Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-09 @ 1:48 AM
Study NCT ID:
NCT02358733
Status:
TERMINATED
Last Update Posted:
2019-02-28
First Post:
2015-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of IMSI in Poor Responders to IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'DIfficulties with recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-27', 'studyFirstSubmitDate': '2015-02-04', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': 'Four to six weeks after embryo transfer', 'description': 'Percentage of patients presenting with presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound, per cycle initiated'}], 'secondaryOutcomes': [{'measure': 'Number of embryos obtained', 'timeFrame': 'Two days after egg retrieval', 'description': 'Total number of embryos obtained'}, {'measure': 'Percentage of cycles with embryo transfer', 'timeFrame': 'Two days after egg retrieval', 'description': 'Number of cycles reaching embryo transfer per cycle initiated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['POR', 'IMSI'], 'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'This is a pilot study which aims to determine the role of IMSI in poor responders.', 'detailedDescription': 'This is a pilot study which aims to determine the role of IMSI over ICSI in poor responders to IVF, without a background of teratozoospermia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '37 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* poor ovarian response\n\nExclusion Criteria:\n\n* body mass index (BMI) ≥ 30 kg/m2\n* presence of endocrinopathies (e.g., diabetes, hyperprolactinemia, hypothyroidism)\n* altered karyotype or documented genetic defects in one or both partners\n* history of chronic, autoimmune or metabolic diseases\n* altered meiosis in testicular biopsy or altered sperm-FISH\n* teratozoospermia\n* participation, simultaneously or within the previous 6 months, in another clinical trial with medication'}, 'identificationModule': {'nctId': 'NCT02358733', 'briefTitle': 'Use of IMSI in Poor Responders to IVF', 'organization': {'class': 'OTHER', 'fullName': 'Centro de Infertilidad y Reproducción Humana'}, 'officialTitle': 'Use of Intra-Cytoplasmic Morphologically Selected Sperm Injection (IMSI) in Poor Responders to In Vitro Fertilization (IVF): a Prospective, Double-blind, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'CIRH-BROIMSI-2014'}, 'secondaryIdInfos': [{'id': '2014-003928-50', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)', 'interventionNames': ['Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Intracytoplasmic sperm injection (ICSI)', 'interventionNames': ['Procedure: Intra-cytoplasmic Sperm Injection']}], 'interventions': [{'name': 'Intra-cytoplasmic Sperm Injection', 'type': 'PROCEDURE', 'description': 'Selection of sperm at 400x for sperm injection', 'armGroupLabels': ['Control']}, {'name': 'Intra-cytoplasmic Morphologically-selected Sperm Injection', 'type': 'PROCEDURE', 'description': 'Selection of sperm at 6000x for sperm injection', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Centro de Infertilidad y Reproducción Humana (CIRH)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Karinna Lattes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Infertilidad y Reproducción Humana (CIRH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Infertilidad y Reproducción Humana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}