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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
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.
Northwestern University Department of Urology
Chicago, Illinois, United States
Number of Participants Who Completed the Home Semen Testing
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Time frame: Device mailed to patient immediately following randomization
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
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. 1. Reverse items. 2. 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). 3. 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.
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.
Change in Fertility-related WHO-5 Questionnaire
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
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)
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
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.
Time frame: 60-120 days after baseline
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 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.
Time frame: 3 months
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
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.
Time frame: 300-425 days
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
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.
Time frame: 367 to 967 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1
Continuation of the Fertility Questionnaire
Time frame: 60-120 days after baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2
Continuation of the Fertility Questionnaire
Time frame: 60-150 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1
Continuation of the Fertility Questionnaire
Time frame: 300-425 days after baseline
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2
Continuation of the Fertility Questionnaire
Time frame: 367 to 967 days after baseline