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.
Trial summary
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. Read more about this study
- 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
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
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 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.
- Reverse items.
- 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).
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Halpern, Northwestern University
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