Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT03240302
Status:
UNKNOWN
Last Update Posted:
2017-08-07
First Post:
2017-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of fertilization rate', 'timeFrame': 'Three years', 'description': 'Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and PICSI methods will be compared.'}, {'measure': 'Comparison of embryo quality', 'timeFrame': 'Three years', 'description': 'Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and PICSI methods will be compared.'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': 'Three years', 'description': 'Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and PICSI methods will be compared.'}, {'measure': 'Pregnancy rate', 'timeFrame': 'Three years', 'description': 'Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and PICSI methods will be compared.'}, {'measure': 'Miscarriage rate', 'timeFrame': 'Three years', 'description': 'Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and PICSI methods will be compared.'}, {'measure': 'Live birth rate', 'timeFrame': 'Three years', 'description': 'Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and PICSI methods will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 18-60\n* Females aged 18-35\n* Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle\n* Males with normozoospermia with at least 2 unexplained failed IVF cycles\n* Females with normal FSH and normal AMH values\n* Females who have retrieved in previous cycles at least 6 oocytes\n\nExclusion Criteria:\n\n* Couples who have been exposed to heavy smoking, drugs and chronic diseases\n* Males who have undergone testicular surgery (TESE) or defined as severe OTA\n* Females with egg factor infertility'}, 'identificationModule': {'nctId': 'NCT03240302', 'briefTitle': 'A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)', 'orgStudyIdInfo': {'id': 'HYMC-0069-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ICSI Procedure', 'description': 'The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte using a standard ICSI petri dish.', 'interventionNames': ['Device: ICSI petri dish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PICSI Procedure', 'description': 'The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom.', 'interventionNames': ['Device: PICSI petri dish']}], 'interventions': [{'name': 'ICSI petri dish', 'type': 'DEVICE', 'description': 'Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.', 'armGroupLabels': ['ICSI Procedure']}, {'name': 'PICSI petri dish', 'type': 'DEVICE', 'description': 'Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.', 'armGroupLabels': ['PICSI Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Medeia Michaeli, PhD', 'role': 'CONTACT', 'email': 'medeia.michaeli@gmail.com', 'phone': '972-50-6246885'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Medeia Michaeli, PhD', 'role': 'CONTACT', 'email': 'medeia.michaeli@gmail.com', 'phone': '972-50-6246885'}], 'overallOfficials': [{'name': 'Einat Shalom Paz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}, {'name': 'Medeia Michaeli, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}