[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583394":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":41,"locations":47,"responsibleParty":118,"collaborators":122,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":30,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":30,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Dunamenti REK Istenhegyi IVF Center","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"No luteal support during modified natural cycle frozen embryo transfer","ACTIVE_COMPARATOR","In this arm the patient has her first ultrasound scheduled between days 9-12 of the cycle; the scan is repeated in 2-3 days if the follicle is not large enough or if the endometrium is thin (\\\u003C7 mm). Serum progesterone measurement at the time of the last ultrasound. If the progesterone level is \\\u003C1.5 ng\u002Fml and the follicle has reached at least 17 mm in diameters hCG (250 mcg recombinant hCG, Ovitrelle) is administered in the evening hours (7-10 PM) 5-6 days after the trigger injection, latest in the AM of the planned FET, serum progesterone is measured again. If the value is under 10 ng\u002Fml (31.8 nmol\u002Fl) vaginal luteal support is initiated and while we will proceed with the ET, the patient drops out of the RCT. If the progesterone is \\>31.8 nmol\u002Fl the patient receives no luteal support in this arm. 7 days after the hCG trigger she proceeds with the frozen embryo transfer.",[13],"Drug: no luteal support",{"label":15,"type":10,"description":16,"interventionNames":17},"Vaginal progesterone luteal support","In this arm the patient has her first ultrasound scheduled between days 9-12 of the cycle; the scan is repeated in 2-3 days if the follicle is not large enough or if the endometrium is thin (\\\u003C7 mm). Serum progesterone measurement at the time of the last ultrasound. If the progesterone level is \\\u003C1.5 ng\u002Fml and the follicle has reached at least 17 mm in diameters hCG (250 mcg recombinant hCG, Ovitrelle) is administered in the evening hours (7-10 PM) 5-6 days after the trigger injection, latest in the AM of the planned FET, serum progesterone is measured again. If the value is under 10 ng\u002Fml (31.8 nmol\u002Fl) vaginal luteal support is initiated and while we will proceed with the ET, the patient drops out of the RCT. If the progesterone is \\>31.8 nmol\u002Fl the patient in this arm still receives additional 2x200 mg vaginal progesterone luteal support (Utrogestan) starting on the day of embryo trasfer. 7 days after the hCG trigger she proceeds with the frozen embryo transfer.",[18],"Drug: Vaginal Progesterone",{"label":20,"type":10,"description":21,"interventionNames":22},"Vaginal progesterone plus small dose hCG luteal support","In this arm the patient has her first ultrasound scheduled between days 9-12 of the cycle; the scan is repeated in 2-3 days if the follicle is not large enough or if the endometrium is thin (\\\u003C7 mm). Serum progesterone measurement at the time of the last ultrasound. If the progesterone level is \\\u003C1.5 ng\u002Fml and the follicle has reached at least 17 mm in diameters hCG (250 mcg recombinant hCG, Ovitrelle) is administered in the evening hours.5-6 days after the trigger injection, serum progesterone is measured again. If the value is under 10 ng\u002Fml (31.8 nmol\u002Fl) vaginal luteal support is initiated and while we will proceed with the ET, the patient drops out of the RCT. If the progesterone is \\>31.8 nmol\u002Fl the patient in this arm receives 2x200 mg vaginal progesterone luteal support (Utrogestan) starting on the day of ET + 125 mcg rHCG s.c. on the day of ET and 62.5 mcg rHCG s.c. 4 days later. 7 days after the hCG trigger she proceeds with the frozen embryo transfer.",[23],"Drug: Progesterone plus HCG",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","no luteal support","In one arm of the study the patients receive no luteal support as part of their modified natural cycle frozen embryo transfer.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Vaginal Progesterone","In the 2nd arm the patient receives 2x200 mg vaginal progesterone as luteal support.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Progesterone plus HCG","In the 3rd arm the patients receive 2x200 mg vaginal progesteroen plus 125 mcg recombinant HCG s.c. on the day of embryo transfer and 62.5 mcg recombinant HCG s.c. 4 days later.",[20],[40],"Utrogestan",[42],{"name":43,"role":44,"phone":45,"phoneExt":30,"email":46},"Peter Kovacs MD medical director Dunamenti REK Istenhegyi IVF Center, MD, PhD","CONTACT","+3612022802","peterkovacs1970@hotmail.com",[48,60,75,90,104],{"facility":5,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":30},"RECRUITING","Budapest","1125","Hungary","HU",{"type":55,"coordinates":56},"Point",[57,58],19.04045,47.49835,{"lat":58,"lon":57},{"facility":61,"status":49,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Dunamenti REK Gyor IVF Center","Győr","Gyor","9026",{"type":55,"coordinates":66},[67,68],17.63512,47.68333,{"lat":68,"lon":67},[71],{"name":72,"role":44,"phone":73,"phoneExt":30,"email":74},"Peter Boga, MD","+3696511210","bogahun@netscape.net",{"facility":76,"status":49,"city":77,"state":78,"zip":79,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University of Pecs, Dept. OBGYN, Reproductive Center","Pécs","Pecs","7624",{"type":55,"coordinates":81},[82,83],18.22814,46.07617,{"lat":83,"lon":82},[86],{"name":87,"role":44,"phone":88,"phoneExt":30,"email":89},"Akos Varnagy, MD","+3672536370","varnagy.akos@pte.hu",{"facility":91,"status":49,"city":92,"state":92,"zip":93,"country":52,"countryCode":53,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of Szeged, Reproductive Medicine Institute","Szeged","6723",{"type":55,"coordinates":95},[96,97],20.14824,46.253,{"lat":97,"lon":96},[100],{"name":101,"role":44,"phone":102,"phoneExt":30,"email":103},"Janos Zadori, MD","+3662423623","jzadori@gmail.com",{"facility":105,"status":49,"city":106,"state":106,"zip":107,"country":52,"countryCode":53,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Dunamenti REK Tapolca IVF Center","Tapolca","8300",{"type":55,"coordinates":109},[110,111],17.44117,46.88152,{"lat":111,"lon":110},[114],{"name":115,"role":44,"phone":116,"phoneExt":30,"email":117},"Attila Torok, MD","+3687510365","attila@torok.info",{"type":119,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Peter Kovacs MD","medical director Dunamenti REK Istenhegyi IVF Center",[123,125,128,130],{"name":124,"class":6},"Medical University of Pecs",{"name":126,"class":127},"Dunamenti REK Gyor Clinic","UNKNOWN",{"name":129,"class":127},"Dunementi REK Pannon Clinic",{"name":131,"class":6},"Szeged University","100583394","phase-4-is-there-a-need-for-luteal-support-in-modified-natural-cycle-frozen-embryo-transfer-cycles-100583394",false,"NCT06875752","Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles","Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles: a Prospective, Multicenter, Randomized Trial","Inclusion Criteria:\n\n* Age 18-40 years at the time of vitrification\n* At least one good quality blastocyst frozen\n* Planned 1 blastocyst transfer\n* \\\u003C3 failed previous ETs\n* Cycle length between 21-35 days\n* Body mass index (BMI): 18-35 kg\u002Fm2\n* Intact uterine cavity based on hysteroscopy, hysteron-salpingogram, salina sonohysterogram\n* Consent to participate\n\nExclusion Criteria:\n\n* Age \\\u003C18 of over 40 at the time of vitrification\n* BMI: \\\u003C18 kg\u002Fm2 or \\>35 kg\u002Fm2\n* Planned transfer of more than 1 embryo\n* Irregular cycles (\\\u003C21 or \\>35 days)\n* Use of a protocol other than the modified natural cycle frozen embryo transfer\n* Lack of good morphology blastocysts\n* No evidence for spontaneous follicle development (no dominant (\\>17 mm) follicle by day 20 of cycle)\n* Patient with a history of recurrent miscarriages\n* Presence of a hydrosalpinx\n* Irregular uterine cavity\n* Positive test for HIV, hepatitis B or C\n* Lack of consent",true,"FEMALE","18 Years","40 Years",{"count":144,"type":145},180,"ESTIMATED","INTERVENTIONAL",[148],"PHASE4","Without progesterone there is no pregnancy. Following ovulation, the endocrine function of the follicle changes and progesterone replacing estradiol becomes its main secretory product. In the follicular phase the increasing amount of estradiol secreted by the growing follicle builds up the endometrium, while in the luteal phase progesterone, the main product of the corpus luteum, prepares the endometrium for implantation. This process is called decidualization. If implantation occurs, human chorionic gonadotropin (hCG) secreted by the trophopblasts maintains the function of the corpus luteum. This continued activity is required to be maintained up to week 7-9 of gestation when the hormone secreting activity is taken over by the placenta (luteo-placental shift) and the corpus luteum regresses.\n\nDuring in vitro fertilization (IVF) gonadotropins are used to induce multifollicular development and therefore following the oocyte retrieval (\"ovulation\") multiple corpora lutea are formed. At the same time, partly due to the supraphysiologic steroid levels reached during stimulation and partly to the removal of the granulosa cell mass during the retrieval, the activity of these corpora lutea remains insufficient and luteal support, primarily in the form of progesterone, is needed to achieve success.\n\nEmbryo cryopreservation has become available soon after the first successful IVF treatment. In some of the IVF treatments cryopreservation is electively planned, while in others surplus embryos are frozen. As a result of the currently available vitrification technology a close to 100% survival can be expected upon thawing.\n\nFrozen embryos can be transferred according to different protocols:\n\n1. True natural cycle FET (tNC-FET): in these cases, spontaneous follicle growth is followed by spontaneous ovulation and the timing of the embryo transfer (ET) is timed according to the spontaneous luteinizing hormone (LH) surge\n2. Modified natural cycle FET (mNC-FET): in these cases, follicle growth is spontaneous but ovulation is induced with hCG injection as soon as the follicle reaches maturity and the ET is timed to the trigger injection\n3. Stimulated cycle FET (sNC-FET): in these cases, follicle growth is induced with oral agents or gonadotropins and once the lead follicle reaches maturity hCG injection is given to induce ovulation and the ET is timed to the trigger injection\n4. Artificial, hormone replacement cycle (HRT-FET): in these cases, the ovaries are not active but estradiol is given to build up the endometrium and once proper thickness is reached progesterone is added to prepare to implantation According to the available evidence the different approaches are equally effective. The common theme in mNC, tNC and sNC FET cycles is that a corpus luteum is formed and its activity is not compromised by supraphysiologic steroid levels and the oocyte retrieval either. Despite this, in most clinics, similarly to the fresh IVF-ETs, luteal support is administered in FET cycles as well. The benefit of luteal support in NC-FET cycles is questionable, however. The available literature is inconclusive whether there is a need for luteal support in mNC-FET treatments? In order to answer this question, the investigators plan to perform a prospective, multicenter randomized pilot study.\n\nEligible participants will be randomized to one of the following groups:\n\n1. No luteal support\n2. 2x200 mg vaginal progesterone luteal support (Utrogestan) starting on the day of ET\n3. 2x200 mg vaginal progesterone luteal support (Utrogestan) starting on the day of ET + 125 mcg rHCG s.c. (1\u002F2 amp Ovitrelle) on the day of ET and 62.5 mcg rHCG s.c. (1\u002F4 amp Ovitrelle) 4 days later.\n\nBaseline demographic, FET treatment related, and clinical outcomes will be compared in the three different luteal phase management groups.",[151,152],"Luteal Support","Frozen Embryo Transfer (FET)",[154,155,156,157],"luteal support","frozen embryo transfer","progesterone","modified natural cycle","2025-07-22",{"date":160,"type":161},"2025-07-25","ACTUAL",{"date":163,"type":161},"2025-04-12",{"date":165,"type":145},"2026-12-01",{"name":5,"class":6},5]