Home Semen Testing for Male Infertility

Overseen By Lydia Landrum

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Prior semen testing, Male infertility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect male infertility early using a home semen test. The goal is to make it easier and cheaper for couples beginning to try for a baby to determine if male infertility might be an issue. Participants will either use the YoSperm device (a home sperm test) at home or follow the standard care path. Researchers will evaluate the test's ease of use and its impact on quality of life. Men who have not tried to conceive for more than three months, have a partner, and have not undergone previous semen testing might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could simplify fertility testing for many couples.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this home semen testing is safe for male infertility evaluation?

Research has shown that the YO Sperm Test is safe for home use. The FDA has approved it, confirming it meets safety standards for medical devices. This test allows users to check sperm quality, including sperm count and movement, without visiting a lab. Studies indicate it is over 97% accurate, providing reliable results.

No reports of harm or serious side effects have emerged from using the test, making it a well-tolerated option for men who want to check their fertility at home. For any concerns, consulting a healthcare professional is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods for assessing male infertility, which often require clinic visits and specialized equipment, the YoSperm device offers a convenient at-home semen testing option. This device empowers individuals by providing privacy and ease of use, potentially reducing the stress and discomfort associated with clinical testing. Researchers are excited about this trial because it could make fertility assessment more accessible and less intimidating, encouraging more men to seek evaluation and treatment sooner.

What evidence suggests that the YoSperm device is effective for detecting male infertility?

Research has shown that the YoSperm home testing device, which participants in this trial may use, is highly accurate, with over 97% accuracy in assessing sperm quality. This device measures sperm count and motility, both crucial for male fertility. Studies indicate that the YO test is easy to use and effective as an initial step in evaluating male fertility. By identifying potential issues early, it helps couples address fertility problems sooner, reducing stress and leading to quicker access to treatment if needed. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men over 18 without children, who are starting to try for a baby with their female partner. They should not have tried conceiving for more than 3 months and must be able to use smart devices compatible with the YoSperm test. Men with a history of infertility or certain medical conditions, or women with irregular periods or infertility history cannot join.

Inclusion Criteria

Not attempting to conceive for more than 3 months

Able to read, understand, and complete patient questionnaires, pain texts, and medication diary

Willing to sign the Informed Consent Form

Exclusion Criteria

Prior semen testing

My female partner has a history of infertility.

My female partner has irregular menstrual cycles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the YoSperm device for home semen testing to assess feasibility and utility

12 months

Home-based testing

Follow-up

Participants are monitored for changes in fertility-related quality of life and well-being

12 months

What Are the Treatments Tested in This Trial?

Interventions

• YoSperm

Trial Overview The study tests the effectiveness of home semen testing using YoSperm as an early screening tool for male infertility. It aims to see if this method is user-friendly and whether it can reduce anxiety related to fertility while speeding up diagnosis and treatment.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 1 Intervention

At home semen testing via the YoSperm device

Group II: Arm B Active Control 1 Intervention

Standard of Care

YoSperm is already approved in United States for the following indications:

Approved in United States as Yo Sperm Male Fertility Testing System for:

• Male fertility testing
• Sperm count estimation
• Sperm motility assessment

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The SpermMar test effectively detects sperm antibodies in semen, showing complete correspondence with established tests like the Gelatin Agglutination Test (GAT) and Immunobead tests in a study involving 30 sera samples.

Although the Immunobead test was slightly more sensitive, the SpermMar test is easier to use and assess, making it a recommended option for screening sperm antibodies, albeit currently limited to detecting only IgG antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the SpermMar test with currently accepted procedures for detecting human sperm antibodies. Kay, DJ., Boettcher, B.[2019]

Semen analysis is the primary method for diagnosing male infertility, but it has limitations due to subjective evaluations and variations in sperm concentration and motility caused by various factors.

Recent advancements in computerized systems for semen analysis offer a more objective and rapid assessment, allowing for a better evaluation of sperm motility and the potential use of electron microscopy to identify ultrastructural abnormalities in sperm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of seminal fluid: modern aspects of an old examination]. Quadri, R., Rosa, C., Fonzo, D.[2006]

Home semen analysis devices have been developed to address the discomfort and cost associated with traditional clinic visits for semen analysis, which is crucial for diagnosing male factor infertility.

This review highlights the limitations of current home semen test devices and suggests areas for future improvement, indicating that while these devices offer convenience, they may not yet fully meet clinical standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home testing for male factor infertility: a review of current options. Kobori, Y.[2019]

Semen analysis is a safe, reliable, and cost-effective screening test for assessing male fertility, which can help identify potential issues before attempting conception.

Early detection of low sperm counts through semen analysis allows for timely interventions, such as lifestyle changes or medical treatments, and can lead to improved fertility outcomes, including options like sperm cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why should we screen for male fertility? Madhusoodanan, V., Gonzalez, DC., Jampa, A., et al.[2021]

At-home semen analysis test kits could provide a more comfortable and private option for men facing infertility issues, addressing the embarrassment associated with traditional clinic visits.

The review highlights that while at-home kits offer convenience, they may have limitations in accuracy and reliability compared to conventional lab-based semen analysis methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Update on Home Testing for Male Fertility. Gonzalez, D., Narasimman, M., Best, JC., et al.[2021]

Citations

1. yospermtest.com yospermtest.com/

YO Home Sperm Test A private, easy way to check sperm quality at home with no lab visit or mail-in needed. With over 97% accuracy, YO measures Sperm Concentration, Motility, ...

2. amazon.com amazon.com/YO-Analysis-Concentration-Motility-Progressive/dp/B0DWXGG9M8

YO Home Sperm Test | #1 FDA Cleared Home Semen ... ACCURATE and DOCTOR RECOMMENDED - This FDA Cleared at-home male fertility test reports results with greater than 97% accuracy in clinical trials.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0090429524002577

Amateur vs Professional Users of the YO Home Sperm Test The YO test is user-friendly and can be used as an effective initial home screening tool to gain preliminary insight into the fertility status of the male in a ...

4. yospermtest.com yospermtest.com/pages/what-yo-reports

What YO Reports A private, easy way to check sperm quality at home with no lab visit or mail-in needed. With over 97% accuracy, YO measures Sperm Concentration, Motility, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8443999/

Clinical Update on Home Testing for Male Fertility - PMC At-home semen analysis kits provide a rapid, cost-effective tool for evaluating fertility potential in couples seeking pregnancy that may be affected by male ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K241628.pdf

A 510(k) Number K241628 B Applicant Medi The YO Sperm Test (YO 3.0) is a smartphone-based home test for semen analysis performed by lay users. The parameters reported by the YO Home Sperm Test (YO 3.0) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8051200/

Simplified sperm testing devices: a possible tool to overcome ... Men can use this 'at-home' test to screen their sperm for normozoospermia or oligozoospermia with a reported accuracy of 98% (Table II) (Coppola et al., 2010).

8. mylabbox.com mylabbox.com/product/at-home-male-fertility-test/?srsltid=AfmBOorPqsXLTqkhYCtgIfn0ifiouvogQ80gAHmVFGnp4gp7HI7YJfc_

Male Fertility Test - At-home health & wellness testing YO is an FDA approved home sperm test that allows you to check your sperm quality in the privacy of your home. Including sperm count & motility it is the gold ...