Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:26 PM
Study NCT ID:
NCT05205733
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanding Fertility Care to Poor and Low Resourced Settings Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to complete either a mail-in or in-clinic semen analysis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the time to complete the semen analysis with in-clinic versus at-home testing.', 'timeFrame': '3 months after consented to the study.', 'description': 'The time to completion between in-clinic versus at-home testing will be identified when the provider obtains the results.'}], 'secondaryOutcomes': [{'measure': 'To identify barriers to completing a semen analysis.', 'timeFrame': 'Three months after being consented to the study.', 'description': 'The barriers will be identified via a survey to be completed by the participant.'}, {'measure': 'To compare barriers unique to completing an in-clinic versus at-home testing.', 'timeFrame': 'Three months after being consented to the study.', 'description': 'The unique barriers will be identified via a survey to be completed by the participant.'}, {'measure': 'To compare satisfaction scores with in-clinic versus at-home testing.', 'timeFrame': 'Three months after being consented to the study.', 'description': 'Patient satisfaction will be identified via a survey using the Likert Scale to be completed by the participant where strongly agree means very satisfied and strongly disagree is very unsatisfied.'}, {'measure': 'To compare the time to initiating treatment after completing in-clinic versus at-home testing.', 'timeFrame': 'Six months after being consented to the study.', 'description': 'The time to treatment initiation will be identified by the provider.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disparities', 'Resource limited', 'Low-resource communities'], 'conditions': ['Healthy', 'Male Infertility', 'Infertility, Male', 'Fertility Disorders']}, 'referencesModule': {'references': [{'pmid': '31778681', 'type': 'BACKGROUND', 'citation': 'Bradshaw A, Ballon-Landa E, Owusu R, Hsieh TC. Poor Compliance With Postvasectomy Semen Testing: Analysis of Factors and Barriers. Urology. 2020 Feb;136:146-151. doi: 10.1016/j.urology.2019.10.026. Epub 2019 Nov 26.'}, {'pmid': '25597249', 'type': 'BACKGROUND', 'citation': 'Practice Committee of the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile male: a committee opinion. Fertil Steril. 2015 Mar;103(3):e18-25. doi: 10.1016/j.fertnstert.2014.12.103. Epub 2015 Jan 15.'}, {'pmid': '31135764', 'type': 'BACKGROUND', 'citation': "Infertility Workup for the Women's Health Specialist: ACOG Committee Opinion, Number 781. Obstet Gynecol. 2019 Jun;133(6):e377-e384. doi: 10.1097/AOG.0000000000003271."}, {'pmid': '26364838', 'type': 'BACKGROUND', 'citation': 'Ethics Committee of the American Society for Reproductive Medicine. Disparities in access to effective treatment for infertility in the United States: an Ethics Committee opinion. Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.1139. Epub 2015 Sep 10.'}, {'pmid': '28874259', 'type': 'BACKGROUND', 'citation': 'Herndon CN, Anaya Y, Noel M, Cakmak H, Cedars MI. Outcomes from a university-based low-cost in vitro fertilization program providing access to care for a low-resource socioculturally diverse urban community. Fertil Steril. 2017 Oct;108(4):642-649.e4. doi: 10.1016/j.fertnstert.2017.06.035. Epub 2017 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'The investigators currently lack an understanding of barriers to completing the male factor infertility evaluation. Furthermore, as the investigators continue to expand access to fertility treatment particularly within low-resourced settings, it is important that all aspects of infertility within a couple are equally explored. The COVID-19 pandemic has disproportionately affected low-income communities and communities of color at greater rates in terms of not only disease morbidity/mortality but how medical systems are accessed and care is delivered.', 'detailedDescription': 'This pilot study was designed to help providers identify barriers to completing the basic infertility work-up in a low resource setting with a focus on accessibility and feasibility of semen analysis testing. As a pilot study, a total of 60 male partners of patients who are seeking infertility treatment at the Zuckerberg San Francisco General Hospital Gynecology clinic will be recruited. Participants will be randomized to completing a semen analysis by either the standard in-clinic test or an at-home sperm testing kit. The investigators hypothesis is that there will be an increase in participants completing their semen analysis when using the at-home sperm testing kit as opposed to having to come to the lab.\n\nSpecific Aims:\n\n1. To identify barriers to completing a semen analysis.\n2. To compare barriers unique to completing an in-clinic versus at-home testing.\n3. To compare satisfaction scores with in-clinic versus at-home testing.\n4. To compare the time to complete the semen analysis with in-clinic versus at-home testing.\n5. To compare the time to initiating treatment after completing in-clinic versus at-home testing.\n\nPatients seen at Zuckerberg San Francisco General who are currently undergoing an infertility evaluation as a part of the basic infertility assessment will be contacted. Consented participants will be randomized to complete an at home vs. lab semen analysis. After the semen analysis is completed, participants will be sent a comprehensive questionnaire regarding their experience, level of satisfaction, and barriers with completion of the recent semen analysis. Participants will be given 3 months to complete the semen analysis. If not completed in this timeframe, participants will be sent a different comprehensive questionnaire regarding their barriers with completion of the semen analysis. Additional clinical questions include time from semen analysis order to completion as well as time from semen analysis completion to start of treatment plan.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All English or Spanish speaking male partners of female patients undergoing an infertility work-up evaluation at Zuckerberg San Francisco General Hospital and recommended to undergo a semen analysis as a part of this workup.\n\nExclusion Criteria:\n\n* If they do not speak English or Spanish they will be excluded\n* If they are under the age of 18 y.o\n* If they are not recommended to undergo a semen analysis as a part of the infertility evaluation\n* If they are unable to produce a semen sample.'}, 'identificationModule': {'nctId': 'NCT05205733', 'acronym': 'EXPLORE', 'briefTitle': 'Expanding Fertility Care to Poor and Low Resourced Settings Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Expanding Fertility Care to Poor and Low Resourced Settings Study', 'orgStudyIdInfo': {'id': '21-33495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'In-Clinic Semen Analysis Testing', 'description': 'Men needing semen analysis for infertility work-up.'}, {'type': 'EXPERIMENTAL', 'label': 'No in-clinic semen analysis testing', 'description': 'Men needing semen analysis for infertility work-up.', 'interventionNames': ['Other: Mail-in semen analysis kit']}], 'interventions': [{'name': 'Mail-in semen analysis kit', 'type': 'OTHER', 'otherNames': ['Fellow Health Semen Analysis'], 'description': 'Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit', 'armGroupLabels': ['No in-clinic semen analysis testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alisha Tolani, MD', 'role': 'CONTACT', 'email': 'alisha.tolani@ucsf.edu', 'phone': '415-353-7475'}, {'name': 'Elena Hoskin', 'role': 'CONTACT', 'email': 'elena.hoskin@ucsf.edu', 'phone': '4153537475'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Alisha T Tolani, M.D.', 'role': 'CONTACT', 'email': 'alisha.tolani@ucsf.edu', 'phone': '415.353.7475'}], 'overallOfficials': [{'name': 'Yanett Anaya, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}