Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-28 @ 6:12 PM
Study NCT ID:
NCT06951061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006379', 'term': 'Helping Behavior'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical pregnancy rate', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks', 'description': 'Positive urinary pregnancy test after fresh or frozen embryo transfer per embryo transfer.'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks.', 'description': 'Presence of gestational sac at ultrasound control after fresh or frozen embryo transfer per embryo transfer.'}, {'measure': 'Live birth rate', 'timeFrame': 'From enrollment to the end of treatment at delivery.', 'description': 'Live birth per embryo transfer after fresh and frozen embryo transfer.'}], 'secondaryOutcomes': [{'measure': 'Number of frozen embryos', 'timeFrame': 'From enrollment to the end of treatment at 5 days.', 'description': 'Number of embryos at blastocyst stage that are frozen.'}, {'measure': 'Miscarriage rate', 'timeFrame': 'From enrollment to the end of treatment before 22 weeks.', 'description': 'Miscarriage per clinical pregnancy after fresh and frozen embryo transfer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perinatal outcomes', 'IVF', 'ICSI', 'surgically retrieved sperm'], 'conditions': ['Reproductive Technology, Assisted', 'IVF Outcomes', 'ICSI']}, 'descriptionModule': {'briefSummary': 'This research project explores how the source of sperm affects outcomes in assisted reproductive technologies (ART), focusing on children conceived through intracytoplasmic sperm injection (ICSI) with surgically retrieved sperm (SRS). Outcomes will be compared to those from ICSI with ejaculated sperm and conventional IVF. Using national registry data from all IVF and ICSI treatments in Sweden between 2007 and 2023 (Q-IVF), the study applies artificial intelligence (AI) and machine learning (ML) to identify factors influencing success rates. The aim is to improve prediction models and support more personalized fertility treatments. Special emphasis is placed on understanding the potential risks and long-term health outcomes for children conceived using SRS, which may be associated with higher rates of genetic abnormalities. The results may help optimize care strategies for infertile couples.', 'detailedDescription': 'This research project aims to improve our understanding of how different sources of sperm affect outcomes in assisted reproductive technologies (ART). The focus is on children conceived through intracytoplasmic sperm injection (ICSI) using surgically retrieved sperm (SRS), compared to ICSI with ejaculated sperm and conventional in vitro fertilization (IVF).\n\nThe study has three main goals:\n\n1. To compare reproductive outcomes following ICSI with SRS, ICSI with ejaculated sperm, and conventional IVF.\n2. To investigate whether artificial intelligence (AI) and machine learning (ML) algorithms can predict cumulative reproductive outcomes, including results from both fresh and frozen embryo transfer cycles.\n3. To evaluate how AI/ML-based models perform in comparison to traditional statistical methods in terms of accuracy and predictive value.\n\nMethod: National Population-Based Registry Study: This includes all IVF and ICSI treatments performed in Sweden from January 1, 2007, to December 31, 2023, using data from the Swedish National Quality Registry for Assisted Reproduction (Q-IVF). AI will be used to analyze large datasets, detect patterns, and help identify key factors-such as sperm source, number of retrieved oocytes, and patient characteristics-that may influence treatment success. This approach could lead to personalized treatment plans and better predictions of successful pregnancy outcomes.\n\nSpecial attention is given to outcomes in children born after ICSI with surgically retrieved sperm, as these sperm may be less mature and carry a higher risk of genetic abnormalities. The findings are expected to provide valuable insights into the reproductive and long-term health outcomes of these treatments, ultimately helping to improve care and treatment strategies for infertile couples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this population-based project, data from the National Quality Registry Q-IVF will be employed to identify a birth cohort comprising all IVF treatments performed in Sweden between January 1, 2007, and December 31, 2023. This time frame aligns with the establishment in 2007 of the National Quality Registry for Assisted Reproduction (Q-IVF). This cohort will be followed until December 31, 2023, resulting in a 16-year period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All IVF treatments performed in Sweden during the study period.\n* IVF treatments will be identified from the National register Q-IVF.\n\nExclusion Criteria:\n\n* Children born from multiple pregnancies\n* Children conceived through oocyte and sperm donation'}, 'identificationModule': {'nctId': 'NCT06951061', 'acronym': 'SRS-ICSI outc', 'briefTitle': 'Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Reproductive Outcomes in Children Born Through Assisted Reproduction (ART): Focus on Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.', 'orgStudyIdInfo': {'id': '2025-00935-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVF with ejaculated sperm', 'description': 'This group have gone through IVF with ejaculated sperm. Both fresh and frozen cycles are included.', 'interventionNames': ['Procedure: IVF/ICSI']}, {'label': 'ICSI with ejaculated sperm', 'description': 'This group have gone through ICSI with ejaculated sperm. Both fresh and frozen cycles are included.', 'interventionNames': ['Procedure: IVF/ICSI']}, {'label': 'ICSI with surgically retrieved sperm', 'description': 'This group have gone through ICSI with surgically retrieved sperm. Both fresh and frozen cycles are included.', 'interventionNames': ['Procedure: IVF/ICSI']}], 'interventions': [{'name': 'IVF/ICSI', 'type': 'PROCEDURE', 'description': 'In vitro fertilization with or without ICSI with ejaculated and surgically retrieved sperm.', 'armGroupLabels': ['ICSI with ejaculated sperm', 'ICSI with surgically retrieved sperm', 'IVF with ejaculated sperm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Clinical Science, Intervention and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Panagiotis Tsiartas, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared because the data will be retrieved from Q-IVF in anonymized form, ensuring that no individual can be identified. As such, there is no access to raw, identifiable data, and sharing is restricted to protect patient confidentiality and comply with data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Panagiotis Tsiartas', 'investigatorAffiliation': 'Karolinska Institutet'}}}}