Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-21 @ 3:50 PM
Study NCT ID:
NCT02166567
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2014-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2014-06-14', 'studyFirstSubmitQcDate': '2014-06-17', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of embryos growing to the blastocyst stage', 'timeFrame': '5 days after intracytoplasmic sperm injection'}, {'measure': 'Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred', 'timeFrame': 'week 12 of gestation'}], 'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': 'Week 12 of gestation'}], 'secondaryOutcomes': [{'measure': 'Number of diploidic fertilized oocytes.', 'timeFrame': 'one day after intracytoplasmic sperm injection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracytoplasmic sperm injection', 'Male infertility', 'apoptosis', 'flow cytometry and sorting', 'DNA fragmentation'], 'conditions': ['Male Infertility']}, 'referencesModule': {'references': [{'pmid': '23809499', 'type': 'BACKGROUND', 'citation': 'Ribeiro SC, Sartorius G, Pletscher F, de Geyter M, Zhang H, de Geyter C. Isolation of spermatozoa with low levels of fragmented DNA with the use of flow cytometry and sorting. Fertil Steril. 2013 Sep;100(3):686-94. doi: 10.1016/j.fertnstert.2013.05.030. Epub 2013 Jun 27.'}, {'pmid': '31463874', 'type': 'DERIVED', 'citation': 'De Geyter C, Gobrecht-Keller U, Ahler A, Fischer M. Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection. J Assist Reprod Genet. 2019 Oct;36(10):2079-2086. doi: 10.1007/s10815-019-01571-1. Epub 2019 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertile couples needing treatment with ICSI\n* male infertility as defined by the WHO 2010 criteria\n* age of the treated women should be between 22 and 39 years of age.\n* normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l.\n* signed consent form.\n\nExclusion Criteria:\n\n* normal male infertility, as defined by the WHO 2010 criteria\n* age of the treated women below 22 years and above 39 years\n* reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration.\n* Not more than two preceding unsuccessfull treatments with ICSI\n* Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness.\n* Participation in another study.\n* lack of a signed consent form.'}, 'identificationModule': {'nctId': 'NCT02166567', 'acronym': 'Spermsorting', 'briefTitle': 'Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.', 'orgStudyIdInfo': {'id': 'EKBB178/12'}, 'secondaryIdInfos': [{'id': 'YOPRO', 'type': 'OTHER', 'domain': 'University of Basel'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YoPro and FACS', 'description': 'Spermatozoa to be used for ICSI will be stained with the YoPro Dye and then be sorted with FACS to select non-YoPro stained spermatozoa, known to have significantly less fragmented DNA.', 'interventionNames': ['Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Swim-up', 'description': 'Spermatozoa will be processed using the conventional swim-up me', 'interventionNames': ['Procedure: Swim-up']}], 'interventions': [{'name': 'Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS', 'type': 'PROCEDURE', 'otherNames': ['YoPro', 'FACS'], 'armGroupLabels': ['YoPro and FACS']}, {'name': 'Swim-up', 'type': 'PROCEDURE', 'description': 'Semen processing will be carried out with the conventional swim-up method.', 'armGroupLabels': ['Swim-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4031', 'city': 'Basel', 'state': 'Basel BS', 'country': 'Switzerland', 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christian De Geyter, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}