Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06880302
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2025-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Male Infertility and Assisted Reproductive Technologies Research Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. Buccal swabs will also be collected if participants decide to participate in sub-study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biobank', 'timeFrame': '5 years', 'description': 'The purpose of this study is to create a biobank of male biological specimens'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Infertility', 'Infertility (IVF Patients)']}, 'descriptionModule': {'briefSummary': 'The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART).', 'detailedDescription': 'The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART). These specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. These samples were possibly utilized for diagnostic testing such as semen analyses or DNA fragmentation testing or for ART procedures such as intrauterine insemination (IUI) in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) and are no longer needed clinically. Rather than discarding those samples the men who provided them or the sperm recipient in the case of donor sperm may elect to donate them for future research purposes. These samples will be used for future research regarding male infertility and assisted reproductive technologies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males that had previously provided male biological specimen for their infertility treatment that no longer wishes to keep their samples frozen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males providing testicular tissue, sperm, semen samples, discarded sperm preps for IUI/IVF/ICSI or the sperm recipient for those utilizing donor sperm, for cryopreservation at the respective site(s) for either clinical use or preservation\n\nExclusion Criteria:\n\n* Samples that are quarantined or in isolation dewars for infectious diseases'}, 'identificationModule': {'nctId': 'NCT06880302', 'acronym': 'MARK', 'briefTitle': 'Male Infertility and Assisted Reproductive Technologies Research Biobank', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Male Infertility and Assisted Reproductive Technologies Research Biobank', 'orgStudyIdInfo': {'id': 'RMA-2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Males providing specimen for infertility treatment', 'description': 'Males providing specimen for infertility treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caroline Zuckerman, BS BSN RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@ivirma.com', 'phone': '9736562841'}], 'facility': 'RMANJ', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'centralContacts': [{'name': 'Caroline Zuckerman, RN BSN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@ivirma.com', 'phone': '9736562841'}, {'name': 'Christine Whitehead, MS, BSN, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@ivirma.com', 'phone': '9736562841'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}