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

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    60
  • sponsor
    University of California, San Francisco
Updated on 17 June 2022
Accepts healthy volunteers

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.

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.

Details
Condition Healthy, Male Infertility, Infertility, Male, Fertility Disorders
Treatment Mail-in semen analysis kit
Clinical Study IdentifierNCT05205733
SponsorUniversity of California, San Francisco
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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