Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT07268235
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Timing of Oocyte Retrieval and Micro Testicular Sperm Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564665', 'term': 'Azoospermia, Nonobstructive'}, {'id': 'D009845', 'term': 'Oligospermia'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of live births following ICSI with micro-TESE either 24 or 48 hours prior to oocyte retrieval', 'timeFrame': 'For IVF performed from June 2015 to January 2025'}], 'secondaryOutcomes': [{'measure': 'Percentage of fertilized oocytes with two pronuclei (2PN)', 'timeFrame': 'For IVF performed from June 2015 to January 2025'}, {'measure': 'Percentage of usable blastocyst (defined as frozen and transferred blastocysts)', 'timeFrame': 'For IVF performed from June 2015 to January 2025'}, {'measure': 'Pregnancy rate based on positive β-hCG', 'timeFrame': 'For IVF performed from June 2015 to January 2025'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonobstructive Azoospermia', 'oligoasthenoteratozoospermia', 'intracytoplasmic sperm injection', 'In vitro fertilization', 'cryptozoospermia'], 'conditions': ['Microdissection Testicular Sperm Extraction']}, 'descriptionModule': {'briefSummary': 'This is a retrospective study to assess outcomes of micro-TESE performed 24 or 48 hours before oocyte retrieval and ICSI.', 'detailedDescription': 'This retrospective study evaluates patients undergoing ICSI following micro-TESE. Participants are assigned to two groups based on the interval between sperm extraction and oocyte retrieval (24 vs. 48 hours). Clinical and embryological outcomes from the first embryo transfer will be assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men who underwent a micro-TESE for IVF treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who underwent a micro-TESE at the OVO clinic from June 2015 to January 2025.\n* Patients with non-obstructive azoospermia (NOA), (absence of spermatozoa in multiple semen analyses)\n* Patients with cryptozoospermia, (presence of a small number of spermatozoa detectable only after semen centrifugation)\n* Patients with oligoasthenoteratozoospermia (OAT), (sperm concentration of less than 15 million/mL, reduced motility and abnormal morphology)\n\nExclusion Criteria:\n\n* Patients who did not have any sperm noted following micro-TESE\n* Use of donor sperm or oocytes\n* Frozen sperm or oocytes\n* Same day oocyte retrieval and sperm extraction\n* Reversible cause of cryptozoospermia (i.e presence of a varicocele, febrile illness, or recent toxin exposure) Partial genital tract obstruction (i.e post-vaso-vasostomy, post-vasoepididymostomy, and low volume cryptozoospermia with ejaculatory duct obstruction)'}, 'identificationModule': {'nctId': 'NCT07268235', 'briefTitle': 'Timing of Oocyte Retrieval and Micro Testicular Sperm Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinique Ovo'}, 'officialTitle': 'Timing of Oocyte Retrieval and Micro Testicular Sperm Extraction: Does it Make a Difference? A Single-center Retrospective Cohort', 'orgStudyIdInfo': {'id': 'Micro-TESE'}}, 'contactsLocationsModule': {'locations': [{'zip': 'H4P 2S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique ovo', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Isaac-Jacques Kadoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Ovo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Ovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}