Clinical trial NCT05503862: Home Semen Testing in Men Beginning Attempts to Conceive
Official title: Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Infertility
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to one of two arms: standard of care office-based pathway or the at home semen testing pathway utilizing the FDA, commercially approved YoSperm® device.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Natal males over the age of 18 with no prior children who are interested in future fertility
* Current female partner
* Not attempting to conceive for more than 3 months
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
* Ownership or accessibility of a smart phone or electronic device that is compatible with the YoSperm® device

Exclusion Criteria

* Prior semen testing
* History of male infertility, Klinefelter syndrome, undescended testis, or chemotherapy
* Female partner with history of infertility
* Female partner with irregular menstrual periods

Primary outcomes:
measure: Was the home semen testing completed- yes/no?
timeFrame: At Day 0 post randomization
measure: Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).
timeFrame: 12 months
measure: Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
timeFrame: 12 months
measure: Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Urology
state: Illinois
Study officials:
References: