[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04149496":3,"trial-entities:NCT04149496":125,"trial-summary:NCT04149496":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":50,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":83,"locations":85,"central_contacts":104,"overall_officials":111,"references":114,"see_also_links":124},"NCT04149496","18-49","IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer","A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle","RECRUITING","2023-12-31","2019-10","2019-11-04","2019-05-10","Bruce Rose, MD","OTHER",false,"A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.","All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.",[19],"Polycystic Ovary Syndrome",[21,22,23,24,25,26],"IVM","in vitro maturation","polycystic ovarian syndrome","PCOS","Steiner-Tan needle","oocyte maturation","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},300,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"COMBINATION_PRODUCT","in vitro maturation of oocytes","Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization",[40],"All",[42,46],{"measure":43,"description":44,"timeFrame":45},"Percentage of treated patients having a clinical pregnancy","ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy","12 weeks post transfer",{"measure":47,"description":48,"timeFrame":49},"Percentage of treated patients having an ongoing pregnancy","pregnancy with cardiac activity (by history or observations) after 12 weeks","10 months post transfer",[51,55,59,63,67],{"measure":52,"description":53,"timeFrame":54},"Percentage of retrieved oocytes which matured per patient","proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval","2 days post retrieval",{"measure":56,"description":57,"timeFrame":58},"Percentage of retrieved oocytes which fertilized per patient","proportion of mature oocytes which display pronuclei","4 days post retrieval",{"measure":60,"description":61,"timeFrame":62},"Percentage of fertilized oocytes which divided","proportion of fertilized oocytes which become 2 or more cells","6 days post retrieval",{"measure":64,"description":65,"timeFrame":66},"Percentage of fertilized oocytes which became blastocysts per patient","proportion of fertilized oocytes which form a fluid filled cavity","8 days post retrieval",{"measure":68,"description":69,"timeFrame":70},"Percentage of patients who have a biochemical pregnancy after therir first transfer","proportion of patients with an hCG level greater than 5 measured post first transfer","28 days post transfer","FEMALE","18 Years","38 Years",{"inclusion":75,"exclusion":78,"raw_text":82},[76,77],"PCO pattern with \\> 25 antral follicles","AMH \\> 3.5",[79,80,81],"BMI \\> 35","body morphology making transvaginal retrieval difficult or impossible","complicating medical condition making pregnancy or IVF relatively contra-indicated","Inclusion Criteria:\n\n* PCO pattern with \\> 25 antral follicles\n* AMH \\> 3.5\n\nExclusion Criteria:\n\n* BMI \\> 35\n* body morphology making transvaginal retrieval difficult or impossible\n* complicating medical condition making pregnancy or IVF relatively contra-indicated",[84],"ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":101},"Brown Fertility","Jacksonville","Florida","32256","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Julius Varzoni, BS","CONTACT","904-260-0352","jvarzoni@brownfertility.com",{"name":99,"role":95,"phone":96,"email":100},"Meaghan German, RN","mgerman@brownfertility.com",{"lat":102,"lon":103},30.33218,-81.65565,[105,108],{"name":106,"role":95,"phone":96,"email":107},"Bruce I Rose, MD, PhD","brose@brownfertility.com",{"name":109,"role":95,"phone":96,"email":110},"Samuel Brown, MD","sbrown@brownfertility.com",[112],{"name":106,"affiliation":87,"role":113},"PRINCIPAL_INVESTIGATOR",[115,119,121],{"pmid":116,"type":117,"citation":118},"25374658","BACKGROUND","Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5.",{"type":117,"citation":120},"Rose BI: The case for more active management of endometrial development in IVM: Decreasing the miscarriage rate and increasing the clinical pregnancy rate. Journal of Reproductive Endocrinology and Infertility, 14: 1-6, 2016",{"pmid":122,"type":117,"citation":123},"23644950","Rose BI, Laky D. A comparison of the Cook single lumen immature ovum IVM needle to the Steiner-Tan pseudo double lumen flushing needle for oocyte retrieval for IVM. J Assist Reprod Genet. 2013 Jun;30(6):855-60. doi: 10.1007\u002Fs10815-013-0006-1. Epub 2013 May 5.",[],{"nct_id":4,"conditions":126,"biomarkers":127},[19],[128],"Muellerian-Inhibiting Factor",{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an interventional study with a planned enrollment of 300 participants. All participants will receive the IVM treatment.","completed","IVM with Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer for Polycystic Ovary Syndrome","This study is looking at a new way to help women with Polycystic Ovary Syndrome (PCOS) get pregnant using in vitro maturation (IVM). IVM involves collecting immature eggs and letting them mature in the lab before fertilization. This study uses oral medications like letrozole and very low doses of FSH (follicle-stimulating hormone) to prepare the ovaries, and a special needle (Steiner-Tan) for egg retrieval. After fertilization, embryos are frozen and transferred in a later cycle. We want to see how many patients become pregnant after 12 weeks and how many have an ongoing pregnancy after 10 months. You may be able to join if you are a woman between 18 and 38 years old, have a specific pattern of follicles in your ovaries (PCO pattern), and an AMH (Anti-Müllerian Hormone) level above 3.5. We cannot tell you if the study is currently enrolling.","Your pregnancy status will be checked at 12 weeks after embryo transfer and again at 10 months after embryo transfer.",143,"You will take oral contraceptives, then oral letrozole and low-dose FSH. You will have an HCG injection, followed by egg retrieval approximately 38 hours later. Embryos will be frozen and transferred in a separate cycle.","Not stated in the trial record.",[],"v2"]