Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:26 PM
Study NCT ID:
NCT05205733
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanding Fertility Care to Poor and Low Resourced Settings Study
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Expanding Fertility Care to Poor and Low Resourced Settings Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPLORE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: