[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652396":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":55,"studyPopulation":48,"armGroups":56,"interventions":67,"overallOfficials":73,"centralContacts":77,"locations":82,"responsibleParty":100,"collaborators":48,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":48,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":130,"whyStopped":48,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Vietnam Military Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Blastulation rate","The proportion of blastocysts formed among all mature (MII) oocytes subjected to intracytoplasmic sperm injection (ICSI), calculated as the total number of blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.","From ICSI to Day 6 of embryo culture",[14,18,22,26,29,33,36,40,44],{"measure":15,"description":16,"timeFrame":17},"Oocyte morphology abnormality rate","The proportion of retrieved oocytes that exhibit one or more morphological abnormalities, calculated as the number of retrieved oocytes with morphological abnormalities divided by the total number of oocytes retrieved, multiplied by 100.","At the time of oocyte denudation, prior to ICSI",{"measure":19,"description":20,"timeFrame":21},"Fertilization rate","The proportion of mature (MII) oocytes subjected to ICSI that are normally fertilized, defined by the presence of two pronuclei (2PN), calculated as the number of normally fertilized oocytes divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.","Approximately 16-18 hours after ICSI",{"measure":23,"description":24,"timeFrame":25},"Cleavage embryo formation rate","The proportion of MII oocytes subjected to ICSI that develop into cleavage-stage embryos, calculated as the number of cleavage-stage embryos divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.","Approximately 68-72 hours after ICSI",{"measure":27,"description":28,"timeFrame":25},"Good-quality cleavage-stage embryo rate","The proportion of MII oocytes subjected to ICSI that result in good-quality cleavage-stage embryos, according to the morphological criteria prespecified in the study protocol, calculated as the number of good-quality cleavage-stage embryos divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.",{"measure":30,"description":31,"timeFrame":32},"Good-quality blastocyst rate","The proportion of MII oocytes subjected to ICSI that result in good-quality blastocysts, according to the morphological criteria prespecified in the study protocol, calculated as the number of good-quality blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.","From Day 5 to Day 6 after ICSI",{"measure":34,"description":35,"timeFrame":32},"Usable blastocyst rate","The proportion of MII oocytes subjected to ICSI that result in usable blastocysts, according to the criteria prespecified in the study protocol, calculated as the number of usable blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.",{"measure":37,"description":38,"timeFrame":39},"Biochemical pregnancy rate","The proportion of first frozen embryo transfer cycles with a positive serum beta-human chorionic gonadotropin (β-hCG) test, defined according to the prespecified threshold in the study protocol, among all first frozen embryo transfer cycles.","Approximately 14 days after frozen embryo transfer",{"measure":41,"description":42,"timeFrame":43},"Clinical pregnancy rate","The proportion of first frozen embryo transfer cycles resulting in a clinical pregnancy, defined by the presence of at least one gestational sac on ultrasound, calculated as the number of clinical pregnancies divided by the number of first frozen embryo transfer cycles, multiplied by 100.","Approximately 5-7 weeks after frozen embryo transfer",{"measure":45,"description":46,"timeFrame":47},"Ongoing pregnancy rate","The proportion of first frozen embryo transfer cycles resulting in an ongoing pregnancy, according to the definition prespecified in the study protocol, calculated as the number of ongoing pregnancies divided by the number of first frozen embryo transfer cycles, multiplied by 100.","Approximately 12 weeks after frozen embryo transfer",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE","This study is designed to evaluate whether the starting dose of follicle-stimulating hormone (FSH) affects oocyte and embryo outcomes in women with a good prognosis undergoing in vitro fertilization (IVF) using a progestin-primed ovarian stimulation (PPOS) protocol.\n\nThe optimal gonadotropin dose for women with a good prognosis remains uncertain. Although higher FSH doses may increase ovarian stimulation intensity, greater gonadotropin exposure may not necessarily improve oocyte or embryo outcomes. Conversely, a lower starting dose may provide adequate ovarian stimulation while reducing medication exposure. Therefore, this study will compare two starting FSH doses, 225 IU and 300 IU, in women with a good reproductive prognosis.\n\nEligible participants will be randomly assigned to receive either 225 IU or 300 IU of FSH as the starting dose during PPOS. The study will assess whether the starting FSH dose is associated with differences in oocyte characteristics, fertilization, embryo development, and blastocyst formation. The primary outcome is blastocyst formation rate. Secondary outcomes will include oocyte morphology, fertilization rate, cleavage-stage embryo development and quality, and blastocyst quality and usability.\n\nParticipants will also be followed through the first frozen embryo transfer cycle using embryos generated during the study cycle. Outcomes of the first frozen embryo transfer cycle will be assessed as prespecified secondary outcomes.\n\nThe results of this study may provide evidence to guide the selection of an appropriate starting FSH dose for women with a good prognosis undergoing IVF with PPOS.",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"FSH 225 IU","EXPERIMENTAL","Participants assigned to this arm will receive a starting dose of 225 IU follicle-stimulating hormone (FSH) during progestin-primed ovarian stimulation (PPOS) for in vitro fertilization (IVF).",[62],"Drug: Follitropin Alfa (Follitrope)",{"label":64,"type":59,"description":65,"interventionNames":66},"FSH 300 IU","Participants assigned to this arm will receive a starting dose of 300 IU follicle-stimulating hormone (FSH) during progestin-primed ovarian stimulation (PPOS) for in vitro fertilization (IVF).",[62],[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":48},"DRUG","Follitropin Alfa (Follitrope)","Follicle-stimulating hormone (FSH) is administered by subcutaneous injection as the gonadotropin for ovarian stimulation in a progestin-primed ovarian stimulation (PPOS) protocol. Participants are randomized to receive either 225 IU or 300 IU of FSH daily according to their assigned study arm, and the assigned dose is maintained unchanged throughout the ovarian stimulation period.",[58,64],[74],{"name":75,"affiliation":5,"role":76},"Truc Nhu Thanh Vo, PhD Student","PRINCIPAL_INVESTIGATOR",[78],{"name":75,"role":79,"phone":80,"phoneExt":48,"email":81},"CONTACT","+84 0764681310","vonhuthanhtruc.art@gmail.com",[83],{"facility":84,"status":48,"city":85,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"An Sinh Hospital","Ho Chi Minh City","722210","Vietnam","VN",{"type":90,"coordinates":91},"Point",[92,93],106.62965,10.82302,{"lat":93,"lon":92},[96,97,99],{"name":75,"role":79,"phone":80,"phoneExt":48,"email":81},{"name":48,"role":79,"phone":48,"phoneExt":48,"email":98},"trucvnt@ansinh.com.vn",{"name":75,"role":76,"phone":48,"phoneExt":48,"email":48},{"type":76,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Vo Nhu Thanh Truc","Head of IVF laboratory","100652396","225-iu-versus-300-iu-starting-fsh-dose-in-ppos-for-good-prognosis-women-100652396",false,"NCT07772375","225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women","A Randomized Controlled Trial Comparing 225 IU Versus 300 IU Starting Doses of Follicle-Stimulating Hormone in Progestin-Primed Ovarian Stimulation for Women With Good Prognosis","FSH-PPOS","Inclusion Criteria:\n\n* Female patient or oocyte donor aged \\\u003C35 years.\n* Body mass index (BMI) between 18 and 25 kg\u002Fm².\n* Normal ovarian reserve, defined by:\n\n  * Antral follicle count (AFC) ≥8 on ultrasound; and\n  * AMH level between 1.5 and 4.5 ng\u002FmL.\n* First IVF treatment cycle.\n* Controlled ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol with recombinant FSH and dydrogesterone.\n* Indication for in vitro fertilization using intracytoplasmic sperm injection (ICSI).\n* Indication for extended embryo culture to the blastocyst stage.\n* Willingness to participate in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n* Polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria, currently referred to as polyendocrine metabolic ovarian syndrome (PMOS).\n* Structural abnormalities of the ovaries.\n* Ovarian endometriosis.\n* Medical or gynecological conditions that may affect ovarian response to controlled ovarian stimulation.\n* Indication for luteinizing hormone (LH) supplementation during controlled ovarian stimulation.\n* Poor sperm quality, cryptozoospermia, surgically retrieved sperm (PESA, TESE, or microTESE), cryopreserved sperm, or donor sperm.\n* Indication for artificial oocyte activation (AOA) or rescue ICSI (R-ICSI).","FEMALE","18 Years","34 Years",{"count":115,"type":116},380,"ESTIMATED","INTERVENTIONAL",[119],"NA","This randomized controlled trial will compare two starting doses of follicle-stimulating hormone (FSH), 225 IU and 300 IU, during progestin-primed ovarian stimulation (PPOS) in women undergoing in vitro fertilization (IVF) who have a good reproductive prognosis. Participants will be randomly assigned to receive either 225 IU or 300 IU of FSH at the start of ovarian stimulation. The study will evaluate whether the starting FSH dose affects oocyte and embryo outcomes, with blastocyst formation as the primary outcome. Other outcomes will include oocyte morphology, fertilization, embryo development, and embryo quality. The findings may help determine an appropriate starting FSH dose for women with a good prognosis undergoing IVF using the PPOS protocol.",[122,123],"Infertility (IVF Patients)","Infertility Assisted Reproductive Technology",[125,126,127,128,129],"Progestin-primed ovarian stimulation","PPOS","FSH dose","Embryo quality","blastulation","NOT_YET_RECRUITING","2026-08-17",{"date":133,"type":134},"2026-08-19","ACTUAL",{"date":136,"type":116},"2026-08-15",{"date":138,"type":116},"2029-08-31",{"name":5,"class":6},1]