[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602303":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":102,"collaborators":106,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":30,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":30,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":141,"whyStopped":30,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Dunamenti REK Istenhegyi IVF Center","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"Control group","In this arm the hypo-responder patient will undergo stimulation using the same gonadotropin dose as in her previous treatment.\n\nTreatment steps:\n\n1. Stimulation using the same recombinant FSH dose as in her prevoius cycle is started on day 2 or 3 of the menstrual cycle and is continued for 5 days. On day 6 the patient is seen for US and bloodwork. If indicated the dose can be increased by max. 75 IU every 2 days to a maximum of 300 IU\u002Fday.\n2. GnRH antagonist is started at follicle size 12-14 m.\n3. Trigger is administered once the largest follicle gets \\>17 mm. Retrieval is scheduled 36 hrs later. IVF or ICSI fertilization. Luteal support from day past retrieval.\n4. Transfer of 1-2 embryos on day 3 or 5.\n5. Pregnancy test 12 days after ET.",[12],"Drug: unchanged dose",{"label":14,"type":15,"description":16,"interventionNames":17},"Additional LH group (Pergoveris, Merck)","ACTIVE_COMPARATOR","In this arm the hypo-responder patient will undergo stimulation using the same gonadotropin dose as in her previous treatment but in the form of rec FSH and recLH 2:1 ratio (e.g.: if 150 IU rec FSH was used then 150 IU recFSH and recLH (2:1 ratio).\n\nTreatment steps:\n\n1. Stimulation using the same dose as in her previuos cycle but in the form of recombinant FSH and recombinant LH 2:1 ratio is started on day 2 or 3 of the menstrual cycle and is continued for 5 days. On day 6 the patient is seen for US and bloodwork. If indicated the dose can be increased by max. 75 IU every 2 days to a maximum of 300 IU\u002Fday.\n2. GnRH antagonist is started at follicle size 12-14 m.\n3. Trigger is administered once the largest follicle gets \\>17 mm. Retrieval is scheduled 36 hrs later. IVF or ICSI fertilization. Luteal support from day past retrieval.\n4. Transfer of 1-2 embryos on day 3 or 5.\n5. Pregnancy test 12 days after ET.",[18],"Drug: use of combination of recombinant FSH and recombinant LH",{"label":20,"type":15,"description":21,"interventionNames":22},"higher dose FSH group (follitropin alpha (Gonal-F, Ovaleap) or follitropin delta (Rekovelle)","In this arm the hypo-responder patient will undergo stimulation using recombinant FSH but with a dose increase of 75 IU\u002Fday compared to the gonadotropin dose used in her previous treatment (e.g.: if 150 IU\u002Fd rec FSH was used then 225 IU\u002Fd will be used).\n\nTreatment steps:\n\n1. Stimulation using an additional 75 IU recombinant FSH per day compared to her previous treatment is started on day 2 or 3 of the menstrual cycle and is continued for 5 days. On day 6 the patient is seen for US and bloodwork. If indicated the dose can be increased by max. 75 IU every 2 days to a maximum of 300 IU\u002Fday.\n2. GnRH antagonist is started at follicle size 12-14 m.\n3. Trigger is administered once the largest follicle gets \\>17 mm. Retrieval is scheduled 36 hrs later. IVF or ICSI fertilization. Luteal support from day past retrieval.\n4. Transfer of 1-2 embryos on day 3 or 5.\n5. Pregnancy test 12 days after ET.",[23],"Drug: higher dose recFSH",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","use of combination of recombinant FSH and recombinant LH","in this arm the patients will use the combination of recFSH:recLH in the same dose as in her prior cycle",[14],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"higher dose recFSH","in this arm the patient will use an additional 75 IU\u002Fday recFSH compared to her previous drug dose",[20],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"unchanged dose","in this groups the patient will receive the same recFSH dose as in her prior cycle",[9],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Peter Kovacs, MD, PhD","CONTACT","+3612022802","peterkovacs1970@hotmail.com",[46,60,74,88],{"facility":5,"status":30,"city":47,"state":30,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Budapest","1125","Hungary","HU",{"type":52,"coordinates":53},"Point",[54,55],19.04045,47.49835,{"lat":55,"lon":54},[58],{"name":59,"role":42,"phone":43,"phoneExt":30,"email":44},"Peter Kovacs, MD",{"facility":61,"status":30,"city":62,"state":30,"zip":63,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Dunamenti REK Gyor IVF Center","Győr","9026",{"type":52,"coordinates":65},[66,67],17.63512,47.68333,{"lat":67,"lon":66},[70],{"name":71,"role":42,"phone":72,"phoneExt":30,"email":73},"Peter Boga, MD","+3696511210","bogahun@netscape.net",{"facility":75,"status":30,"city":76,"state":30,"zip":77,"country":49,"countryCode":50,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University of Szeged, Reproductive Medicine Institute","Szeged","6723",{"type":52,"coordinates":79},[80,81],20.14824,46.253,{"lat":81,"lon":80},[84],{"name":85,"role":42,"phone":86,"phoneExt":30,"email":87},"Janos Zadori, MD","+3662423623","jzadori@gmail.com",{"facility":89,"status":30,"city":90,"state":30,"zip":91,"country":49,"countryCode":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Dunamenti REK Tapolca IVF Center","Tapolca","8300",{"type":52,"coordinates":93},[94,95],17.44117,46.88152,{"lat":95,"lon":94},[98],{"name":99,"role":42,"phone":100,"phoneExt":30,"email":101},"Attila Torok, MD","+3687510365","attila@torok.info",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Peter Kovacs MD","medical director Dunamenti REK Istenhegyi IVF Center",[107,110,112],{"name":108,"class":109},"Dunamenti REK Gyor Clinic","UNKNOWN",{"name":111,"class":109},"Dunamenti REK Pannon Clinic",{"name":113,"class":6},"Szeged University","100602303","phase-4-optimal-stimulation-of-hypo-responders-undergoing-in-vitro-fertilization-ivf-100602303",false,"NCT07121751","Optimal Stimulation of Hypo-responders Undergoing in Vitro Fertilization (IVF)","Optimal Stimulation of Hypo-responders Undergoing IVF: a Prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\n* indication for IVF-ICSI\n* age 18-40 years\n* \\\u003C9 oocytes in a previous IVF cycle and having an AMH ≥1.2 ng\u002Fml and\u002For AFC ≥5 (POSEIDON 1,2)\n* The use of ≤225 IU FSH (either rFSH alone or the combination of rFSH+hMG) in the previous cycle\n* regular 24-35 day cycles\n* Intact uterine cavity\n* motile sperm from ejaculate or testicular biopsy\n\nExclusion Criteria:\n\n* not meeting the inclusion criteria\n* the use of rFSH:rLH (2:1 ratio) in the previous cycle\n* the use of clomiphene citrate or aromatase inhibitor in the previous cycle\n* \\>225 IU gonadotropin in the previous cycle\n* \\>3 failed previous treatments\n* patient with recurrent miscarriages\n* presence of a hydrosalpinx\n* positive HIV or hepatitis screening test\n* planned preimplantation genetic testing of the embryos\n* planned elective cryopreservation\n* lack of consent","FEMALE","18 Years","40 Years",{"count":125,"type":126},150,"ESTIMATED","INTERVENTIONAL",[129],"PHASE4","Stimulation is a key step of in vitro fertilization (IVF). Typically, injectable gonadotropins are used for stimulation, and their dose is individually determined to avoid hypo- as well as hyper-response. Despite the individualization some patients respond with a lower-than-expected number of oocytes. If the low response is unexpected based on the baseline parameters or if an unusually high dose of gonadotropins is needed to achieve a proper response we talk about \"hypo-response\". In such cases if the first treatment fails and a repeat attempt is planned typically even more gonadotropins, the combination of luteinizing hormone (LH) with follicle stimulating hormone (FSH) or the use of the more potent recombinant preparations are considered. The benefits of these approaches however have not been studied properly in hypo-responders. The studies have used various criteria to identify hypo-responders, have used various gonadotropin doses and have evaluated different outcome parameters. Live birth was only studied in one trial.\n\nIt is also known that in a different cycle the same patient is likely to have a slightly different response to the same type and dose of drugs. Therefore, the question arises whether a hypo-responder in one treatment is expected to have hypo-response again if the treatment is similarly carried out in a different cycle. Do we need to change\u002F increase the gonadotropin dose if based on age and ovarian reserve otherwise we would expect a normal response? Furthermore, if we consider a change should we increase the dose of FSH or should we combine it with LH?\n\nTherefore the aim of this randomized controlled trial is compare an unchanged medication regimen to increased dose of FSH vs the combination of FSH and LH in hypo-responder patients identified based on POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) criteria (Gr 1 and 2: retrieval of 9 or fewer oocytes in patients with an anti-Müllerian hormone (AMH) level ≥ 1.2 ng\u002Fml or antral follicle count (AFC) ≥ 5 and age \\\u003C35 years \\[Group (Gr) 1\\] or ≥35 years \\[Gr2\\]). Hypo-responder patients will be randomized to:\n\n1. Same gonadotropin dose as in previous treatment (recombinant(r) FSH) \\['control group'\\]\n2. The same dose as in the previous cycle but in the form of FSH + LH combination (rFSH:rLH 2:1 ratio) \\['additional LH group'\\]\n3. A dose increase of 75 international unit (IU) compared to the dose in the previous treatment. \\['higher dose FSH group'\\] The primary outcome parameter to study is live clinical pregnancy. In addition, baseline demographic, stimulation and further clinical outcomes (pregnancy rate, miscarriage rate, live birth rate) will be compared.",[132,133,134],"Hypo-responder","Infertility (IVF Patients)","OVARIAN STIMULATION",[136,137,138,139,140],"ovarian stimulation","in vitro fertilization","hypo-responder","gonadotropin","luteinizing hormone","NOT_YET_RECRUITING","2025-08-10",{"date":144,"type":145},"2025-08-13","ACTUAL",{"date":147,"type":126},"2025-09-01",{"date":149,"type":126},"2027-03-01",{"name":5,"class":6},4]