Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT01729533
Status:
WITHDRAWN
Last Update Posted:
2014-11-18
First Post:
2012-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2012-11-14', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '1 month', 'description': 'Number of pregnancies divided by the number of cycles with embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICSI', 'IMSI', 'Pregnancy', 'Sperm morphology', 'Unexplained infertility'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The (motile sperm organelle morphology examination) MSOME allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.\n\nThe investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)', 'detailedDescription': "When routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. These couples present normal semen analysis.\n\nIt has been reported that even infertile patients with normozoospermic parameters can have higher values of DNA damage than fertile controls.\n\nIt has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates.\n\nThe motile sperm organelle morphology examination (MSOME) allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.\n\nThe investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of good physical and mental health\n* Undergoing assisted reproduction as a result of unexplained infertility\n* Women with regular menstrual cycles of 25-35 days\n* Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels\n* Women with body mass index (BMI) less than 30 kg/m2\n* Women with both ovaries and intact uterus\n\nExclusion Criteria:\n\n* Men with abnormal semen parameters according to the 2010 WHO values\n* Women with polycystic ovaries\n* Women with endometriosis\n* Women with gynaecological/medical disorders\n* Women or men with a positive result for sexually transmitted diseases\n* Women who had received hormone therapy for at least 60 days preceding the study'}, 'identificationModule': {'nctId': 'NCT01729533', 'briefTitle': 'The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Sapientiae Institute'}, 'officialTitle': 'The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility', 'orgStudyIdInfo': {'id': 'IMSI_unexplained infertility'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ICSI', 'description': 'In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.', 'interventionNames': ['Other: ICSI']}, {'type': 'EXPERIMENTAL', 'label': 'IMSI', 'description': 'In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.', 'interventionNames': ['Other: IMSI']}], 'interventions': [{'name': 'ICSI', 'type': 'OTHER', 'otherNames': ['Intracytoplasmic sperm injection'], 'description': 'ICSI Sperm selection in the ICSI group is analyzed under a magnification of 400x using an inverted microscope. ICSI is performed in a micro-injection dish prepared with 4 µL droplets of buffered medium and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.', 'armGroupLabels': ['ICSI']}, {'name': 'IMSI', 'type': 'OTHER', 'otherNames': ['Intracytoplasmic morphologically selected sperm injection'], 'description': 'Sperm selection in the IMSI group is analyzed at high magnification using an inverted microscope equipped with high-power differential interference contrast optics. The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei (\\[1\\] smooth, \\[2\\] symmetric, and \\[3\\] oval configuration) and \\[4\\] normal nuclear chromatin content (if it contained no more than one vacuole, which occupies \\<4% of the nuclear area) are selected for injection.', 'armGroupLabels': ['IMSI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04503040', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Sapientiae Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sapientiae Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}