Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05503862
Other study ID # STU00216874
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 9, 2022
Est. completion date October 2025

Study information

Verified date January 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2025
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
YoSperm
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.

Locations

Country Name City State
United States Northwestern University Department of Urology Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Was the home semen testing completed- yes/no? To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing. At Day 0 post randomization
Primary Change in fertility-related World Health organization-5 Well-Being Index (WHO-5). To assess participant well-being over the course of the study. 12 months
Primary Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire. To evaluate the participant's fertility over the course of the study. 12 months
Primary Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL) To assess participant's fertility quality of life over the course of the study. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT03307655 - Relationship Between Nitric Oxide (NO) in Follicular Fluid and Sperm Fertilization Ability N/A
Withdrawn NCT02839447 - A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
Completed NCT00975117 - Spermotrend in the Treatment of Male Infertility Phase 3
Completed NCT00756561 - HOP-2A - Intratesticular Hormone Levels N/A
Recruiting NCT04541459 - Validation of New Devices Against Ambient Electromagnetic Radiation Early Phase 1
Completed NCT02889341 - Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility N/A
Not yet recruiting NCT03167008 - Vitamin D Level vs Semen Parameters
Completed NCT02268123 - Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
Completed NCT01232465 - Impact of Sperm DNA Integrity on In Vitro Cycles N/A
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Completed NCT03552081 - Tobacco and Sperm Genome: Effects of Smoking Cessation N/A
Recruiting NCT05200663 - Efficacy Comparison of Tamoxifen and Tamoxifen With Antioxidants on Semen Quality of Male With Idiopathic Infertility Phase 2
Completed NCT02025270 - MSCs For Treatment of Azoospermic Patients Phase 1/Phase 2
Recruiting NCT06147700 - Identifying Molecular Determinants of Infertility in Men (MODIFY)
Recruiting NCT06188936 - Home Semen Analysis Tests as a Screening Tool for Fertility Patients N/A
Recruiting NCT04200118 - Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment
Terminated NCT02605070 - Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia Phase 3
Completed NCT01407432 - Impact of Folates in the Care of the Male Infertility Phase 3
Completed NCT00596739 - A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery N/A
Completed NCT00315029 - Patient-Centered Implementation Trial for Single Embryo Transfer N/A