Expanding Fertility Care to Poor and Low Resourced Settings Study (EXPLORE)
Primary Purpose
Healthy, Male Infertility, Infertility, Male
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mail-in semen analysis kit
Sponsored by
About this trial
This is an interventional health services research trial for Healthy focused on measuring Disparities, Resource limited, Low-resource communities
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- If they do not speak English or Spanish they will be excluded
- If they are under the age of 18 y.o
- If they are not recommended to undergo a semen analysis as a part of the infertility evaluation
- If they are unable to produce a semen sample.
Sites / Locations
- University of California San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
In-Clinic Semen Analysis Testing
No in-clinic semen analysis testing
Arm Description
Men needing semen analysis for infertility work-up.
Men needing semen analysis for infertility work-up.
Outcomes
Primary Outcome Measures
To compare the time to complete the semen analysis with in-clinic versus at-home testing.
The time to completion between in-clinic versus at-home testing will be identified when the provider obtains the results.
Secondary Outcome Measures
To identify barriers to completing a semen analysis.
The barriers will be identified via a survey to be completed by the participant.
To compare barriers unique to completing an in-clinic versus at-home testing.
The unique barriers will be identified via a survey to be completed by the participant.
To compare satisfaction scores with in-clinic versus at-home testing.
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.
To compare the time to initiating treatment after completing in-clinic versus at-home testing.
The time to treatment initiation will be identified by the provider.
Full Information
NCT ID
NCT05205733
First Posted
January 11, 2022
Last Updated
January 17, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05205733
Brief Title
Expanding Fertility Care to Poor and Low Resourced Settings Study
Acronym
EXPLORE
Official Title
Expanding Fertility Care to Poor and Low Resourced Settings Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
Specific Aims:
To identify barriers to completing a semen analysis.
To compare barriers unique to completing an in-clinic versus at-home testing.
To compare satisfaction scores with in-clinic versus at-home testing.
To compare the time to complete the semen analysis with in-clinic versus at-home testing.
To compare the time to initiating treatment after completing in-clinic versus at-home testing.
Patients 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Male Infertility, Infertility, Male, Fertility Disorders
Keywords
Disparities, Resource limited, Low-resource communities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to complete either a mail-in or in-clinic semen analysis.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-Clinic Semen Analysis Testing
Arm Type
No Intervention
Arm Description
Men needing semen analysis for infertility work-up.
Arm Title
No in-clinic semen analysis testing
Arm Type
Experimental
Arm Description
Men needing semen analysis for infertility work-up.
Intervention Type
Other
Intervention Name(s)
Mail-in semen analysis kit
Other Intervention Name(s)
Fellow Health Semen Analysis
Intervention Description
Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit
Primary Outcome Measure Information:
Title
To compare the time to complete the semen analysis with in-clinic versus at-home testing.
Description
The time to completion between in-clinic versus at-home testing will be identified when the provider obtains the results.
Time Frame
3 months after consented to the study.
Secondary Outcome Measure Information:
Title
To identify barriers to completing a semen analysis.
Description
The barriers will be identified via a survey to be completed by the participant.
Time Frame
Three months after being consented to the study.
Title
To compare barriers unique to completing an in-clinic versus at-home testing.
Description
The unique barriers will be identified via a survey to be completed by the participant.
Time Frame
Three months after being consented to the study.
Title
To compare satisfaction scores with in-clinic versus at-home testing.
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.
Time Frame
Three months after being consented to the study.
Title
To compare the time to initiating treatment after completing in-clinic versus at-home testing.
Description
The time to treatment initiation will be identified by the provider.
Time Frame
Six months after being consented to the study.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
If they do not speak English or Spanish they will be excluded
If they are under the age of 18 y.o
If they are not recommended to undergo a semen analysis as a part of the infertility evaluation
If they are unable to produce a semen sample.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisha T Tolani, M.D.
Phone
415.353.7475
Email
alisha.tolani@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Aileen Portugal, M.D.
Phone
415.353.7475
Email
aileen.portugal@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanett Anaya, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aileen Portugal, MD
Phone
619-993-4298
Email
aileen.portugal@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31778681
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.
Results Reference
background
PubMed Identifier
25597249
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.
Results Reference
background
PubMed Identifier
31135764
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.
Results Reference
background
PubMed Identifier
26364838
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.
Results Reference
background
PubMed Identifier
28874259
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.
Results Reference
background
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Expanding Fertility Care to Poor and Low Resourced Settings Study
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