[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"embryo-culture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:embryo-culture":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100596827","a-multicenter-prospective-randomized-controlled-clinical-trial-comparing-constant-5-versus-sequential-5-2-oxygen-concentration-embryo-culture-protocols-in-assisted-reproductive-technology-100596827",false,"NCT07050537","A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology","A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology: Evaluating Term Live Birth and Offspring Health Outcomes","Inclusion Criteria:\n\n1. Female: age ≥20 and ≤40 years, male: age ≥20 and ≤50 years;\n2. Proposed 1st or 2nd cycle of IVF or ICSI fertilization;\n3. ≥ 4 transferable embryos at oocyte stage.\n\nExclusion Criteria:\n\n1. Diagnosis of abnormal uterine cavity morphology (confirmed by 3D ultrasound or hysteroscopy), including uterine malformations (mediastinal uterus, unicornuate uterus, bicornuate uterus), submucosal uterine fibroids, or uterine adhesions;\n2. Patients who are proposed to undergo IVM;\n3. Patients who are proposed to undergo PGD\u002F PGS;\n4. Patients with untreated severe hydrosalpinx (confirmed by ultrasound or HSG);\n5. Patients with a history of recurrent miscarriage (2 or more previous pregnancy losses, excluding biochemical pregnancies);\n6. Patients who plan to freeze whole embryos and are unable to complete a single embryo transfer within six months;\n7. Patients with contraindications to assisted reproductive technology and pregnancy, or suffering from diseases that have a definite effect on pregnancy: including uncontrolled hypertension, heart disease with definite symptoms, uncontrolled diabetes, undefined diagnosis of liver or kidney disease or liver or kidney insufficiency, severe anemia, history of previous venous thrombosis, pulmonary embolism or cerebrovascular events, history of malignant tumors, suspected malignant tumors, and undiagnosed abnormal uterine bleeding.","FEMALE","20 Years","40 Years",{"count":20,"type":21},980,"ESTIMATED","INTERVENTIONAL",[24],"NA","To evaluate whether there were significant differences in the effects of constant (5%) versus sequential (5%-2%) oxygen concentration protocols in embryo culture on term live birth rates.\n\nThis study will be conducted in five centers including the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical Universit. 980 women who wish to undergo blastocyst transplantation will be included in the study.\n\nThe study data will be analyzed statistically.",[27,28,29],"Fertility Issues","Blastocyst IVF","Embryo Culture",[28,31],"Fertility","RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-01","ACTUAL",{"date":38,"type":36},"2025-03-01",{"date":40,"type":21},"2027-08-31",{"name":42,"class":43},"The First Affiliated Hospital with Nanjing Medical University","OTHER",6,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100633099","evaluation-of-an-undisturbed-embryo-culture-system-for-embryo-development-in-ivficsi-cycles-100633099","NCT07522281","Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF\u002FICSI Cycles","A Prospective, Multicenter, Randomized Controlled Clinical Trial of an Undisturbed Embryo Culture System for Improving the In Vitro Developmental Potential of Embryos","Embryos UECS","Inclusion Criteria:\n\n* Patients entering an ART cycle at the reproductive medicine center after study initiation and meeting the indications for IVF or ICSI;\n* No more than two previous IVF\u002FICSI embryo transfer cycles;\n* Agreement to culture all fertilized embryos to the blastocyst stage (Day 5\u002FDay 6);\n* AMH ≥1.2 ng\u002FmL and AFC ≥7;\n* Fewer than 20 oocytes retrieved and serum estradiol level on the day of hCG administration \\\u003C5000 pg\u002FmL.\n\nExclusion Criteria:\n\n* History of low fertilization rate in previous cycles (fertilization rate \\\u003C25%);\n* Oocyte donation or sperm donation cycles;\n* Either partner has a known chromosomal abnormality on karyotype analysis, or the couple plans to undergo preimplantation genetic testing (PGT);\n* Conditions that may affect oocyte quality, including premature ovarian insufficiency, endometriosis, ovarian endometrioma, or a history of two or more pelvic surgeries;\n* Requirement for surgical sperm retrieval, including microsurgical sperm retrieval or testicular sperm extraction;\n* Significant untreated uterine factors that may impair embryo implantation, including: submucosal uterine fibroids; two or more intramural fibroids, with the largest diameter ≥3 cm and significant compression of the uterine cavity causing cavity distortion; untreated moderate to severe intrauterine adhesions; one or more endometrial polyps with a maximum diameter ≥1.0 cm, or two or more space-occupying endometrial polyps within the uterine cavity; untreated moderate to severe hydrosalpinx (diameter ≥3 cm);\n* History of fertilization or oocyte maturation disorders, including fertilization - failure in a previous ICSI cycle or previous oocyte maturation disorder.",true,"45 Years",{"count":56,"type":21},478,[24],"This is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether a fully undisturbed closed embryo culture system can improve the developmental potential of embryos cultured in vitro and provide high-quality evidence for its clinical application. Participants must meet all of the following criteria to be eligible for this study: 1）Patients meeting the indications for IVF or ICSI; 2)No more than two previous IVF\u002FICSI embryo transfer cycles; 3) Willingness to culture all fertilized embryos to the blastocyst stage (Day 5\u002F6); 4) AMH ≥1.2 ng\u002FmL and AFC ≥7; 5) Fewer than 20 oocytes retrieved and serum estradiol level on the day of hCG administration \\\u003C5000 pg\u002FmL. Exclusion Criteria (Participants meeting any of the following criteria will be excluded): 1）History of low fertilization rate in previous cycles (fertilization rate \\\u003C25%); 2）Oocyte donation or sperm donation cycles; 3）Either partner has a known chromosomal abnormality on karyotype analysis, or the couple plans to undergo preimplantation genetic testing (PGT); 4）Conditions that may affect oocyte quality, including premature ovarian insufficiency, endometriosis, ovarian endometrioma, or a history of two or more pelvic surgeries; 5）Requirement for surgical sperm retrieval, including microsurgical sperm retrieval or testicular sperm extraction; 6）Significant untreated uterine factors that may impair embryo implantation, including: submucosal uterine fibroids; two or more intramural fibroids, with the largest diameter ≥3 cm and significant compression of the uterine cavity causing cavity distortion; untreated moderate to severe intrauterine adhesions; one or more endometrial polyps with a maximum diameter ≥1.0 cm, or two or more space-occupying endometrial polyps within the uterine cavity; untreated moderate to severe hydrosalpinx (diameter ≥3 cm); 7）History of fertilization or oocyte maturation disorders, including fertilization failure in a previous ICSI cycle or previous oocyte maturation disorder. After ovarian stimulation, all cumulus-oocyte complexes (COCs) from each patient will be randomly allocated in a 1:1 ratio to the control group or the experimental group.In the control group, oocytes will be fertilized using Vitrolife fertilization medium and cultured in a conventional sequential culture system consisting of a benchtop incubator and sequential culture media. In the experimental group, oocytes will be fertilized using Gems FEM fertilization medium and cultured in an undisturbed system consisting of a Geri incubator and Gems one-step culture medium. After culture of all embryos to the blastocyst stage, a single best-quality blastocyst (better than 4BC) will be selected for transfer according to the Gardner morphological grading system, provided that patient interests are not compromised. The primary outcome is clinical pregnancy rate, defined as the proportion of clinical pregnancy cycles among all embryo transfer cycles. Clinical pregnancy will be assessed 4-7 weeks after embryo transfer by ultrasound detection of an intrauterine gestational sac or pathological confirmation of miscarriage tissue. Secondary outcomes include fertilization rate, normal fertilization rate after ICSI, cleavage rate, Day 3 good-quality embryo rate, Day 3 usable embryo rate, good-quality blastocyst formation rate, Day 5\u002F6 usable blastocyst rate, blastocyst formation rate, implantation rate, biochemical pregnancy rate, early miscarriage rate, ongoing pregnancy rate, live birth rate.\n\nBased on an average clinical pregnancy rate of 50%, and assuming a non-inferiority margin of 12% (Δ = -0.12), with α = 0.05, β = 0.20, 80% power, and 1:1 allocation, at least 430 cycles will be required. After allowing for a 10% dropout rate, a total of 478 cycles (239 per group) will be enrolled.\n\nParticipant recruitment is planned from November 1, 2025, to December 30, 2027, across the following 12 study centers: Center for Reproductive Medicine, The Sixth Affiliated Hospital, Sun Yat-sen University (leading center); Center for Reproductive Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Reproductive Center, Northwest Women's and Children's Hospital; Shenzhen Zhongshan Obstetrics and Gynecology Hospital; Assisted Reproduction Center, Jiangxi Maternal and Child Health Hospital; Center for Reproductive Medicine, West China Second University Hospital, Sichuan University; Center for Reproductive Medicine, General Hospital of Ningxia Medical University; Reproductive Center, Affiliated Hospital of Jining Medical University; Center for Reproductive Medicine, Nanjing Maternal and Child Health Care Hospital; Reproductive Center, Chenzhou First People's Hospital; Center for Reproductive Medicine, Changde First People's Hospital; and Center for Reproductive Medicine, The First Affiliated Hospital of Hainan Medical University.",[29,60,61],"Embryo Culture Media","Embryo Quality","NOT_YET_RECRUITING","2026-04-12",{"date":65,"type":36},"2026-04-15",{"date":65,"type":21},{"date":68,"type":21},"2027-12-30",{"name":70,"class":43},"Sun Yat-sen University",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100581484","evaluating-the-influence-of-3d-culture-dish-design-on-preimplantation-genetic-development-in-sibling-oocytes-a-randomized-trial-100581484","NCT06850909","Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial","Inclusion Criteria:\n\n* Female patients aged 35 years or younger\n* A minimum of 15 mature oocytes available for ICSI\n* Classified as a good prognosis patient\n\nExclusion Criteria:\n\n* Cases with severe DNA fragmentation\n* Patients undergoing FNA or TESE procedures\n* Severe male factor infertility\n* History of low or failed fertilization in previous cycles\n* Any contraindications to gonadotropin stimulation\n* Presence of leukocytospermia","ALL","35 Years",{"count":80,"type":21},200,[24],"Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial",[29],[85,86],"3D culture dish","embryo culture","2025-02-26",{"date":89,"type":36},"2025-02-28",{"date":38,"type":21},{"date":92,"type":21},"2026-03-30",{"name":94,"class":43},"Ganin Fertility Center",1]