Expanding Fertility Care to Poor and Low Resourced Settings Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Expanding Fertility Care to Poor and Low Resourced Settings Study

Conditions
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Healthy, Male Infertility, Infertility, Male, Fertility Disorders

Intervention / Treatment
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* Other: Mail-in semen analysis kit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to complete either a mail-in or in-clinic semen analysis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: In-Clinic Semen Analysis Testing<br>Men needing semen analysis for infertility work-up. | |
| Experimental: No in-clinic semen analysis testing<br>Men needing semen analysis for infertility work-up. | Other: Mail-in semen analysis kit<br>* Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit<br>* Other names: Fellow Health Semen Analysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after consented to the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify barriers to completing a semen analysis. | The barriers will be identified via a survey to be completed by the participant. | 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. | 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. | 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. | Six months after being consented to the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disparities, Resource limited, Low-resource communities