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Expanding Fertility Care to Poor and Low Resourced Settings Study (EXPLORE)

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ClinicalTrials.gov Identifier: NCT05205733
Recruitment Status : Recruiting
First Posted : January 25, 2022
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Healthy Male Infertility Infertility, Male Fertility Disorders Other: Mail-in semen analysis kit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to complete either a mail-in or in-clinic semen analysis.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Expanding Fertility Care to Poor and Low Resourced Settings Study
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
No Intervention: In-Clinic Semen Analysis Testing
Men needing semen analysis for infertility work-up.
Experimental: No in-clinic semen analysis testing
Men needing semen analysis for infertility work-up.
Other: 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
Other Name: Fellow Health Semen Analysis




Primary Outcome Measures :
  1. To compare the time to complete the semen analysis with in-clinic versus at-home testing. [ Time Frame: 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 Outcome Measures :
  1. To identify barriers to completing a semen analysis. [ Time Frame: Three months after being consented to the study. ]
    The barriers will be identified via a survey to be completed by the participant.

  2. To compare barriers unique to completing an in-clinic versus at-home testing. [ Time Frame: Three months after being consented to the study. ]
    The unique barriers will be identified via a survey to be completed by the participant.

  3. To compare satisfaction scores with in-clinic versus at-home testing. [ Time Frame: 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.

  4. To compare the time to initiating treatment after completing in-clinic versus at-home testing. [ Time Frame: Six months after being consented to the study. ]
    The time to treatment initiation will be identified by the provider.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05205733


Contacts
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Contact: Jerrine Morris, M.D., MPH 415.353.7475 jerrine.morris@ucsf.edu
Contact: Aileen Portugal, M.D. 415.353.7475 aileen.portugal@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94107
Contact: Aileen Portugal, MD    619-993-4298    aileen.portugal@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Yanett Anaya, M.D. University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05205733    
Other Study ID Numbers: 21-33495
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Disparities
Resource limited
Low-resource communities
Additional relevant MeSH terms:
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Infertility
Infertility, Male