YoSperm for Men Infertility

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwestern University Department of Urology, Chicago, IL
Men Infertility+2 More
YoSperm - Device
Eligibility
18+
Male
What conditions do you have?
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Study 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. 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.

Eligible Conditions

  • Men Infertility

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).
Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
Day 0
Was the home semen testing completed- yes/no?

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm B
1 of 2
Arm A
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: YoSperm · No Placebo Group · N/A

Arm A
Device
Experimental Group · 1 Intervention: YoSperm · Intervention Types: Device
Arm BNoIntervention Group · 1 Intervention: Arm B · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Northwestern University Department of Urology · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2016First Recorded Clinical Trial
1 TrialsResearching Men Infertility
1 CompletedClinical Trials

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,421 Previous Clinical Trials
717,177 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a current female partner.\n
You are able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
You own or have access to a smart phone or electronic device that is compatible with the YoSperm® device.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.