ACTIVE_NOT_RECRUITING

Home Semen Testing in Men Beginning Attempts to Conceive

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-09
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05503862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Natal males over the age of 18 with no prior children who are interested in future fertility
  2. * Current female partner
  3. * Not attempting to conceive for more than 3 months
  4. * Willing to sign the Informed Consent Form
  5. * Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
  6. * Ownership or accessibility of a smart phone or electronic device that is compatible with the YoSperm® device
  7. * Prior semen testing
  8. * History of male infertility, Klinefelter syndrome, undescended testis, or chemotherapy
  9. * Female partner with history of infertility
  10. * Female partner with irregular menstrual periods
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Northwestern University Department of Urology
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-09
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-09-09
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Male Infertility