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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Northwestern University Department of Urology
Chicago, Illinois, United States
Was the home semen testing completed- yes/no?
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Time frame: At Day 0 post randomization
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).
To assess participant well-being over the course of the study.
Time frame: 12 months
Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
To evaluate the participant's fertility over the course of the study.
Time frame: 12 months
Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
To assess participant's fertility quality of life over the course of the study.
Time frame: 12 months
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