Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-25 @ 6:46 AM
Study NCT ID:
NCT01809366
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2013-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-10', 'studyFirstSubmitDate': '2013-03-10', 'studyFirstSubmitQcDate': '2013-03-10', 'lastUpdatePostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implantation rate', 'timeFrame': '4 weeks after ET'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '4 weeks after ET'}, {'measure': 'ongoing pregnancy rate', 'timeFrame': '6 weeks after ET'}]}, 'conditionsModule': {'keywords': ['seminal plasma/uterine receptivity'], 'conditions': ['Effect on Implantation and Pregnancy Rates']}, 'descriptionModule': {'briefSummary': 'Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing oocyte pick up for IVF treatment\n\nExclusion Criteria:\n\n* endometriosis\n* low responders\n* uterine malformations'}, 'identificationModule': {'nctId': 'NCT01809366', 'briefTitle': 'Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'orgStudyIdInfo': {'id': '65/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'seminal plasma insemination', 'description': 'seminal plasma insemination', 'interventionNames': ['Procedure: seminal plasma insemination']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'culture medium insemination', 'description': 'culture medium insemination', 'interventionNames': ['Procedure: seminal plasma insemination']}], 'interventions': [{'name': 'seminal plasma insemination', 'type': 'PROCEDURE', 'armGroupLabels': ['culture medium insemination', 'seminal plasma insemination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zrifin', 'country': 'Israel', 'facility': 'Infertility and IVF Unit, Assaf harofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior', 'investigatorFullName': 'Assaf Harofeh MC', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}