Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-01 @ 10:52 AM
Study NCT ID:
NCT04523103
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2020-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Assisted Activation Following in Fertilization Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the normal fertilization rate', 'timeFrame': '12 months', 'description': 'Fertilization (2PN rate)'}], 'secondaryOutcomes': [{'measure': 'the good-quality embryo rate', 'timeFrame': '12 months', 'description': 'Embryo quality'}, {'measure': 'the blastocyst formation rate', 'timeFrame': '12 months', 'description': 'Embryo quality'}, {'measure': 'the good quality blastocyst rate', 'timeFrame': '12 months', 'description': 'Embryo quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fertilization failure, oocyte activation, calcium ionophore'], 'conditions': ['Fertilization']}, 'descriptionModule': {'briefSummary': 'Fertilization failure is a common problem in assisted reproductive Technology (ART). The main reason for fertilization failure of conventional IVF fertilization is sperm penetration failure, and the main reason of ICSI is insufficient oocyte activation. Artificial assisted activation may provide an effective technique to rescue fertilization failure. In this study, standard ICSI procedures were applied to save fertilization failure of unfertilized mature oocytes in IVF cycles. The unfertilized mature oocytes after ICSI were activated by calcium ion, or injected with calcium chloride/activated with mechanical stimulated and then transfer to calcium ion to improve fertilization. In this study, different artificial assisted activation methods were used to save the fertilization failure and assess its effective and subsequent embryo development potential.', 'detailedDescription': 'A variety of mechanical, electrical, and chemical methods has been used to trigger the calcium oscillations to activate oocytes. Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation, which can mimic calcium oscillations saving fertilization failure.\n\nControl group, a single spermatozoon was injected into the failed fertilization MII oocyte in conventional IVF cycle. What to do when ICSI fails? The investigators collected the unfertilized MII oocytes and divided them into 3 groups to perform different activation methods, including chemical calcium ionophore activation (experiment group 1), CaCl2 injected combined with calcium ionophore activation (experiment group 2), and mechanical stimulation combined with calcium ionophore activation (experiment group 3). Calcium ionophore A23187 (Sigma) was used for assisted activation. The final solution was 10 μmol/L. The oocytes were exposed to the calcium ionophore A23187 for 10 min at 37°C in 5% CO2. The oocytes were checked for pronucleus formation at 16-20 hours after activation. Fertilized oocytes were cultured in vitro for 3-5 days, the developmental potential of the activated embryos were observed.\n\nThis study want to explore the effective of different artificial assisted activation methods, to improve the fertilization outcome of unfertilized oocytes after ICSI or IVF.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8 ≤ Number of retrieved oocytes ≤ 20;\n* 18.5\\< Body Mass Index (BMI) \\<25;\n* The patients who suffered complete fertilization failure or low fertilization after performing standard ICSI/IVF cycle. Low fertilization was defined as less than 33% fertilization rate.\n\nExclusion Criteria:\n\n* Normal fertilization IVF/ICSI cycle.'}, 'identificationModule': {'nctId': 'NCT04523103', 'briefTitle': 'Artificial Assisted Activation Following in Fertilization Failure', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Clinical Study of Artificial Assisted Oocyte Activation Technique in IVF Fertilization Failure', 'orgStudyIdInfo': {'id': 'A0728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard ICSI procedure. The MII oocytes that failed fertilization in IVF cycles were injected with activating sperm.'}, {'type': 'EXPERIMENTAL', 'label': 'A1 assisted activation', 'description': 'The MII oocytes that failed fertilization in ICSI cycles were activated in calcium ionophore A23187 activation solution for two times.', 'interventionNames': ['Behavioral: Artificial Assisted Activation']}, {'type': 'EXPERIMENTAL', 'label': 'A2 assisted activation', 'description': 'Fertilization failure MII oocytes were collected in ICSI cycles. After CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 solution for two times.', 'interventionNames': ['Behavioral: Artificial Assisted Activation']}, {'type': 'EXPERIMENTAL', 'label': 'A3 assisted activation', 'description': 'Fertilization failure MII oocytes were collected in ICSI cycles. Mechanical activation was done for the MII oocytes, and then the oocytes were transferred into the calcium ionophore A23187 solution for two times.', 'interventionNames': ['Behavioral: Artificial Assisted Activation']}], 'interventions': [{'name': 'Artificial Assisted Activation', 'type': 'BEHAVIORAL', 'description': 'Artificial assisted activation represents an effective technique to rescue the fertilization failure.', 'armGroupLabels': ['A1 assisted activation', 'A2 assisted activation', 'A3 assisted activation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Wang Ming, Master', 'role': 'CONTACT', 'email': 'wangmingbio@snnu.edu.cn', 'phone': '8613259809290'}], 'overallOfficials': [{'name': 'Li Bo, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Reproductive Medicine Center, Tangdu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}