Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05693220
Status:
RECRUITING
Last Update Posted:
2023-04-03
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sperm Preparation Prior to Intrauterine Insemination Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D000858', 'term': 'Anovulation'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002499', 'term': 'Centrifugation, Density Gradient'}], 'ancestors': [{'id': 'D014461', 'term': 'Ultracentrifugation'}, {'id': 'D002498', 'term': 'Centrifugation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative clinical pregnancy rate', 'timeFrame': '3 treatment cycles, an average of 5 months', 'description': 'The clinical pregnancy rate by treatment group over the course of IUI treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intrauterine Insemination', 'Insemination', 'Fertility', 'Infertility'], 'conditions': ['Infertility', 'Infertility Secondary', 'Infertility Unexplained', 'Anovulation', 'Fertility Disorders', 'Reproductive Issues']}, 'referencesModule': {'references': [{'pmid': '31543253', 'type': 'BACKGROUND', 'citation': 'Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.'}, {'pmid': '30007319', 'type': 'BACKGROUND', 'citation': 'Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.', 'detailedDescription': 'Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing intrauterine insemination\n* Patient assigned female at birth with age \\<41\n\nExclusion Criteria:\n\n* Any significant disease or psychiatric disorder that would interfere with the consenting process\n* Prior intrauterine insemination\n* Use of frozen donor sperm\n* Non-English speaker'}, 'identificationModule': {'nctId': 'NCT05693220', 'acronym': 'PIoUS', 'briefTitle': 'Sperm Preparation Prior to Intrauterine Insemination Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)', 'orgStudyIdInfo': {'id': '22-36913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Density gradient centrifugation', 'description': 'Patients will undergo sperm preparation by density gradient centrifugation', 'interventionNames': ['Other: Density gradient centrifugation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zymot sperm separation device', 'description': 'Patients will undergo sperm preparation by the Zymot sperm separation device', 'interventionNames': ['Device: Zymot Multi sperm separation device']}], 'interventions': [{'name': 'Zymot Multi sperm separation device', 'type': 'DEVICE', 'description': 'Sperm preparation with Zymot Multi sperm preparation device', 'armGroupLabels': ['Zymot sperm separation device']}, {'name': 'Density gradient centrifugation', 'type': 'OTHER', 'description': 'Sperm preparation with density gradient centrifugation', 'armGroupLabels': ['Density gradient centrifugation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alisha T Tolani, MD', 'role': 'CONTACT', 'email': 'alisha.tolani@ucsf.edu', 'phone': '628-286-7307'}, {'name': 'Elena Hoskin', 'role': 'CONTACT', 'email': 'elena.hoskin@ucsf.edu'}, {'name': 'Alisha T Tolani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mitchell Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSF Center for Reproductive Health', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Alisha T Tolani, MD', 'role': 'CONTACT', 'email': 'alisha.tolani@ucsf.edu', 'phone': '6282867307'}, {'name': 'Elena Hoskin', 'role': 'CONTACT', 'email': 'elena.hoskin@ucsf.edu'}], 'overallOfficials': [{'name': 'Mitchell Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}