[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575001":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Mỹ Đức Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Super-GDF9 supplementation during CAPA-IVM","EXPERIMENTAL","Group 1: donated COCs will be cultured in the CAPA step and the IVM step, with the addition of Super-GDF9 during CAPA-IVM.",[13],"Other: Super-GDF9 supplementation during CAPA-IVM",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional CAPA-IVM","ACTIVE_COMPARATOR","Group 2: The subject's remaining COCs will be cultured in the CAPA step and the IVM step without the addition of Super-GDF9 during CAPA-IVM.",[19],"Other: Conventional CAPA-IVM",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Group 1: donated COCs will be exposed to Super-GDF9 at 50 ng\u002Fml in both the CAPACITATION and MATURATION culture steps.",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":30,"role":31},"Lan N Vuong","University of Medicine and Pharmacy at Ho Chi Minh City","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Kha T Huynh","CONTACT","+84946699470","kha.ht@myduchospital.vn",[39],{"facility":40,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"My Duc Hospital","RECRUITING","Ho Chi Minh City","Vietnam","VN",{"type":46,"coordinates":47},"Point",[48,49],106.62965,10.82302,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":54,"phoneExt":24,"email":55},"Tuong M Ho, MSc, MD","+84 90 3633377","tuongho.ivfmd@gmail.com",{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[59],{"name":60,"class":6},"Vrije Universiteit Brussel","100575001","effect-of-super-gdf9-on-capa-ivm-of-cocs-from-small-antral-follicles-100575001",false,"NCT06766604","Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles","Exploratory In-vitro Study Evaluating the Addition of Super-GDF9 During Capacitation-in-vitro Maturation (CAPA-IVM) of Donated Human Cumulus-oocyte Complexes (COCs) Derived From Small Antral Follicles","sGDF-9","Inclusion Criteria:\n\n1. Women between the ages of 18 and 38 years (both inclusive)\n2. BMI ≤ 32 kg\u002Fm2\n3. PCOS women according to the Rotterdam criteria (2003)\n4. Indicating CAPA-IVM treatment.\n5. Serum AMH ≥ 4 ng\u002FmL (28.57 pmol\u002FL) at screening and having at least 24 antral follicles in two ovaries by transvaginal ultrasound at the time of CAPA-IVM indication\n6. Willing to donate COCs for research purposes\n7. Agreeing for frozen embryo\n8. Signed informed consent before any study-related procedures\n\nExclusion Criteria:\n\n1. Known endometrioma or grade 3-4 endometriosis according to ASRM classification\n2. Uterine abnormalities\n3. Couples with severe male factor (sperm concentration \\\u003C5 million\u002Fml, motility \\\u003C 10%), surgical sperm retrieval.\n4. Previous history of unexplained immature oocytes after IVF treatment\n5. Cycles using donor oocytes","FEMALE","18 Years","38 Years",{"count":73,"type":74},9,"ESTIMATED","INTERVENTIONAL",[77],"NA","CAPA-IVM (In Vitro Maturation) technology is an assisted reproductive method offering significant benefits in terms of safety and treatment costs, particularly for high-risk patients. These include individuals with ovarian hyperstimulation syndrome (OHSS), venous thrombosis, ovarian torsion, or polycystic ovary syndrome (PCOS). However, while the live birth rate in the CAPA-IVM group (35.2%) is comparable to conventional IVF (43.2%), the number of good-quality embryos and cumulative clinical pregnancy rates remain lower. Improving the CAPA-IVM culture process, particularly through the addition of growth factors found in follicular fluid, has shown promise in enhancing oocyte quality.\n\nGrowth differentiation factor 9 (GDF9) and Bone morphogenetic protein 15 (BMP15) play critical roles in follicular development, with their heterodimer structure demonstrating the most positive effects on cumulus-oocyte complexes (COCs). Recent studies have identified a potent variant, super GDF9, which is \\>1000 times more effective than GDF9 and surpasses cumulin, a heterodimeric growth factor. Super GDF9 enhances cumulus cell expansion and oocyte developmental competence, closely mimicking in vivo maturation.\n\nThis study investigates the impact of supplementing super GDF9 during CAPA-IVM culture, aiming to improve outcomes of cumulus-oocyte complexes (COCs) from small follicles and ultimately enhance treatment success.",[80],"In Vitro Fertilization",[82,83,84,85,86],"CAPA-IVM","super-GDF9","Culture","OSFs","PCOS","2025-07-09",{"date":89,"type":90},"2025-07-10","ACTUAL",{"date":92,"type":90},"2025-01-10",{"date":94,"type":74},"2026-04-30",{"name":5,"class":6},1]