Home Semen Testing in Men Beginning Attempts to Conceive

NCT ID: NCT05503862

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

At home semen testing via the YoSperm device

Group Type: EXPERIMENTAL

YoSperm

Intervention Type: 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 B

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

YoSperm

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Halpern

Assistant Professor, Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University Department of Urology

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00216874

Identifier Type: -

Identifier Source: org_study_id