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Home Semen Testing for Male Infertility
N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking to see if home semen testing is a feasible and useful way to screen for male factor infertility. They will also be looking at the impact that home semen testing has on fertility-related quality of life and whether or not it increases the diagnosis and treatment of male infertility.
Who is the study for?
This trial is for men over 18 without children, who are starting to try for a baby with their female partner. They should not have tried conceiving for more than 3 months and must be able to use smart devices compatible with the YoSperm test. Men with a history of infertility or certain medical conditions, or women with irregular periods or infertility history cannot join.
What is being tested?
The study tests the effectiveness of home semen testing using YoSperm as an early screening tool for male infertility. It aims to see if this method is user-friendly and whether it can reduce anxiety related to fertility while speeding up diagnosis and treatment.
What are the potential side effects?
Since this trial involves home semen testing rather than medication or invasive procedures, there are no direct side effects associated with the intervention being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).
Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
At home semen testing via the YoSperm device
Group II: Arm BActive Control1 Intervention
Standard of Care
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,642 Previous Clinical Trials
957,872 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man over 18 without children but interested in having kids in the future.My female partner has a history of infertility.I currently have a female partner.My female partner has irregular menstrual cycles.I have a history of male infertility, Klinefelter syndrome, undescended testis, or have undergone chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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