Home Semen Testing in Men Beginning Attempts to Conceive

August 13, 2026 updated by: Joshua Halpern, Northwestern University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

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 Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Urology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
At home semen testing via the YoSperm device
Device: YoSperm
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.
No Intervention: Arm B
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Device mailed to patient immediately following randomization
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.
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Time Frame: 60-120 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.
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-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.
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-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.
300-425 days
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Time Frame: 367 to 967 days after baseline
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.
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
Continuation of the Fertility Questionnaire
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
Continuation of the Fertility Questionnaire
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
Continuation of the Fertility Questionnaire
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
Continuation of the Fertility Questionnaire
367 to 967 days after baseline

Collaborators and Investigators

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

Sponsor

Northwestern University

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)

August 17, 2022

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

October 16, 2025

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00216874

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

Yes

product manufactured in and exported from the U.S.

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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