Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive
Phase: NA
Conditions: Male Infertility
Sponsor: Northwestern University

STU#: STU00216874
Version Date:  2.21.2022
Page 1 of 8
HRP-593 / v05202020
PROTOCOL TITLE: Randomized Controlled Trial of Home Semen Testing in Men Beginning 
Attempts to Conceive
PRINCIPAL INVESTIGATOR:
Joshua Halpern, MD MS
Department of Urology
Joshua.halpern@northwestern.edu
VERSION DATE:
2.21.22
 
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
IND / IDE / HDE # 
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
200
Funding Source
Department of Urology
Indicate the type of consent 
to be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site (For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
OBJECTIVES:
The overall objective of the proposed study is to enhance early detection of male factor infertility 
and reduce cost and morbidity associated with delayed diagnosis through development of a 
universal screening model based on home semen testing. The advent of inexpensive and 
accurate home semen testing has enabled a potential paradigm shift in the approach to male 
fertility evaluation. Our central hypothesis is that universal home semen testing prior to attempts 
to conceive is easy for patients and can lead to reduced fertility-related anxiety and early 
detection of male factor infertility, thereby expediting evaluation and treatment for the couple 
while minimizing unnecessary cost and morbidity.
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 2 of 8
HRP-593 / v05202020
This study is specifically designed to assess the feasibility and utility of home semen testing for 
couples who are beginning attempts to conceive. First, we will assess patients’ ability to 
complete the home semen testing, ease of use, and obstacles encountered in doing so. 
Second, we will examine the impact of home semen testing in fertility-related quality of life 
among couples beginning attempts to conceive, as well as ability of home semen testing to 
increase the diagnosis and treatment of male infertility in these couples.
BACKGROUND:
Infertility affects 15% of all couples in the United States, and successful diagnosis and treatment 
costs an average of up to $50,000 per couple. Approximately half of all infertile couples have a 
male factor etiology, yet male partner evaluation is disproportionately bypassed with an 
estimated 860,000 male partners not evaluated at the time of fertility consultation. While 
American Society for Reproductive Medicine (ASRM) guidelines recommend that couples do 
not seek evaluation until attempting to conceive for 12 months, most couples attempt to 
conceive for 22.3 months before presentation for male fertility evaluation, almost a year in 
delayed diagnosis. This delay in diagnosis and treatment can impair quality of life, impact 
treatment outcomes, and increase overall healthcare costs. Infertile couples are at greater risk 
of marital stress, sexual dysfunction, and decreased quality of life, which may extend even to 
this initial 12-month period. Furthermore, morbidity and costs associated with extensive female 
partner evaluation could be reduced or altogether avoided with earlier male factor detection. 
There is a critical need to develop practical interventions which can easily be implemented into 
practice in order to increase access to care for male infertility evaluation and treatment. 
Our prior work has shown that accessibility of male infertility providers and semen testing are 
key barriers to care access. We surveyed men (N=634) without children to understand attitudes 
towards fertility and home semen testing. Among men concerned about infertility, only 29% 
were likely to discuss these concerns with a health care provider. Moreover, men were more 
likely to pursue home semen testing versus laboratory based semen testing (p=0.04). These 
data indicate a critical role for home screening to detect subfertility in men who might otherwise 
not pursue evaluation in a timely fashion. 
The rapid proliferation and wide accessibility of inexpensive and accurate home semen tests 
has the potential to overcome the aforementioned barriers towards initial male fertility 
evaluation. In our prior survey, we found that men were more likely to pursue home semen 
testing versus laboratory based semen testing (p=0.04). These data indicate a critical role for 
home screening to detect subfertility in men who might otherwise not pursue evaluation in a 
timely fashion. As such, we conducted a cost-effectiveness analysis to evaluate the theoretical 
benefits of universal home screening for men pursuing fertility. We found that a policy of 
universal home screening would result in significant decreases in time to diagnosis at a very 
limited cost. These data provide the basis for the current study, which aims to examine home 
semen testing as a screening tool for all couples planning to conceive.
STUDY ENDPOINTS:
Primary: 
1.
Completion of home semen testing (Arm A:treatment group only)
2.
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5) and 
Fertility Problem Inventory (FPI). 
Secondary:
1.
Subsequent pursuit of formal male infertility evaluation
2.
Pregnancy
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 3 of 8
HRP-593 / v05202020
STUDY INTERVENTION(S) / INVESTIGATIONAL AGENT(S):
We will be conducting this study in partnership with the home semen testing YoSperm® device, 
a commercially available FDA-approved device to assess semen parameters via smart device, 
a mobile medical application (MMA) designed by Medical Electronic Systems. We plan to work 
with the YoSperm® device to complete at home semen testing. Eligible patients will be 
randomized to one of two arms: standard of care office-based pathway or the at home semen 
testing pathway utilizing the FDA, commercially approved YoSperm® device. 
YoSperm® details:
Purpose of the app:
The purpose of the app is for at-home semen analysis including sperm motility concentration 
and sperm quality (YO Score) and compares the results to laboratory standards. We will be 
utilizing the YoSperm® technology in order for patients to send their semen analysis results 
directly from their device to their provider via secure email.
The app is appropriately suited for adults 18 and older and is aesthetically easy to read/navigate 
and easy to understand.
App functionality:
YO 2.0 can be accessed via URL link (https://yospermtest.com/download-yo-home-sperm-
test-app) to their website using any computer with Internet capability. It can also be accessed in 
app format and can be downloaded onto iOS or Android devices via Google Play and Apple App 
Store. The app is free and there is no cost to the participant. Participants will use their own 
devices for the study. Participants without mobile phone/computer capability to utilize 
YoSperm® app will be excluded from the study. YoSperm® has technical support available on 
their website with Frequently Asked Questions as well as on demand technical support via a 
Customer Support Ticket (https://yospermtest.com/support/) or email 
support@yospermtest.com for any participants with app related technical issues. When a 
device’s operating system is updated, the app’s functionality will not be impacted. However, 
YoSperm® mobile app does require iOS 11 or later or Android 6.0+. The PC operating system 
must be Windows 7 or above or MAC OS version 10.14 and above. 
Participant/user support:
Participants will be trained to use the app and device during their initial in person visit if they 
choose to sign up for the study and are randomized to the YoSperm® device. In addition, the 
app provides a tutorial for usage when first downloaded. Participants have access YoSperm® 
has technical support available on their website with Frequently Asked Questions as well as on 
demand technical support via a Customer Support Ticket (https://yospermtest.com/support/) or 
email support@yospermtest.com for any participants with app related technical issues. 
Participants will be able to message providers with questions regarding the app or regarding 
their care through via Epic myChart. 
Obtaining consent and the app’s Terms of Service:
We will obtain written consent during a patient’s initial appointment. Participants will not be 
consented via the app. YoSperm® Terms of Service, which are located on their website. Data 
ownership is outlined in the Data Privacy Policy, which is also available on YoSperm®’s 
website. All data collected and provided by participants is owned by Medical Electronic Systems 
Limited. The Terms of Service will be summarized in the IRB consent form in a participant 
friendly manner. The Terms of Service are compliant with research regulations and 
local/state/federal law. We will plan to monitor for changes or updates to the Terms of Services 
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 4 of 8
HRP-593 / v05202020
by visiting the Website for updates. 
Privacy and confidentiality protections:
Medical Electronic Systems Limited collects and processes the following data. Optional Profile 
Data, Contact Data, and Communications Data. Your data and information is stored securely in 
Firebase, Bigquery and Mongo DB. The data stored is on secure cloud services and running in 
the United States. Firebase and Bigquery are part of Google. Google and MongoDB are 
organizations committed to privacy and have stated that the model clause relating to transfer of 
data between the European Union and the United States are compliant with GDPR. Data is also 
compiled and maintained in an encrypted REDCap database through our institution. Data will be 
accessible only to authorized members of the study team. YoSperm® does require a username 
and password for each individual. Usernames are generated by the user. If a participant forgets 
their username and/or password, there are links in which participants can receive a 
username/password reset sent to their email. 
Risks related to app use:
YoSperm® Data Privacy Policy is available on their website and attached with this protocol. All 
efforts will be made to protect data; however, no method of transmission over the internet or 
electronic storage is 100% secure. If the app does not work as intended or malfunctions, 
participants can contact the Customer Support urgently (support@yospermtest.com). Patients 
will also have the option to ask care-related concerns through Epic MyChart. All information in 
this study is kept confidential between the study team and the participants. 
PROCEDURES INVOLVED:
Visit 1 – Screening (Day -45 – Day 0)
1.
Patients will complete:
a.
Patient Informed Consent Form
b.
HIPAA Form
c.
Intake questionnaire 
d.
WHO-5 
e.
FPI 
2.
Investigative team will complete:
a.
Patient demographics, medical history, inclusion / exclusion criteria
b.
Randomization 
i.
:At Home Semen Testing
1.
Provision of home semen testing kit to men selected for the 
testing group
2.
Instructions in the use of home semen testing kit
ii.
Standard of Care
Visit 2 – Home semen testing (Day 0) 
1.
Only patients randomized to at home semen testing will complete:
a.
Home semen testing (testing group only)
b.
Patient will send home semen test results to the study team via the application
c.
Patient will complete the post-test survey via REDCap
2.
Investigative team will complete:
a.
Recording of home semen test results
b.
Confirm completion of post-test survey
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 5 of 8
HRP-593 / v05202020
Visit 3 – Three-month follow-up (Day 90) 
1.
Patients randomized to either at home semen testing or standard of care will complete:
a.
WHO-5 
b.
FPI 
c.
Follow-up fertility questionnaire 
2.
Investigative team will complete:
a.
Confirm completion of questionnaires 
Visit 4 – Six-month follow-up (Day 180) 
1.
Patients randomized to either at home semen testing or standard of care will complete:
a.
WHO-5 
b.
FPI 
c.
Follow-up fertility questionnaire 
2.
Investigative team will complete:
a.
Confirm completion of questionnaires 
Visit 5 – Twelve-month follow-up (Day 365) 
1.
Patients randomized to either at home semen testing or standard of care will complete:
a.
WHO-5 
b.
FPI 
c.
Follow-up fertility questionnaire 
2.
Investigative team will complete:
a.
Confirm completion of questionnaires 
Home semen testing will be performed via the YoSperm® device, a commercially available 
FDA-approved device to assess semen parameters via smart device (https://yospermtest.com/). 
The YoSperm® technology enables patients to send results directly from their device to their 
provider via secure email. 
Randomization will be performed in 1:1 fashion to the home testing or control groups using 
REDCap.
All surveys will be administered via REDCap
DATA AND SPECIMEN BANKING
Data will be collected and stored electronically in REDCap.  Quality assurance steps will include 
testing of database including any potential data calculated by command functions within 
REDCap by the study team prior to moving to production mode. The following quality control 
methods will be used: 1) single entry of data with random checks of accuracy, and 2) extraction 
and cleaning of data on a monthly basis that will be used for analysis every 3 months until 
completion of enrollment.
Clinical variables from the medical record may be abstracted if additional data is needed to 
evaluate the survey responses. These variables may include lab tests and results, medical 
history, family history, and clinical examinations. Dr. Halpern will have access to the codebook 
with patient identifiers, which will be stored on the FSM server and only accessible to authorized 
members of the study team listed on this protocol.
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 6 of 8
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Data will be accessible to only authorized members of the study team. Any presentations on the 
study or published findings will use only de-identified data. 
Data will be stored for 7 years after the end of the study. After this period, electronic data will be 
deleted. 
SHARING RESULTS WITH PARTICIPANTS
Study results will not be shared with participants.
INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria

Natal males over the age of 18 with no prior children who are interested in future 
fertility

Current female partner

Not attempting to conceive for more than 3 months

Willing to sign the Informed Consent Form 

Able to read, understand, and complete patient questionnaires, pain texts, and 
medication diary.

Ownership or accessibility of a smart phone or electronic device that is compatible 
with the YoSperm® device
Exclusion Criteria

Prior semen testing

History of male infertility, Klinefelter syndrome, undescended testis, or chemotherapy

Female partner with history of infertility

Female partner with irregular menstrual periods
PARTICIPANT POPULATION(S)
Accrual 
Number:
Category/Group:
(Adults/Children 
Special/Vulnerable 
Populations)
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
0
200
200
Local
0
200
200
Study-wide
Total:
0
200
200
RECRUITMENT METHODS
Recruitment will be accomplished through institutional outreach using a combination of 
institutional advertising (flyers) and partnership with primary care providers throughout 
Northwestern Medicine. Patients will be offered compensation for study enrollment and at study 
completion.
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 7 of 8
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A research coordinator will work closely with the primary care, OBGYN, and Urology teams to 
screen, recruit and enroll patients in this trial; the Department of Urology at Northwestern 
University employs multiple full-time research coordinators for assistance with clinical trials 
recruitment and coordination.
Enrollment into the study will be performed by a qualified research coordinator or member of the 
authorized study team. Patients expressing interest in the study will reach out to the study 
coordinator directly and undergo an initial screening assessment and completion of the intake 
questionnaires and consent. Patients enrolled will then schedule a separate appointment with 
the research coordinator, at which point they will undergo randomization and receive instruction 
and teaching in use of home semen testing if they are randomized to the testing group. 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
Patients will be compensated $20 for participating at the time of enrollment. An additional $20 
will be compensated at the time of study completion. 
WITHDRAWAL OF PARTICIPANTS
If a subject wishes to withdraw from the study, he may do so by verbal request to the research 
team. A subject may be withdrawn from the study by a physician-investigator if determined to be 
in the subject’s best interest for medical reasons.
RISKS TO PARTICIPANTS
There is no risk to participants in this study from the testing or questionnaires. There is a small 
potential for adverse mental health consequences (anxiety) of an abnormal semen test, if this is 
detected among men in the study group. 
POTENTIAL BENEFITS TO PARTICIPANTS
Participants may have substantial benefit through early detection of semen parameter 
abnormalities, which can lead to early diagnosis and treatment of male infertility.
DATA MANAGEMENT AND CONFIDENTIALITY
Data will be collected and stored electronically in REDCap.  Quality assurance steps will include 
testing of database including any potential data calculated by command functions within 
REDCap (ex: age of patient at time of surgery calculated by using patient’s date of birth and 
date of surgery) by study team prior to moving to production mode.  The following quality control 
methods will be used: 1) single entry of data with random checks of accuracy, and 2) extraction 
and cleaning of data on a monthly basis that will be used for analysis every 3 months until 
completion of enrollment.
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
Data will be collected and stored electronically in REDCap and will only be accessible to 
members of the study team. 
Data resulting from this study will not be linked to subjects. Subjects will not be referred to by 
name of initial in any publications. 
CONSENT PROCESS
Enrollment into the study will be performed by a qualified research coordinator. Patients 
expressing interest in the study will reach out to the study coordinator directly and undergo 
consent. 
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.

STU#: STU00216874
Version Date:  2.21.2022
Page 8 of 8
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PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
HIPAA authorization will be obtained as part of the consent. PHI from medical records and 
information collected from research and tumor samples will be protected by using coded subject 
numbers. The coded identifiers will be stored on a password protected spreadsheet stored on 
the FSM Urology server.
IRB #: STU00216874 Approved by NU IRB for use on or after 5/24/2022 through 5/23/2023.