Home Semen Testing in Men Beginning Attempts to Conceive

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

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 Overview

• Status: Recruiting
• Conditions: Male Infertility
• Intervention / Treatment: Device: YoSperm

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Department of Urology
      • Contact: Lydia Landrum; Phone Number: 312-694-9001; Email: Lydia.Landrum@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; At home semen testing via the YoSperm device	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.
No Intervention: Arm B; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: STU00216874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No