[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Conceivable Life Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100560739","automation-of-the-in-vitro-fertilization-laboratory-100560739",false,"NCT06581068","Automation of the In Vitro Fertilization Laboratory","Automation of the In Vitro Fertilization Laboratory: A Validation Study","Inclusion Criteria:\n\n* Informed consent signed by the patients before treatment.\n* Medical indication to perform assisted reproductive technology.\n* Body mass index between 20 and 29 kg\u002Fm2 (female participants only).\n* For women with indication of utilizing autologous eggs:\n\n  * Anti-Müllerian Hormone (AMH) value of at least 1.5 ng\u002FmL.\n  * 18 - 39 years of age.\n* For women utilizing donor eggs (egg donor age 18-28 years):\n\n  * 18 - 45 years of age.\n\nExclusion Criteria:\n\n* Patients diagnosed with recurrent pregnancy loss.\n* Inaccessible ovaries for puncture.\n* History of total or partial fertilization failure in a previous fertility treatment.\n* History of repeated implantation failure defined as three previous unsuccessful embryo transfers.\n* Uterine factors (e.g. fibroids, uterine surgeries, Müllerian malformations) at the discretion of the medical team and based on its impact on success and\u002For risk to the patient or the pregnancy may compromise treatment prognosis).\n* Untreated hydrosalpinx\n* Severe endometriosis III, IV, presence of endometriomas and\u002For history of endometrioma resection.\n* Polycystic ovarian syndrome.\n* Patients with any of the following severe male factor infertility:\n\n  * Sperm concentrations less than 5 million per mL\n  * Progressive motility less than 5%\n  * Others (e.g, globozoospermia and seminal infections) at the discretion of the medical team and based on its impact on success.\n  * Surgically retrieved sperm (TESE, MESA, PESA)\n* Pre-existing conditions compromising reproductive (e.g., thrombophilia, chronic degenerative and autoimmune diseases, uncontrolled hormonal disorders).\n* Any other case of abnormalities that could compromise success rates according to the criteria of clinical personnel in charge.\n* Inability to adhere to the medical protocols and\u002For schedules for personal reasons.\n* Intercurrent medical disorder",true,"ALL","18 Years","45 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","Enrolled patients will undergo an Assisted Reproductive technology (ART) treatment using intracytoplasmic sperm injection (ICSI, the direct injection of a single sperm cell into an oocyte) as the method of insemination. In this prospective cohort study, patients' sperm, eggs, and embryos will be processed using an automated system called AURA (Conceivable Life Sciences), which consists of five subsystems. Specifically, sperm samples will be prepared for fertilization using the subsystem C:SPERM. Cumulus-oocyte complexes (COCs) containing the oocytes will be isolated from follicular fluid using the subsystem C:EGG. One out of every four COCs will be removed from the AURA system at random and processed according to the local treatment clinic's standard operating procedure. All other COCs will continue automated procedures and will be denuded, fertilized, incubated, and vitrified using the AURA subsystems C:EGG. C:ICSI, C:CULTURE and C:VIT, respectively. All automated procedures will be conducted under the supervision of a laboratory manager, who can intervene, address any potential anomalies, and override any steps undertaken by the automated AURA system. The study aims to deliver a descriptive evaluation of the AURA system, including assessing the device's performance, defined by its level of automation, efficiency, and throughput. As a secondary objective, the study aims to characterize the clinical performance of each of AURA's subsystems and correlate this performance against pre-established benchmarks in a non-inferiority statistical analysis. Finally, the study seeks to collect technical data related to AURA's hardware and software operation.",[28,29],"Infertility","ART","RECRUITING","2026-03-16",{"date":33,"type":34},"2026-03-18","ACTUAL",{"date":36,"type":34},"2024-12-03",{"date":38,"type":22},"2027-02",{"name":40,"class":41},"Conceivable Life Sciences","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100608163","automation-of-oocyte-and-embryo-vitrification-100608163","NCT07197983","Automation of Oocyte and Embryo Vitrification","Automation of Oocyte and Embryo Vitrification: a Pilot Study","Inclusion Criteria:\n\n* BMI: Between 20-35 kg\u002Fm²\n* Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng\u002FmL\n\nExclusion Criteria:\n\n* Low ovarian reserve\n* Surgical sperm retrieval required","38 Years",{"count":51,"type":22},125,[25],"Purpose: This study aims to test whether a new automated system can freeze human eggs and embryos as effectively as the current manual method performed by laboratory staff.\n\nBackground: Currently, freezing eggs and embryos during fertility treatments (IVF\u002FICSI) is done entirely by hand by skilled embryologists. This manual process is time-consuming, requires extensive training, and outcomes can vary between different staff members. Automating this process could help standardize procedures, reduce costs, and potentially make fertility treatments more accessible to patients.\n\nWhat is Being Tested: The study will compare an automated freezing system (prototype designation PRESERVE-CR) against the standard manual freezing method. The key research question is: Can the automated system preserve eggs and embryos as successfully as experienced embryologists do by hand?\n\nHow It Works: Patients undergoing IVF\u002FICSI treatment at CARE Fertility Manchester who consent to participate will have their surplus eggs and embryos (those not suitable for their treatment) divided into two groups. Some will be frozen using the traditional manual method, and some using the new automated system. Both groups will then be thawed to measure survival rates. Tests do not encompass any reproductive outcomes or the creation of embryos specifically for this research.\n\nWhy This Matters: If successful, automated freezing could help reduce the workload on laboratory staff, standardize the freezing process across different clinics, potentially lower treatment costs, and make fertility treatments available to more people who need them. The study only uses oocytes and embryos which are unsuitable for patient treatment and that would otherwise be discarded, ensuring no impact on participants' actual fertility treatment.",[28],"2025-11-17",{"date":57,"type":34},"2025-11-20",{"date":59,"type":34},"2025-10-14",{"date":61,"type":22},"2026-06-30",{"name":40,"class":41},1,""]