Home Semen Testing in Men Beginning Attempts to Conceive

Not Applicable

Recruiting

• Conditions: Male Infertility
• Interventions: Device: YoSperm

• Registration Number: NCT05503862
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-17
• Study Start: 2022-09-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-04
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	YoSperm	At home semen testing via the YoSperm device

Primary Outcome Measures

Name	Time	Method
Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.	12 months	To evaluate the participant's fertility over the course of the study.
Was the home semen testing completed- yes/no?	At Day 0 post randomization	To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).	12 months	To assess participant well-being over the course of the study.
Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)	12 months	To assess participant's fertility quality of life over the course of the study.

Trial Locations

Locations (1)

Northwestern University Department of Urology; 🇺🇸 Chicago, Illinois, United States