Home Semen Testing in Men Beginning Attempts to Conceive

Male Infertility Clinical Trial

Official title:

Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503862
• Other study ID #: STU00216874
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Department of Urology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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