[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556361":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":26,"responsibleParty":39,"collaborators":18,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":18,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":18,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria y Biomédica de Alicante","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MACS","EXPERIMENTAL","Oocytes corresponding to this group were inseminated by spermatozoa selected after the use of MACS.",[13],"Device: Magnetic Activated Cell Sorting",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Oocytes corresponding to this group were inseminated with spermatozoa obtained after density gradient centrifugation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Magnetic Activated Cell Sorting","The MACS® ART Annexin V System has been designed for the in vitro elimination of apoptotic human spermatozoa in fresh, cryopreserved or otherwise manipulated semen samples. Samples processed by this technique can be subsequently used in any assisted reproduction procedure.\n\nAnnexin V recognizes externalized phosphatidylserine (ePS) on the plasma membrane of apoptotic spermatozoa. Depletion of the altered sperm begins with magnetic tagging of the sperm. The system selectively retains unwanted sperm by utilizing the natural ability of annexin V to recognize the ePS on the plasma membrane of the altered sperm, because annexin V is conjugated to metal microspheres. The labeled cells pass through a separation column in a fixed magnetic field. Unwanted (altered) spermatozoa are selectively retained in the separation column. Unlabeled spermatozoa pass through the column where they are collected for later use.",[9],[9],[27],{"facility":28,"status":18,"city":29,"state":18,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":18},"ISABIAL","Alicante","03010","Spain","ES",{"type":34,"coordinates":35},"Point",[36,37],-0.48149,38.34517,{"lat":37,"lon":36},{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Borja Tejero Llinares","Biologist","100556361","the-aim-of-this-study-is-to-determine-the-incidence-of-alterations-in-fluorescent-in-situ-hybridisation-fish-of-spermatozoa-and-to-evaluate-the-efficacy-of-the-use-of-annexin-columns-macs-in-patients-with-altered-fish-undergoing-in-vitro-fertilisation-techniques-100556361",false,"NCT06524102","The Aim of This Study is to Determine the Incidence of Alterations in Fluorescent In Situ Hybridisation (FISH) of Spermatozoa and to Evaluate the Efficacy of the Use of Annexin Columns (MACS®) in Patients With Altered FISH Undergoing In Vitro Fertilisation Techniques","Evaluation of the Efficacy of Annexin Columns (MACS) in Patients With Altered Sperm FISH Undergoing Assisted Reproductive Techniques","Inclusion Criteria:\n\n* Women between 18 and 40 years of age. Men between 18 and 55 years of age.\n* Couples without any common, previous and healthy children.\n* Couples with indication of IVF-ICSI cycle with Preimplantation Genetic Test for Aneuploidy (PGT-A).\n* Men with altered sperm FISH results.\n\nExclusion Criteria:\n\n* Prior voluntary sterilization.\n* Existence of documented medical contraindication for infertility treatment.\n* Existence of documented medical contraindication to pregnancy.\n* Existence of a documented medical situation that seriously interferes with the development of the offspring.\n* Impossibility to comply with the treatment for health-related reasons or other family or social environment-related reasons.\n* Existence of a documented situation referring to any other circumstance that may seriously interfere with the development of the offspring submitted for consideration to a health care ethics committee or similar body.\n* One or both partners with positive serology for HIV, HBV and VDRL.\n* One or both partners with partner with altered karyotype.","ALL","18 Years","55 Years",{"count":54,"type":55},10,"ACTUAL","INTERVENTIONAL",[58],"NA","250 petitions for FISH of spermatozoa were requested, determining the total and particular incidence in each of the indications collected. The effect of annexin columns was evaluated in 10 couples with altered FISH. In each of the couples, oocytes were pseudo-randomised to the control group and MACS®. All couples received experimental treatment. Mixed logistic regression model were adjusted to evaluate the effect of MACS® on the response variables studied.",[61],"Infertility, Male",[63,64,65,9,66],"In Vitro Fertilization","sperm FISH","annexin columns","Preimplantation Genetic Testing for aneuploidies","COMPLETED","2024-07-25",{"date":70,"type":55},"2024-07-29",{"date":72,"type":55},"2018-01-01",{"date":74,"type":55},"2022-03-31",{"name":5,"class":6},1]