigator",[175,177,178,179,180,182,184],{"name":176,"class":6},"Haaglanden Medical Centre",{"name":35,"class":6},{"name":38,"class":6},{"name":41,"class":6},{"name":181,"class":6},"Reinier de Graaf Groep",{"name":183,"class":6},"Catharina Ziekenhuis Eindhoven",{"name":47,"class":6},"100491295","the-cost-effectiveness-of-surgical-excision-of-colorectal-endometriosis-compared-to-art-treatment-trajectory-100491295",false,"NCT05677269","The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory","TOSCA","Inclusion Criteria:\n\n* Colorectal endometriosis defined as endometriosis involving the (colo)rectum:\n\n  #Enzian classification score C1,C2,C3 (C=rectum) or FI (F=far locations, I=sigmoid colon) detected with ultrasound or MRI;\n* Women in a heterosexual or in a same-sex relationship;\n* The patient has an active wish to conceive and experiences at least one of the following criteria:\n\n  * At least one year of non-conception (either spontaneous of after intra uterine inseminations)\n  * Inability to have timed intercourse because of pain (dyspareunia and\u002For chronic pelvic pain)\n  * Severe complaints (expectant management is not acceptable (anymore)\n* The patients has an indication for IVF\u002FICSI according to Dutch guidelines (Werkgroep netwerkrichtlijn, december 2010);\n\n  * failed intra uterine insemination\n  * male factor subfertility (oligoasthenoteratozoospermia defined as VCM \\\u003C1 million)\n  * bilateral tubal pathology (e.g. bilateral hydrosalpinx, bilateral tubal occlusion)\n  * age \\> 38 years and (unexplained) subfertility\n  * severe endometriosis in case of subfertility\n* The patient is faces the choice between IVF\u002FICSI or laparoscopic (colorectal) endometriosis or is on the waiting list for a respective treatment at T=0 (at the beginning of the treatment trajectory), T=1 (after one unsuccessful IVF\u002FICSI cycle) or T=2 (after 2 unsuccessful IVF\u002FICSI cycles)\n\nExclusion Criteria:\n\n* Patients with deep endometriosis without colorectal involvement;\n* Patients who conceive spontaneously prior to intervention;\n* Patients requiring surgery on short notice and therefore unable to opt for IVF\u002FICSI (e.g. in case of unilateral or bilateral hydronephrosis, severe bowel stenosis and suspicion of an impending ileus);\n* Patients with a contra-indication for IVF\u002FICSI (e.g. diminished ovarian reserve (premature ovarian failure) (AMH (when available) \\\u003Cp10 adjusted for age), untreated congenital uterine abnormalities, maltreated\u002Funtreated systemic or malignant disease or severe risk factors for oocyte aspiration);\n* Patients diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome);\n* Not able to read and understand Dutch or English.","FEMALE","21 Years","40 Years",{"count":196,"type":197},339,"ESTIMATED","40 Months","OBSERVATIONAL","To goal of this study is to determine whether laparoscopic resection of colorectal endometriosis results in an increased cumulative live birth rate (CLBR) both spontaneous and after ART (including in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and better patient reported outcome measures (PROMs) compared to an IVF\u002FICSI treatment trajectory.",[202,203,204],"Endometriosis, Rectum","Endometriosis of Colon","Subfertility, Female",[206,207,208,209,210,211,212],"Colorectal endometriosis","Subfertility","Surgery","In vitro fertilisation","Live birth rate","Quality of life","Cost-effectiveness","2024-11-19",{"date":215,"type":216},"2024-11-21","ACTUAL",{"date":218,"type":216},"2023-02-17",{"date":220,"type":197},"2029-01-01",{"name":5,"class":6},10]