Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-01 @ 7:35 AM
Study NCT ID:
NCT00731159
Status:
UNKNOWN
Last Update Posted:
2008-08-08
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013075', 'term': 'Sperm Capacitation'}, {'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D005306', 'term': 'Fertilization'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-07', 'studyFirstSubmitDate': '2008-08-07', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertilization rate of human oocytes in thr "routine" IVF Laboratory work', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sperm Capacitation']}, 'descriptionModule': {'briefSummary': 'Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments', 'detailedDescription': 'Capacitation is a physiologic process in which the sperm acquire the potential to fertilize oocytes. Capacitation can be measured, but the available technics are expensive, inaccurate and complex. A new method to evaluate sperm capacitation was developed in Bar Ilan University, Israel. We intend to measure the capacitation of semen that is used for fertilizing human oocytes in patients treated at the IVF unit at Assaf Harofeh Medical Center.By this, to evaluate the potential of the new method to predict human oocyte fertilization.If the method will be found valuable, it will enable to develop new drugs/methods that may improve sperm capacitation and by this to improve oocyte fertilization leading to more embryos, pregnancies and deliveries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring IVF within the "routine" work of an IVF Unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring IVF within the "routine" work of an IVF Unit\n* normo-responding woman\n* non ICSI cycles\n\nExclusion Criteria:\n\n* Patients undergoing ICSI only cycle\n* Low responders-less than 8 oocytes\n* Male patients with low semen volume'}, 'identificationModule': {'nctId': 'NCT00731159', 'briefTitle': 'Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment', 'orgStudyIdInfo': {'id': '54/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Sperm capacitation:\n\nSperm capacitation is measured in a sample of the same ejaculated sperm unit given for fertilizing human oocytes in an IVF treatment cycle', 'interventionNames': ['Biological: sperm capacitation', 'Other: biologic', 'Other: sperm capacitation']}], 'interventions': [{'name': 'sperm capacitation', 'type': 'BIOLOGICAL', 'description': 'sperm capacitation measured at Bar Ilan University', 'armGroupLabels': ['A']}, {'name': 'biologic', 'type': 'OTHER', 'otherNames': ['sperm capacitation'], 'description': 'sperm synthesis of G-actine to F-actine', 'armGroupLabels': ['A']}, {'name': 'sperm capacitation', 'type': 'OTHER', 'otherNames': ['sperm synthesis of G-actine to F-actine'], 'description': 'sperm synthesis of G-actine to F-actine', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Beer Yaacov', 'state': 'Zerifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'arieh raziel, prof', 'role': 'CONTACT', 'email': 'araziel@asaf.health.gov.il', 'phone': '97289779005'}, {'name': 'raphael ron-el, prof', 'role': 'CONTACT', 'email': 'rronel@asaf.health.gov.il', 'phone': '97289779005'}, {'name': 'arieh raziel, prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'raphael ron-el, prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assaf Harofeh MC'}], 'centralContacts': [{'name': 'arieh raziel, prof', 'role': 'CONTACT', 'email': 'araziel@asaf.health.gov.il', 'phone': '97289779005'}, {'name': 'raphael ron-el, prof', 'role': 'CONTACT', 'email': 'rronel@asaf.health.gov.il', 'phone': '97289779005'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Prof A Raziel', 'oldOrganization': 'Assaf Harofeh MC'}}}}