[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"in-vitro-maturation-of-oocytes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:in-vitro-maturation-of-oocytes":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100582038","phase-3-fertilo-in-vitro-research-study-and-trial-100582038",false,"NCT06858111","Fertilo In Vitro Research Study and Trial","Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)","FIRST","Inclusion Criteria:\n\n1. Written informed consent.\n2. Premenopausal, Age 18-35.\n3. Body mass index (BMI) 21-40.\n4. Candidate for IVF according to the ASRM definition (infertile for ≥12 months, require the use of donor sperm, or the inability to achieve a successful pregnancy based on a patient's medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors).\n5. No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.\n6. Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.\n7. Anti-mullerian hormone (AMH) ≥ 3 ng\u002FmL within 6 months of Screening\u002FVisit 1 or assessed at the screening visit.\n8. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening\u002FVisit 1 or assessed at the screening visit.\n9. Having adequate visualization of both ovaries, without evidence of significant abnormality\u002Fpathology or major cyst documented by transvaginal ultrasound within 3 months of screening or assessed during screening period.\n10. No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma.\n11. Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation.\n12. Have a male partner with semen analysis within the past 12 months prior to randomization considered adequate to proceed with intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If this criterion is not met, the subject can only be entered if donor sperm will be used.\n\nExclusion Criteria:\n\n1. History of recurrent pregnancy loss (defined as \\>2 clinical pregnancies without live birth).\n2. Baseline prolactin levels greater than 30 ng\u002Fml\n3. Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.\n4. Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.\n5. Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.\n6. Use of donated oocytes, embryos or blastocysts for this treatment cycle while participating in the study or use of oocytes, embryos, or blastocysts from a previous treatment cycle.\n7. Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.",true,"FEMALE","18 Years","35 Years",{"count":22,"type":23},500,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation.\n\nResearchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm.\n\n* Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours.\n* Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.",[29],"In Vitro Maturation of Oocytes",[31,32,33,34,35,36,37],"IVF","IVM","In Vitro Fertilization","Fertilo","Gameto","infertility","fertility","RECRUITING","2026-06-03",{"date":41,"type":42},"2026-06-04","ACTUAL",{"date":44,"type":42},"2025-04-17",{"date":46,"type":23},"2028-01",{"name":48,"class":49},"Gameto, Inc.","INDUSTRY",13,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100606162","ivm---fresh-et-the-saigon-protocol-versus-ivf---fet-in-pcos-women-100606162","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).","42 Years",{"count":61,"type":23},600,[63],"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.",[66,29,67],"Polycystic Ovary Syndrome (PCOS)","Fresh Embryo Transfer",[69,70,71,72,73],"in vitro maturation","The SAIGON protocol","fresh embryo transfer","GnRH-Antagonist","frozen embryo transfer","2025-09-30",{"date":76,"type":42},"2025-10-01",{"date":78,"type":42},"2025-09-22",{"date":80,"type":23},"2028-01-15",{"name":82,"class":83},"Mỹ Đức Hospital","OTHER",1]