[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606162":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Mỹ Đức Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IVM-Fresh (No gonadotropin + Fresh embryo transfer)","EXPERIMENTAL","Endometrial preparation will be conducted using an artificial cycle protocol initiated on day 2-4 of the menstrual cycle (either spontaneous or induced). CAPA-IVM treatment will subsequently be performed, followed by oocyte fertilization and fresh embryo transfer.",[13],"Procedure: IVM-Fresh (No gonadotropin + Fresh embryo transfer)",{"label":15,"type":16,"description":17,"interventionNames":18},"IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)","ACTIVE_COMPARATOR","Ovarian stimulation will be performed using a GnRH-antagonist protocol starting on any day of the menstrual cycle. Embryos obtained from ICSI will be cryopreserved for later transfer.",[19],"Procedure: IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Patients randomized to this arm will receive estradiol valerate 8 mg\u002Fday. IVM will be performed after ≥10 days of estrogen and ET ≥8 mm. From the day of ICSI, they will continue estradiol and start vaginal progesterone 800 mg\u002Fday + dydrogesterone (20mg\u002Fday). A fresh embryo transfer will subsequently be performed.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients randomized into this group will receive FSH at a dose of 150 IU\u002Fday. Oocyte retrieval will be performed once the criteria for triggering are fulfilled, followed by embryo cryopreservation and frozen embryo transfer in the subsequent cycle. Endometrial preparation for frozen embryo transfer will be conducted using an exogenous steroids regimen. Patients will receive estradiol 8 mg\u002Fday starting from cycle days 2-3 for 10 days. When the endometrial thickness reaches ≥8 mm, luteal phase support will be initiated with vaginal progesterone 800 mg\u002Fday plus dydrogesterone 20 mg\u002Fday.",[15],[30],{"name":31,"affiliation":32,"role":33},"Lan N Vuong, MD, PhD","University of Medicine and Pharmacy at Ho Chi Minh City","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Vu NA Ho, MD, PhD","CONTACT","+84935843336","bsvu.hna@myduchospital.vn",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"IVFMD - My Duc Hospital","RECRUITING","Ho Chi Minh City","Vietnam","VN",{"type":48,"coordinates":49},"Point",[50,51],106.62965,10.82302,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":25,"email":57},"Tuong M Ho, MD","+84 90 3633377","tuongho.ivfmd@gmail.com",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100606162","ivm---fresh-et-the-saigon-protocol-versus-ivf---fet-in-pcos-women-100606162",false,"NCT07171970","IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women","The Effectiveness and Safety of In Vitro Maturation With Fresh Embryo Transfer (The SAIGON Protocol) Versus In Vitro Fertilization With Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome","SAIGON-PTC","Inclusion Criteria:\n\n* Women aged 18 - 42 years old.\n* Diagnosed with PCOS, followed Rotterdam 2003 criteria (Group TREP consensus workshop, 2004)\n* Had fewer than three previous failed frozen embryo transfer (FET) cycles\n* Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts.\n* Agreeing to participate in the study\n\nExclusion Criteria:\n\n* Having allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)\n* Cycles with preimplantation genetic testing indication\n* Oocyte donation cycles\n* Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate\u002F bicornuate\u002F arcuate uterus, large leiomyoma ≥5 cm in diameter; adenomyosis, endometrial polyp, hydrosalpinx).","FEMALE","18 Years","42 Years",{"count":72,"type":73},600,"ESTIMATED","INTERVENTIONAL",[76],"NA","Assisted Reproductive Technologies (ART) aim to increase success rates while minimizing patient risks. For women with high AFC or PCOS, conventional IVF carries a high risk of OHSS (Ho et al., 2019). A modern IVF strategy to prevent this uses a GnRH agonist trigger, requiring a \"freeze-all\" and subsequent FET (Wong et al., 2017). This reduces OHSS risk but can increase time to pregnancy (Vuong et al., 2021) and treatment burden.\n\nIVM is a patient-friendly alternative that eliminates OHSS risk by avoiding high-dose gonadotropins. A 2020 trial by Vuong et al. compared CAPA-IVM-FET to conventional IVF-FET in women with high AFC. IVM yielded a comparable live birth rate (35.2%) versus IVF (43.2%), with a 0% OHSS rate in IVM compared to 0.7% in IVF (Vuong et al., 2020).\n\nThe optimal transfer method (fresh or frozen) in IVM cycles is debated. A 2021 pilot RCT by Vuong et al. found a freeze-only strategy after CAPA-IVM led to a significantly higher live birth rate (60%) than a fresh transfer (20%) (Vuong et al., 2021), but increased time to pregnancy (194 vs. 150 days) (Vuong et al., 2021). A refined CAPA-IVM protocol, which uses no gonadotropins, allowed for fresh embryo transfer in the same cycle, resulting in a numerically higher ongoing pregnancy rate (43.3% vs. 33.3%) than FET (Vuong et al., 2025).\n\nThis raises an important question: how does a simplified IVM strategy with fresh transfer compare to the established \"safety-net\" IVF strategy with FET? These two approaches represent opposing clinical philosophies. No large-scale study has yet compared them in women with PCOS. Therefore, this study is designed to compare the SAIGON protocol (gonadotropin-free CAPA-IVM with fresh ET) against a standard GnRH-antagonist IVF protocol with agonist trigger and subsequent FET.",[79,80,81],"Polycystic Ovary Syndrome (PCOS)","In Vitro Maturation of Oocytes","Fresh Embryo Transfer",[83,84,85,86,87],"in vitro maturation","The SAIGON protocol","fresh embryo transfer","GnRH-Antagonist","frozen embryo transfer","2025-09-30",{"date":90,"type":91},"2025-10-01","ACTUAL",{"date":93,"type":91},"2025-09-22",{"date":95,"type":73},"2028-01-15",{"name":5,"class":6},1]