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Completed

NCT Number: NCT05503862

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.

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Urology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YoSperm

Device

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 outcomes

  1. Was the home semen testing completed- yes/no?

    Time frame: 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.

  2. Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).

    Time frame: 12 months

    To assess participant well-being over the course of the study.

  3. Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.

    Time frame: 12 months

    To evaluate the participant's fertility over the course of the study.

  4. Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)

    Time frame: 12 months

    To assess participant's fertility quality of life over the course of the study.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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