Male InfertilityNCT05503862

Home Semen Testing in Men Beginning Attempts to Conceive

A study testing YoSperm in people with Male Infertility, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Male Infertility
What is being tested?: YoSperm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: 17 Aug 2022to 16 Oct 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University Department of Urology
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive

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. The investigator's central hypothesis is that universal home semen testing prior to attempts to conceive is easy for participants 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.

This study is specifically designed to assess the feasibility and utility of home semen testing for couples who are beginning attempts to conceive. First, the investigator will assess participants' ability to complete the home semen testing, ease of use, and obstacles encountered in doing so. Second, the investigator 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.

Conditions: Male Infertility
Being tested: YoSperm
Medical subject headings: Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YoSpermDevice
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.

Study groups in NCT05503862
Study group	Role	What they receive
Arm A	Experimental	At home semen testing via the YoSperm device Receives: Device: YoSperm
Arm B	No intervention	Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Completed the Home Semen Testing
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Measured: Device mailed to patient immediately following randomization
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Fertility Quality of Life (FertiQoL) Core Score. FertiQoL is a measure of fertility-related quality of life. The total score reported in this study was derived from the Emotional, Mind-Body, Relational, and Social domains. Scores range from 0 to 100, with higher scores indicating better fertility-related quality of life and lower scores indicating worse fertility-related quality of life. Unit of measure: scores on a scale.
Subscale and total scoring:
Scoring consists of three steps.
1. Reverse items.
2. Calculate raw scores by summing all items that belong to the subscale or total scale. For the Core FertiQoL add all 'Q' items (24 items). For the Treatment FertiQoL add all the 'T' items (10 items). For the Total FertiQoL add all Core and Treatment items (34 items).
3. To compute scaled scores for the subscale and total scales, multiply the relevant raw score by 25/k, where k is the number of items in the subscale. The scaled scores range is 0 to 100.
Measured: Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2) after baseline.
Change in Fertility-related WHO-5 Questionnaire
To assess participant's well-being as it relates to their fertility
World Health Organization Five Well-Being Index (WHO-5). The WHO-5 is a 5-item measure of current psychological well-being. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better psychological well-being and lower scores indicating worse psychological well-being. Unit of measure: scores on a scale
Measured: Original occurred at baseline. Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2)

Secondary outcomes (8)

Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire administered approximately 3 months after baseline. The questionnaire assessed pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.
Measured: 60-120 days after baseline
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire administered approximately 3 months after baseline. The questionnaire assessed pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.
Measured: 3 months
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire collected between 300 and 425 days after baseline. Outcomes included pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.
Measured: 300-425 days
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire collected from 367 to 967 days after baseline. Outcomes included pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.
Measured: 367 to 967 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1
Continuation of the Fertility Questionnaire
Measured: 60-120 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2
Continuation of the Fertility Questionnaire
Measured: 60-150 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1
Continuation of the Fertility Questionnaire
Measured: 300-425 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2
Continuation of the Fertility Questionnaire
Measured: 367 to 967 days after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202216 Oct 2025

First posted17 Aug 2022
Study start17 Aug 2022
Primary completion18 Jun 2025
Study completion16 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Male InfertilityStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05503862
Sponsor's protocol ID: STU00216874
Status last verified: Mar 2026
First submitted: 12 Jul 2022
Last updated: 3 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Male Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive
ClinicalTrials.gov ID: NCT05503862
Acronym / sponsor ID: STU00216874
Conditions: Male Infertility
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 17 Aug 2022 (actual)
Primary completion: 18 Jun 2025 (actual)
Study completion: 16 Oct 2025 (actual)
First posted: 17 Aug 2022 (actual)
Results: Posted 3 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Arm A	Experimental	Device: YoSpermAt home semen testing via the YoSperm device
Arm B	No intervention	–Standard of Care

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
YoSpermThe 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.	Device	Arm A

Primary outcome

Number of Participants Who Completed the Home Semen Testing
Time frame: Device mailed to patient immediately following randomization
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Time frame: Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2) after baseline.
Fertility Quality of Life (FertiQoL) Core Score. FertiQoL is a measure of fertility-related quality of life. The total score reported in this study was derived from the Emotional, Mind-Body, Relational, and Social domains. Scores range from 0 to 100, with higher scores indicating better fertility-related quality of life and lower scores indicating worse fertility-related quality of life. Unit of measure: scores on a scale. Subscale and total scoring: Scoring consists of three steps. 1. Reverse items. 2. Calculate raw scores by summing all items that belong to the subscale or total scale. For the Core FertiQoL add all 'Q' items (24 items). For the Treatment FertiQoL add all the 'T' items (10 items). For the Total FertiQoL add all Core and Treatment items (34 items). 3. To compute scaled scores for the subscale and total scales, multiply the relevant raw score by 25/k, where k is the number of items in the subscale. The scaled scores range is 0 to 100.
Change in Fertility-related WHO-5 Questionnaire
Time frame: Original occurred at baseline. Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2)
To assess participant's well-being as it relates to their fertility World Health Organization Five Well-Being Index (WHO-5). The WHO-5 is a 5-item measure of current psychological well-being. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better psychological well-being and lower scores indicating worse psychological well-being. Unit of measure: scores on a scale

8 secondary outcomes

Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Time frame: 60-120 days after baseline
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Time frame: 3 months
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Time frame: 300-425 days
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Time frame: 367 to 967 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1
Time frame: 60-120 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2
Time frame: 60-150 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1
Time frame: 300-425 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2
Time frame: 367 to 967 days after baseline

Results and safety

Results posted to the registry on 3 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	39	22
Arm B	67	34

Primary outcome: Number of Participants Who Completed the Home Semen Testing

Time frame: Device mailed to patient immediately following randomization. Count of participants. Unit: Participants

Measure	Arm A n = 39	Arm B n = 0
Value	39	0

Population analysed: Arm A is comprised of participants in the study who completed the at home semen test. Subjects in arm A were asked to complete an at-home semen test, per the study protocol.

Primary outcome: Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)

Time frame: Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2) after baseline.. Median (Inter-Quartile Range). Unit: FertiQoL Scores

Measure	Arm A n = 39	Arm B n = 67
Baseline - Scaled subscale: Emotional	83.33 (62.5 to 95.83)	75 (50 to 95)
Baseline - Scaled subscale: Mind/body	89.58 (79.17 to 100)	82.50 (66.67 to 95.83)
Baseline - Scaled subsclae: Relational	70.83 (58.33 to 80)	66.67 (50.83 to 79.17)
Baseline - Scaled subscale: Social	79.17 (62.50 to 87.50)	75 (58.33 to 79.17)
Baseline - Total scaled FertiQoL score	82.29 (65.63 to 87.50)	75 (58.54 to 85.42)
Short Term F/U - Definition 1 - Scaled subscale: Emotional	83.33 (66.67 to 95.83)	70.83 (45.83 to 95.83)
Short Term F/U - Definition 1 - Scaled subscale: Mind/Body	87.50 (81.67 to 100.00)	83.33 (50 to 100)
Short Term F/U - Definition 1 - Scaled subscale: Relational	75.00 (50.00 to 83.33)	70.83 (54.17 to 83.33)

Population analysed: of the 106 subjects that completed initial testing, many did not complete the F/U surveys, which is why the numbers of each the outcomes below differs from the total.

Primary outcome: Change in Fertility-related WHO-5 Questionnaire

Time frame: Original occurred at baseline. Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2). Median (Inter-Quartile Range). Unit: WHO 5 Score

Measure	Arm A n = 39	Arm B n = 67
Original Data	64 (52 to 76)	64 (56 to 76)
Short Term F/U - Definition 1: the values collected between 60 - 120 days of the baseline visit.	64 (52 to 76)	64 (40 to 72)
Short Term F/U - Definition 2: the values collected between 60 - 150 days of the baseline visit.	62 (48 to 76)	64 (40 to 72)
Long Term F/U - Definition 1: the first value collected between 300 - 425 days of the baseline visit	64 (42 to 76)	60 (48 to 76)
Long Term F/U - Definition 2: the first value collected after 365 days from the baseline visit	72 (60 to 80)	64 (56 to 72)

Population analysed: of the 106 subjects that completed initial testing, many did not complete the F/U surveys, which is why the numbers of each the outcomes below differs from the total.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	0 of 0	0 of 0	0
Arm B	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Due to the varied methods of recruitment, many enrollees at each stage of the screening, consent, and study process were subsequently found to be untruthful with the study team - either attempting to enroll multiple times using different demographic information but the same mailing address and providing fake mailing addresses - with the presumed goal of receiving payment for participation. There was also low engagement and response to follow-up for those who did participate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Male Infertility

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing YoSperm in people with Male Infertility, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Completed the Home Semen Testing (time frame: Device mailed to patient immediately following randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.