Fertility Disorders, Healthy, Infertility, Male, Male Infertility
Conditions
Keywords
Disparities, Resource limited, Low-resource communities
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: 1. To identify barriers to completing a semen analysis. 2. To compare barriers unique to completing an in-clinic versus at-home testing. 3. To compare satisfaction scores with in-clinic versus at-home testing. 4. To compare the time to complete the semen analysis with in-clinic versus at-home testing. 5. 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.
Interventions
OTHERMail-in semen analysis kit
Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants are assigned to complete either a mail-in or in-clinic semen analysis.
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the time to complete the semen analysis with in-clinic versus at-home testing. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To identify barriers to completing a semen analysis. | Three months after being consented to the study. | 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. | Three months after being consented to the study. | 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. | Three months after being consented to the study. | 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. | Six months after being consented to the study. | The time to treatment initiation will be identified by the provider. |
Countries
United States
Contacts
Primary ContactAlisha T Tolani, M.D.
Outcome results
None listed