Male Infertility
Conditions
Brief 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.
Interventions
DEVICEYoSperm
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible patients will be randomized to one of two arms: standard of care office-based pathway or the at home semen testing pathway utilizing the FDA, commercially approved YoSperm® device.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed the Home Semen Testing | 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. |
| Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL) | 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. 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. |
| Change in Fertility-related WHO-5 Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1 | 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. |
| Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline) | 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. |
| Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1 | 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. |
| Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2 | 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. |
| Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1 | 60-120 days after baseline | Continuation of the Fertility Questionnaire |
| Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2 | 60-150 days after baseline | Continuation of the Fertility Questionnaire |
| Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1 | 300-425 days after baseline | Continuation of the Fertility Questionnaire |
| Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2 | 367 to 967 days after baseline | Continuation of the Fertility Questionnaire |
Countries
United States
Participant flow
Recruitment details
Patients were recruited through institutional outreach with flyers and partnership with primary care providers, as well as through online platforms including fertility forums, family planning forums, and research recruitment forums. Patients interested in the study underwent an initial screening with a study coordinator prior to randomization.
Pre-assignment details
A total of 283 patients were screened. After excluding patients who did not sign the consent (2), did not complete the baseline survey (20), and those subjects who were not randomized due to other exclusion / eligibility criteria or due to attempting to enroll in the study more than once (90), a total of 171 patients were randomized. However, only 106 patients completed all baseline questionnaires and had valid mailing addresses, thus resulting in the enrolled number.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| Annual Income >$100,000 | 23 Participants |
| Annual Income < $25,000 | 1 Participants |
| Annual Income $25,000-50,000 | 6 Participants |
| Annual Income $50,000-100,000 | 34 Participants |
| Annual Income Unknown | 1 Participants |
| Are you currently trying to get pregnant? No | 63 Participants |
| Are you currently trying to get pregnant? Yes | 43 Participants |
| Do you have any biological children? No | 105 Participants |
| Do you have any biological children? Unknown | 1 Participants |
| Exercise Status 1 - 3 times per week | 29 Participants |
| Exercise Status >3 times per week | 39 Participants |
| Exercise Status Did not respond | 7 Participants |
| Exercise Status Less than once per week | 11 Participants |
| Exercise Status never | 2 Participants |
| Highest Level of Education College graduate (Bachelor's degree) | 47 Participants |
| Highest Level of Education High-school | 2 Participants |
| Highest Level of Education Post-graduate degree | 27 Participants |
| Highest Level of Education Some college | 28 Participants |
| How would you characterize your overall health status? Excellent | 21 Participants |
| How would you characterize your overall health status? Fair | 1 Participants |
| How would you characterize your overall health status? Good | 17 Participants |
| How would you characterize your overall health status? Very good | 42 Participants |
| If no, are you planning to begin attempts to conceive in the next year? Unknown | 16 Participants |
| If no, are you planning to begin attempts to conceive in the next year? Yes | 51 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian | 6 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Black or African American | 17 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Other | 3 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Prefer not to say | 1 Participants |
| Race/Ethnicity, Customized Race and Ethnicity White | 29 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 39 Participants |
| To the best of your knowledge, have you ever gotten a previous partner pregnant? No | 102 Participants |
| To the best of your knowledge, have you ever gotten a previous partner pregnant? Yes | 3 Participants |
| To the best of your knowledge, have you ever gotten your current partner pregnant? No | 36 Participants |
| To the best of your knowledge, have you ever gotten your current partner pregnant? Unknown | 3 Participants |
| To the best of your knowledge, have you ever gotten your current partner pregnant? Yes | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed