Home Semen Testing in Men Beginning Attempts to Conceive

Northwestern University

Status: Active, not recruiting

Conditions: Male Infertility

Treatments: Device: YoSperm

Study type: Interventional

Funder types: Other

Identifiers

NCT05503862

STU00216874

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Arm A

Experimental group

Description:

At home semen testing via the YoSperm device

Treatment:

Device: YoSperm

Arm B

No Intervention group

Description:

Standard of Care