Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06561451
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2024-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D000072660', 'term': 'Teratozoospermia'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020554', 'term': 'Sperm Injections, Intracytoplasmic'}], 'ancestors': [{'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-08-17', 'studyFirstSubmitQcDate': '2024-08-17', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth', 'timeFrame': '1 year after embryo transfer', 'description': 'Delivery ≥22 weeks of gestation with heartbeat and breath.'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '1 day after oocyte retrieval', 'description': 'Fertilized oocytes with two pronuclei per MII oocyte injected'}, {'measure': 'High-quality embryos on Day 3', 'timeFrame': '3 days after oocyte retrieval', 'description': 'Seven or eight blastomeres of equal-size and \\<20% fragmentation by volume'}, {'measure': 'hCG positivity', 'timeFrame': '14 days after embryo transfer', 'description': 'Serum hCG level ≥10mIU/mL'}, {'measure': 'Number and grading of embryos/blastocysts', 'timeFrame': '6 days after oocyte retrieval', 'description': 'Number and grading of embryos/blastocysts suitable for freezing and transfer'}, {'measure': 'Clinical pregnancy', 'timeFrame': '6 weeks of gestation', 'description': 'the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks.'}, {'measure': 'Ongoing pregnancy', 'timeFrame': '12 weeks of gestation', 'description': 'a viable pregnancy beyond 12 weeks of gestation'}, {'measure': 'Multiple pregnancy', 'timeFrame': '6 weeks of gestation', 'description': 'presence of more than one intrauterine sac at 6 weeks of gestation'}, {'measure': 'Cumulative live birth rate (within 6 months after randomization)', 'timeFrame': '1.5 years after the randomization', 'description': 'Any live birth arising from embryo transfer within 6 months after randomization'}, {'measure': 'Miscarriage rate', 'timeFrame': '22 weeks of pregnancy', 'description': 'A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy.'}, {'measure': 'Birth weights of the newborns', 'timeFrame': '1 year after embryo transfer', 'description': 'Birth weights of the newborns'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Infertility', 'Teratospermia']}, 'referencesModule': {'references': [{'pmid': '1351601', 'type': 'BACKGROUND', 'citation': 'Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.'}, {'pmid': '26346057', 'type': 'BACKGROUND', 'citation': 'Yeste M, Jones C, Amdani SN, Patel S, Coward K. Oocyte activation deficiency: a role for an oocyte contribution? Hum Reprod Update. 2016 Jan-Feb;22(1):23-47. doi: 10.1093/humupd/dmv040. Epub 2015 Sep 7.'}, {'pmid': '8408487', 'type': 'BACKGROUND', 'citation': 'Van Steirteghem AC, Nagy Z, Joris H, Liu J, Staessen C, Smitz J, Wisanto A, Devroey P. High fertilization and implantation rates after intracytoplasmic sperm injection. Hum Reprod. 1993 Jul;8(7):1061-6. doi: 10.1093/oxfordjournals.humrep.a138192.'}, {'pmid': '12524062', 'type': 'BACKGROUND', 'citation': 'De Vos A, Van De Velde H, Joris H, Verheyen G, Devroey P, Van Steirteghem A. Influence of individual sperm morphology on fertilization, embryo morphology, and pregnancy outcome of intracytoplasmic sperm injection. Fertil Steril. 2003 Jan;79(1):42-8. doi: 10.1016/s0015-0282(02)04571-5.'}, {'pmid': '22205614', 'type': 'BACKGROUND', 'citation': 'Lu YH, Gao HJ, Li BJ, Zheng YM, Ye YH, Qian YL, Xu CM, Huang HF, Jin F. Different sperm sources and parameters can influence intracytoplasmic sperm injection outcomes before embryo implantation. J Zhejiang Univ Sci B. 2012 Jan;13(1):1-10. doi: 10.1631/jzus.B1100216.'}, {'pmid': '23706334', 'type': 'BACKGROUND', 'citation': 'Greco E, Scarselli F, Fabozzi G, Colasante A, Zavaglia D, Alviggi E, Litwicka K, Varricchio MT, Minasi MG, Tesarik J. Sperm vacuoles negatively affect outcomes in intracytoplasmic morphologically selected sperm injection in terms of pregnancy, implantation, and live-birth rates. Fertil Steril. 2013 Aug;100(2):379-85. doi: 10.1016/j.fertnstert.2013.04.033. Epub 2013 May 23.'}, {'pmid': '24656559', 'type': 'BACKGROUND', 'citation': 'Vanden Meerschaut F, Nikiforaki D, Heindryckx B, De Sutter P. Assisted oocyte activation following ICSI fertilization failure. Reprod Biomed Online. 2014 May;28(5):560-71. doi: 10.1016/j.rbmo.2014.01.008. Epub 2014 Jan 31.'}, {'pmid': '22493027', 'type': 'BACKGROUND', 'citation': 'Vanden Meerschaut F, Nikiforaki D, De Gheselle S, Dullaerts V, Van den Abbeel E, Gerris J, Heindryckx B, De Sutter P. Assisted oocyte activation is not beneficial for all patients with a suspected oocyte-related activation deficiency. Hum Reprod. 2012 Jul;27(7):1977-84. doi: 10.1093/humrep/des097. Epub 2012 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the live birth rate between intracytoplasmic sperm injection (ICSI) and artificial oocyte activation (AOA) vs intracytoplasmic sperm injection alone in patients with teratospermia. The hypothesis is the live birth rate following ICSI and AOA is significantly higher than that by ICSI alone in patients with teratospermia. This is a randomized controlled trial. Participants will be randomly assigned into one of the two groups:\n\nICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.\n\nICSI alone group: a single sperm will be injected within 4 hours after the follicular aspiration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of women 20-37 years at the time of ovarian stimulation for ICSI\n2. At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.\n\nExclusion Criteria:\n\n1. Presence of hydrosalpinx which is not surgically treated\n2. Undergoing preimplantation genetic testing\n3. Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses)\n4. Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions)\n5. Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated'}, 'identificationModule': {'nctId': 'NCT06561451', 'briefTitle': 'Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia', 'organization': {'class': 'OTHER', 'fullName': 'ShangHai Ji Ai Genetics & IVF Institute'}, 'officialTitle': 'A Randomized Control Trial to Compare the Live Birth Rate Between Intracytoplasmic Sperm Injection and Artificial Oocyte Activation and Intracytoplasmic Sperm Injection Alone in Patients With Severe Teratospermia', 'orgStudyIdInfo': {'id': 'JIAI 2024-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICSI+AOA group', 'description': 'ICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.', 'interventionNames': ['Procedure: intracytoplasmic sperm injection and artificial oocyte activation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ICSI group', 'description': 'a single sperm will be injected within 4 hours after the follicular aspiration.', 'interventionNames': ['Procedure: intracytoplasmic sperm injection']}], 'interventions': [{'name': 'intracytoplasmic sperm injection and artificial oocyte activation', 'type': 'PROCEDURE', 'description': 'A single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.', 'armGroupLabels': ['ICSI+AOA group']}, {'name': 'intracytoplasmic sperm injection', 'type': 'PROCEDURE', 'description': 'A single sperm will be injected within 4 hours after the follicular aspiration.', 'armGroupLabels': ['ICSI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LI HE, MD', 'role': 'CONTACT', 'phone': '+8613817223099'}], 'facility': 'ShangHai JIAI Genetics &I VF Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'HE LI, MD', 'role': 'CONTACT', 'email': 'lihe198900@163.com', 'phone': '+8613817223099'}], 'overallOfficials': [{'name': 'Xiaoxi Sun, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai JiAi Genetics & IVF Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available from 3 months to 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Data from the trial will be shared according to the International Committee of Medical Journal Editors guidelines. Individual participant data that underlie the results after deidentification (text, tables, figures and appendices) and the study protocol will be shared. On request, data can be shared with parties presenting relevant aims for the use of data. Data will be available from 3 months to 5 years following article publication.', 'accessCriteria': 'On request, data can be shared with parties presenting relevant aims for the use of data. Please contact the researcher through email: lihe198900@163.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShangHai Ji Ai Genetics & IVF Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}