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

February 15, 2024 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Fellow Health Semen Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after consented to the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months after being consented to the study.
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.
Three months after being consented to the study.
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.
Three months after being consented to the study.
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.
Six months after being consented to the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Yanett Anaya, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-33495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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