Expanding Fertility Care to Poor and Low Resourced Settings Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To compare the time to complete the semen analysis with in-clinic versus at-home testing.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
In-Clinic Semen Analysis Testing
Men needing semen analysis for infertility work-up.
No in-clinic semen analysis testing
Men needing semen analysis for infertility work-up.
干预措施: Mail-in semen analysis kit (Other)
结局指标
主要结局
To compare the time to complete the semen analysis with in-clinic versus at-home testing.
时间窗: 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.
次要结局
- To identify barriers to completing a semen analysis.(Three months after being consented to the study.)
- To compare barriers unique to completing an in-clinic versus at-home testing.(Three months after being consented to the study.)
- To compare satisfaction scores with in-clinic versus at-home testing.(Three months after being consented to the study.)
- To compare the time to initiating treatment after completing in-clinic versus at-home testing.(Six months after being consented to the study.)