Expanding Fertility Care to Poor and Low Resourced Settings Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2024-06-30

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.

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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:

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.

Conditions

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Healthy Male Infertility Infertility, Male Fertility Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to complete either a mail-in or in-clinic semen analysis.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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In-Clinic Semen Analysis Testing

Men needing semen analysis for infertility work-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

No in-clinic semen analysis testing

Men needing semen analysis for infertility work-up.

Group Type EXPERIMENTAL

Mail-in semen analysis kit

Intervention Type OTHER

Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit

Interventions

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Mail-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

Intervention Type OTHER

Other Intervention Names

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Fellow Health Semen Analysis

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes