A Pilot, Randomized Clinical Trial of Universal Home Semen Analysis Screening for the Evaluation of Male Infertility

Project: Research project

Project Details


Infertility affects 15% of all couples in the United States, and successful diagnosis and treatment costs an average of up to $50,000 per couple. Approximately half of all infertile couples have a male factor etiology, yet male partner evaluation is disproportionately bypassed with an estimated 860,000 male partners not evaluated at the time of fertility consultation. Most couples attempt to conceive for 22.3 months before presentation for male fertility evaluation. This delay in diagnosis and treatment can impair quality of life, treatment outcomes, and increase overall healthcare costs. We previously surveyed 634 men without children and found that among men concerned about infertility, only 29% were likely to discuss these concerns with a health care provider. Moreover, men were more likely to pursue home semen testing versus laboratory-based semen testing (p=0.04). In combination, these findings suggest that the need for a formal provider evaluation and laboratory-based semen analysis are barriers to male fertility evaluation. We have also performed cost-effectiveness analysis demonstrating that a strategy of universal home semen testing can dramatically decrease a couple’s time to evaluation and treatment for infertility. Given our preliminary data, our central hypothesis is that universal home semen testing prior to attempts to conceive is more feasible for patients than conventional semen testing and can lead to early detection of male factor infertility, thereby expediting evaluation and treatment for the couple while minimizing unnecessary cost and morbidity. We propose to investigate our hypothesis with the following specific aims: 1) Conduct a pilot, randomized clinical trial to examine the feasibility and effectiveness of home semen testing for early detection of male infertility; 2) Determine potential barriers to broad-scale implementation of universal home semen testing. Successful completion of the proposed aims will provide the basis for a future, large-scale, randomized trial of home-based screening for male factor infertility with the ultimate goal of increasing access to care and decreasing time to evaluation for subfertile men. The proposed study is the first of its kind to propose universal screening for male factor infertility among couples attempting to conceive, and it has the potential to create a true paradigm shift in the approach to male fertility evaluation and treatment in the United States and beyond.
Effective start/end date3/15/223/14/24


  • American Society for Reproductive Medicine (FE NoA for SP0073181)


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