[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606439":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":66,"collaborators":24,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":24,"maxAge":24,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Shady Grove Fertility Reproductive Science Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracytoplasmic Sperm Injection (ICSI)","EXPERIMENTAL","In this arm, a portion of each participant's mature oocytes will be inseminated using intracytoplasmic sperm injection (ICSI). A single frozen-thawed donor sperm cell will be injected directly into each oocyte using micromanipulation techniques. The oocyte assignment to ICSI will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under standard laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes.",[13],"Procedure: Intracytoplasmic Sperm Injection (ICSI)",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional Insemination (IVF)","In this arm, a portion of each participant's oocytes will be inseminated using the conventional in vitro fertilization (IVF) method. Frozen-thawed donor sperm with normal post-thaw parameters will be co-incubated with oocytes in culture media for fertilization. The oocyte assignment to this method will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under the same laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes.",[18],"Procedure: Conventional Insemination (IVF)",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Mature oocytes are injected with a single frozen-thawed donor sperm cell using micromanipulation under a microscope. This fertilization method is performed shortly after oocyte retrieval. Sperm used are pre-screened and standardized for post-thaw motility and morphology. ICSI is conducted in accordance with standard embryology lab protocols. The oocyte allocation to ICSI is randomized within each participant's cycle.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Oocytes are inseminated by co-incubation with frozen-thawed donor sperm in a culture dish for 16-18 hours. Sperm are washed and prepared according to lab protocol to ensure motility and concentration suitability. This method does not involve direct sperm injection. Oocytes are randomly assigned to this method within each participant's retrieved cohort.",[15],[29],{"name":30,"affiliation":31,"role":32},"Kate Devine, MD","Shady Grove Fertility","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Allison Eubanks, MD","CONTACT","301-400-2432","Allison.Eubanks@sgfertility.com",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Tasha Newsome","3015451289","Tasha.Newsome@sgfertility.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Shady Grove Fertility Rockville","RECRUITING","Rockville","Maryland","20850","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-77.15276,39.084,{"lat":56,"lon":55},[59,61,63],{"name":40,"role":36,"phone":60,"phoneExt":24,"email":42},"301-545-1289",{"name":35,"role":62,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":64,"role":65,"phone":24,"phoneExt":24,"email":24},"Phillip Romanski, MD","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Kate Devine","Medical Director and Chief Research Officer","100606439","sister-sibling-oocyte-insemination-with-frozen-sperm-from-third-party-donors-evaluation-of-reproductive-techniques-100606439",false,"NCT07175571","SISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques","Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm","SISTER","Inclusion Criteria:\n\n* Female patients undergoing IVF with frozen donor sperm at Shady Grove Fertility Center\n* Normal ovarian reserve (AMH \\> 1 ng\u002FmL, AFC \\> 10)\n* Absence of male factor infertility\n* Post-wash parameters: \\>50% motility, \\>5mil concentration\n* \\> 4 oocytes retrieved at time of transvaginal oocyte retrieval\n\nExclusion Criteria:\n\n* Donor Sperm with significant male factor infertility (e.g., abnormal sperm concentration, motility, or morphology)\n* Any medical condition contraindicating ART","FEMALE",{"count":79,"type":80},95,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this clinical trial is to learn whether two different methods of helping eggs and sperm join-intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF)-lead to better embryo development when using frozen donor sperm in people who do not have male fertility problems. The main questions it aims to answer are:\n\nDoes one method create more usable embryos (blastocysts) than the other?\n\nIs there a difference in how often fertilization does not happen at all?\n\nDo either of the methods lead to better embryo quality or early pregnancy?\n\nParticipants will:\n\nHave their eggs divided into two groups. One group will be fertilized using ICSI (where a sperm is injected directly into an egg), and the other using conventional IVF (where eggs are mixed with sperm in a dish).\n\nThe fertilization method for each egg will be randomly assigned, with a random process also used to determine the assignment of any extra egg when an odd number is collected.\n\nContinue regular fertility treatment while the study team compares the results of each fertilization method.\n\nThis study includes people with non-male factor infertility and uses frozen donor sperm. It hopes to learn whether ICSI, which is often used even when it may not be needed, truly helps improve outcomes compared to conventional IVF in these cases.",[86,87,88],"Infertility, Female","Reproductive Techniques, Assisted","Fertilization in Vitro",[9,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"Conventional IVF","Frozen Donor Sperm","Sibling-Oocyte Design","Non-Male Factor Infertility","Blastulation Rate","Total Fertilization Failure (TFF)","Fertilization Outcomes","Embryo Quality","Clinical Pregnancy Rate","Assisted Reproductive Technology (ART)","Embryo Development","In Vitro Fertilization","Oocyte Randomization","Female Infertility","Cryopreserved Sperm","Randomized Controlled Trial (RCT)","Reproductive Medicine","Fertility Treatment","2025-09-09",{"date":110,"type":111},"2025-09-16","ACTUAL",{"date":113,"type":80},"2025-09-15",{"date":115,"type":80},"2026-05-01",{"name":5,"class":6},1]