Home Semen Testing in Men Beginning Attempts to Conceive

NCT05503862 | Completed FDA Device

• 1 other identifier: STU00216874
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  12 months

Study Arms (2)

Arm A

EXPERIMENTAL

At home semen testing via the YoSperm device

Device: YoSperm

Arm B

NO INTERVENTION

Standard of Care

Interventions

YoSperm DEVICE

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.

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Urology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Urology

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 17, 2022
• Study Start: September 9, 2022
• Primary Completion: June 30, 2025
• Study Completion: October 16, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)