[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592781":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":27,"responsibleParty":57,"collaborators":59,"id":62,"slug":11,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Clinique Ovo","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Follitropin delta and HP-hMG","EXPERIMENTAL",null,[13],"Drug: Combination therapy : Follitropin delta and HP-hMG",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Combination therapy : Follitropin delta and HP-hMG","Follitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Marya Far","CONTACT","514-798-2000","759","m.far@cliniqueovo.com",[28,44],{"facility":29,"status":30,"city":31,"state":32,"zip":11,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Ottawa fertility centre","RECRUITING","Ottawa","Ontario","Canada",{"type":35,"coordinates":36},"Point",[37,38],-75.69812,45.41117,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":11,"phoneExt":11,"email":11},"Jenna Gale, MD","PRINCIPAL_INVESTIGATOR",{"facility":45,"status":30,"city":46,"state":47,"zip":48,"country":33,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Clinique ovo","Montreal","Quebec","H4P 2S4",{"type":35,"coordinates":50},[51,52],-73.58781,45.50884,{"lat":52,"lon":51},[55],{"name":56,"role":43,"phone":11,"phoneExt":11,"email":11},"Isaac-Jacques Kadoch, MD",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[60],{"name":61,"class":6},"Ferring Pharmaceuticals","100592781",false,"NCT06997900","Menopur And Rekovelle Combination Study Version 2.0","MARCS 2","Inclusion Criteria:\n\n* Women aged 18 to 40 years inclusively at the time of consent form signature\n* Diagnosis of unexplained infertility, tubal infertility, endometriosis stage I\u002FII or male factor infertility\n* Regular menstrual cycles of 24-35 days\n* Presence of both ovaries\n* Early follicular phase FSH serum concentration \\\u003C10 IU\u002FL measured between Day 2 and Day 5 of menstrual cycle within the previous 24 months\n* First IVF\u002FICSI cycle\n* IVF antagonist protocol prescribed\n* Partner or donor ejaculated sperm (fresh or frozen) used for fertilization\n\nExclusion Criteria:\n\n* Women undergoing oocyte donation\n* Endometriosis stage III\u002FIV\n* High risk of OHSS (AMH ≥ 35 pmol\u002FL)\n* Body Mass Index (BMI) \\> 40 kg\u002Fm2 Protocol number: IIS-1056 MARCS 2.0 Study Version: 1.1 - Date : 14 APR 2025 Page 12 of 28\n* Gynaecological haemorrhages of unknown aetiology\n* History of recurrent miscarriages defined as ≥ 3 consecutive losses\n* Renal or hepatic impairment\n* Hypersensitivity to any active ingredient or excipients in follitropin delta and\u002For HP-hMG\n* Tumours of hypothalamus or pituitary gland\n* Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome\n* Current or history of ovarian, uterine or mammary carcinoma\n* History of thrombophilia\n* Use of hormonal preparations (except for 17β-estradiol, testosterone gel, DHEA and thyroid medication) during the last menstrual cycle\n* Women participating in any other interventional research project","FEMALE","18 Years","40 Years",{"count":72,"type":73},200,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is:\n\n\\- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ?\n\nResearchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes\n\nParticipants will:\n\n* Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight\n* Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels\n* Undergo standard IVF procedures including egg retrieval and embryo assessment",[79,80,81],"IVF","Controlled Ovarian Simulation","Fertility Disorders","2025-07-29",{"date":84,"type":85},"2025-07-31","ACTUAL",{"date":87,"type":85},"2025-07-04",{"date":89,"type":73},"2027-08",{"name":5,"class":6},2]