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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. Number of Participants Who Completed the Home Semen Testing

    Time frame: Device mailed to patient immediately following 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 Fertility Quality of Life Questionnaire (FertiQoL)

    Time frame: Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2) after baseline.

    Fertility Quality of Life (FertiQoL) Core Score. FertiQoL is a measure of fertility-related quality of life. The total score reported in this study was derived from the Emotional, Mind-Body, Relational, and Social domains. Scores range from 0 to 100, with higher scores indicating better fertility-related quality of life and lower scores indicating worse fertility-related quality of life. Unit of measure: scores on a scale.

    Subscale and total scoring:

    Scoring consists of three steps.

    • Reverse items.
    • Calculate raw scores by summing all items that belong to the subscale or total scale. For the Core FertiQoL add all 'Q' items (24 items). For the Treatment FertiQoL add all the 'T' items (10 items). For the Total FertiQoL add all Core and Treatment items (34 items).
    • To compute scaled scores for the subscale and total scales, multiply the relevant raw score by 25/k, where k is the number of items in the subscale. The scaled scores range is 0 to 100.

  3. Change in Fertility-related WHO-5 Questionnaire

    Time frame: Original occurred at baseline. Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2)

    To assess participant's well-being as it relates to their fertility

    World Health Organization Five Well-Being Index (WHO-5). The WHO-5 is a 5-item measure of current psychological well-being. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better psychological well-being and lower scores indicating worse psychological well-being. Unit of measure: scores on a scale

Secondary outcomes

  1. Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1

    Time frame: 60-120 days after baseline

    Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire administered approximately 3 months after baseline. The questionnaire assessed pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.

  2. Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)

    Time frame: 3 months

    Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire administered approximately 3 months after baseline. The questionnaire assessed pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.

  3. Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1

    Time frame: 300-425 days

    Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire collected between 300 and 425 days after baseline. Outcomes included pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.

  4. Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2

    Time frame: 367 to 967 days after baseline

    Fertility-related outcomes were assessed using a follow-up Fertility Questionnaire collected from 367 to 967 days after baseline. Outcomes included pregnancy achievement, attempts to conceive, duration of attempts to conceive, fertility evaluation, fertility testing, fertility treatments, fertility diagnoses, and assisted reproductive procedures.

  5. Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1

    Time frame: 60-120 days after baseline

    Continuation of the Fertility Questionnaire

  6. Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2

    Time frame: 60-150 days after baseline

    Continuation of the Fertility Questionnaire

  7. Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1

    Time frame: 300-425 days after baseline

    Continuation of the Fertility Questionnaire

  8. Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2

    Time frame: 367 to 967 days after baseline

    Continuation of the Fertility Questionnaire

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
Sep 3, 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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