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

200 Participants Needed

Trial Summary

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.

How is the YoSperm home semen test unique compared to other treatments for male infertility?

The YoSperm home semen test is unique because it allows men to analyze their semen at home, providing a more comfortable and private alternative to traditional clinic-based semen analysis, which many find embarrassing and expensive. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Analysis of seminal fluid: modern aspects of an old examination]. [2006]

2. Australia pubmed.ncbi.nlm.nih.gov

Comparison of the SpermMar test with currently accepted procedures for detecting human sperm antibodies. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

Why should we screen for male fertility? [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical Update on Home Testing for Male Fertility. [2021]