Home Semen Testing in Men Beginning Attempts to Conceive
Primary Purpose
Male Infertility
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YoSperm
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility
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
Sites / Locations
- Northwestern University Department of UrologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A
Arm B
Arm Description
At home semen testing via the YoSperm device
Standard of Care
Outcomes
Primary Outcome Measures
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.
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).
To assess participant well-being over the course of the study.
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.
Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
To assess participant's fertility quality of life over the course of the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05503862
Brief Title
Home Semen Testing in Men Beginning Attempts to Conceive
Official Title
Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
At home semen testing via the YoSperm device
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
YoSperm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Was the home semen testing completed- yes/no?
Description
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Time Frame
At Day 0 post randomization
Title
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).
Description
To assess participant well-being over the course of the study.
Time Frame
12 months
Title
Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
Description
To evaluate the participant's fertility over the course of the study.
Time Frame
12 months
Title
Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Description
To assess participant's fertility quality of life over the course of the study.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwestern University Department of Urology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydia Landrum
Phone
312-694-9001
Email
Lydia.Landrum@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home Semen Testing in Men Beginning Attempts to Conceive
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