HealthyEXPLORENCT05205733
Expanding Fertility Care to Poor and Low Resourced Settings Study
A study testing Mail-in semen analysis kit in people with Healthy and Male Infertility, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Male Infertility, Infertility, Male
- What is being tested?
- Mail-in semen analysis kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94107
Alisha Tolani, MD, 415-353-7475, alisha.tolani@ucsf.edu
Elena Hoskin, 4153537475, elena.hoskin@ucsf.edu
About this study
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.
Read the 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.
- Conditions
- Healthy, Male Infertility, Infertility, Male, Fertility Disorders
- Being tested
- Mail-in semen analysis kit
- Keywords
- Disparities, Resource limited, Low-resource communities
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mail-in semen analysis kitOther
Also called Fellow Health Semen Analysis
Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit
| Study group | Role | What they receive |
|---|---|---|
| In-Clinic Semen Analysis Testing | No intervention | Men needing semen analysis for infertility work-up. |
| No in-clinic semen analysis testing | Experimental | Men needing semen analysis for infertility work-up. Receives: Other: Mail-in semen analysis kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after consented to the study.
Secondary outcomes (4)
To identify barriers to completing a semen analysis.
The barriers will be identified via a survey to be completed by the participant.
Measured: Three months after being consented to the study.
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.
Measured: Three months after being consented to the study.
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.
Measured: Three months after being consented to the study.
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.
Measured: Six months after being consented to the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start24 May 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to complete either a mail-in or in-clinic semen analysis.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanett Anaya, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205733
- Sponsor's protocol ID
- 21-33495
- Acronym
- EXPLORE
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31778681Practice 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.
PubMed 25597249Infertility 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.
PubMed 31135764Ethics 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.
PubMed 26364838Herndon 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.
PubMed 28874259
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Fertility Care to Poor and Low Resourced Settings Study
- ClinicalTrials.gov ID
- NCT05205733
- Acronym / sponsor ID
- EXPLORE / 21-33495
- Conditions
- Healthy, Male Infertility, Infertility, Male, Fertility Disorders
- Keywords
- Disparities, Resource limited, Low-resource communities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to complete either a mail-in or in-clinic semen analysis.
| Arm | Type | Receives |
|---|---|---|
| In-Clinic Semen Analysis Testing | No intervention | –Men needing semen analysis for infertility work-up. |
| No in-clinic semen analysis testing | Experimental | Other: Mail-in semen analysis kitMen needing semen analysis for infertility work-up. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mail-in semen analysis kitAlso: Fellow Health Semen AnalysisPresumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit | Other | No in-clinic semen analysis testing |
Primary outcome
To compare the time to complete the semen analysis with in-clinic versus at-home testing.
Time frame: 3 months after consented to the study.
The time to completion between in-clinic versus at-home testing will be identified when the provider obtains the results.
4 secondary outcomes
To identify barriers to completing a semen analysis.
Time frame: Three months after being consented to the study.
To compare barriers unique to completing an in-clinic versus at-home testing.
Time frame: Three months after being consented to the study.
To compare satisfaction scores with in-clinic versus at-home testing.
Time frame: Three months after being consented to the study.
To compare the time to initiating treatment after completing in-clinic versus at-home testing.
Time frame: Six months after being consented to the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 31778681Bradshaw 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.
- Background: PubMed 25597249Practice 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.
- Background: PubMed 31135764Infertility 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.
- Background: PubMed 26364838Ethics 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.
- Background: PubMed 28874259Herndon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanett Anaya, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mail-in semen analysis kit in people with Healthy and Male Infertility, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alisha T Tolani, M.D. (415.353.7475, alisha.tolani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the time to complete the semen analysis with in-clinic versus at-home testing. (time frame: 3 months after consented to the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205733, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.