Trial Outcomes & Findings for Home Semen Testing in Men Beginning Attempts to Conceive (NCT NCT05503862)
NCT ID: NCT05503862
Last Updated: 2026-09-03
Results Overview
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Device mailed to patient immediately following randomization
Results posted on
2026-09-03
Participant Flow
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.
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.
Participant milestones
| Measure |
Arm A
At home semen testing via the YoSperm device
|
Arm B
Standard of Care
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
67
|
|
Overall Study
COMPLETED
|
22
|
34
|
|
Overall Study
NOT COMPLETED
|
17
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home Semen Testing in Men Beginning Attempts to Conceive
Baseline characteristics by cohort
| Measure |
Arm A
n=39 Participants
At home semen testing via the YoSperm device
|
Arm B
n=67 Participants
Standard of Care
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=136 Participants
|
67 Participants
n=136 Participants
|
106 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=136 Participants
|
67 Participants
n=136 Participants
|
106 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Asian
|
5 Participants
n=136 Participants
|
6 Participants
n=136 Participants
|
11 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Black or African American
|
2 Participants
n=136 Participants
|
17 Participants
n=136 Participants
|
19 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Other
|
3 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Prefer not to say
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · White
|
29 Participants
n=136 Participants
|
39 Participants
n=136 Participants
|
68 Participants
n=272 Participants
|
|
Exercise Status
>3 times per week
|
16 Participants
n=136 Participants
|
23 Participants
n=136 Participants
|
39 Participants
n=272 Participants
|
|
Exercise Status
1 - 3 times per week
|
18 Participants
n=136 Participants
|
29 Participants
n=136 Participants
|
47 Participants
n=272 Participants
|
|
Exercise Status
Did not respond
|
0 Participants
n=136 Participants
|
7 Participants
n=136 Participants
|
7 Participants
n=272 Participants
|
|
Exercise Status
Less than once per week
|
3 Participants
n=136 Participants
|
8 Participants
n=136 Participants
|
11 Participants
n=272 Participants
|
|
Exercise Status
never
|
2 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Highest Level of Education
College graduate (Bachelor's degree)
|
13 Participants
n=136 Participants
|
34 Participants
n=136 Participants
|
47 Participants
n=272 Participants
|
|
Highest Level of Education
High-school
|
2 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
Highest Level of Education
Post-graduate degree
|
11 Participants
n=136 Participants
|
16 Participants
n=136 Participants
|
27 Participants
n=272 Participants
|
|
Highest Level of Education
Some college
|
13 Participants
n=136 Participants
|
15 Participants
n=136 Participants
|
28 Participants
n=272 Participants
|
|
Annual Income
$25,000-50,000
|
6 Participants
n=136 Participants
|
20 Participants
n=136 Participants
|
26 Participants
n=272 Participants
|
|
Annual Income
$50,000-100,000
|
19 Participants
n=136 Participants
|
34 Participants
n=136 Participants
|
53 Participants
n=272 Participants
|
|
Annual Income
< $25,000
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Annual Income
>$100,000
|
12 Participants
n=136 Participants
|
11 Participants
n=136 Participants
|
23 Participants
n=272 Participants
|
|
Annual Income
Unknown
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
How would you characterize your overall health status?
Excellent
|
9 Participants
n=136 Participants
|
12 Participants
n=136 Participants
|
21 Participants
n=272 Participants
|
|
How would you characterize your overall health status?
Fair
|
1 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
|
How would you characterize your overall health status?
Good
|
17 Participants
n=136 Participants
|
23 Participants
n=136 Participants
|
40 Participants
n=272 Participants
|
|
How would you characterize your overall health status?
Very good
|
12 Participants
n=136 Participants
|
30 Participants
n=136 Participants
|
42 Participants
n=272 Participants
|
|
Do you have any biological children?
No
|
39 Participants
n=136 Participants
|
66 Participants
n=136 Participants
|
105 Participants
n=272 Participants
|
|
Do you have any biological children?
Unknown
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
To the best of your knowledge, have you ever gotten a previous partner pregnant?
No
|
38 Participants
n=136 Participants
|
64 Participants
n=136 Participants
|
102 Participants
n=272 Participants
|
|
To the best of your knowledge, have you ever gotten a previous partner pregnant?
Yes
|
1 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
To the best of your knowledge, have you ever gotten your current partner pregnant?
No
|
36 Participants
n=136 Participants
|
65 Participants
n=136 Participants
|
101 Participants
n=272 Participants
|
|
To the best of your knowledge, have you ever gotten your current partner pregnant?
Yes
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
To the best of your knowledge, have you ever gotten your current partner pregnant?
Unknown
|
2 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
|
Are you currently trying to get pregnant?
No
|
24 Participants
n=136 Participants
|
39 Participants
n=136 Participants
|
63 Participants
n=272 Participants
|
|
Are you currently trying to get pregnant?
Yes
|
15 Participants
n=136 Participants
|
28 Participants
n=136 Participants
|
43 Participants
n=272 Participants
|
|
If no, are you planning to begin attempts to conceive in the next year?
Yes
|
29 Participants
n=136 Participants
|
51 Participants
n=136 Participants
|
80 Participants
n=272 Participants
|
|
If no, are you planning to begin attempts to conceive in the next year?
Unknown
|
10 Participants
n=136 Participants
|
16 Participants
n=136 Participants
|
26 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: Device mailed to patient immediately following randomizationPopulation: Arm A is comprised of participants in the study who completed the at home semen test. Subjects in arm A were asked to complete an at-home semen test, per the study protocol.
To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.
Outcome measures
| Measure |
Arm A
n=39 Participants
At home semen testing via the YoSperm device
|
Arm B
Standard of Care
|
|---|---|---|
|
Number of Participants Who Completed the Home Semen Testing
|
39 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.Population: of the 106 subjects that completed initial testing, many did not complete the F/U surveys, which is why the numbers of each the outcomes below differs from the total.
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.
Outcome measures
| Measure |
Arm A
n=39 Participants
At home semen testing via the YoSperm device
|
Arm B
n=67 Participants
Standard of Care
|
|---|---|---|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 1 - Scaled subscale: Emotional
|
83.33 FertiQoL Scores
Interval 66.67 to 95.83
|
70.83 FertiQoL Scores
Interval 45.83 to 95.83
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 1 - Scaled subsclae: Relational
|
79.17 FertiQoL Scores
Interval 75.0 to 91.67
|
75.00 FertiQoL Scores
Interval 66.67 to 83.33
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 2 - Scaled subscale: Relational
|
64.58 FertiQoL Scores
Interval 54.17 to 81.25
|
68.75 FertiQoL Scores
Interval 54.17 to 79.17
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 2 - Scaled subscale: Social
|
79.17 FertiQoL Scores
Interval 60.42 to 87.5
|
75.00 FertiQoL Scores
Interval 56.25 to 83.33
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 2 - Total scaled FertiQoL score
|
76.56 FertiQoL Scores
Interval 60.42 to 87.5
|
74.48 FertiQoL Scores
Interval 58.33 to 84.17
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Baseline - Scaled subscale: Emotional
|
83.33 FertiQoL Scores
Interval 62.5 to 95.83
|
75 FertiQoL Scores
Interval 50.0 to 95.0
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Baseline - Scaled subscale: Mind/body
|
89.58 FertiQoL Scores
Interval 79.17 to 100.0
|
82.50 FertiQoL Scores
Interval 66.67 to 95.83
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Baseline - Scaled subsclae: Relational
|
70.83 FertiQoL Scores
Interval 58.33 to 80.0
|
66.67 FertiQoL Scores
Interval 50.83 to 79.17
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Baseline - Scaled subscale: Social
|
79.17 FertiQoL Scores
Interval 62.5 to 87.5
|
75 FertiQoL Scores
Interval 58.33 to 79.17
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Baseline - Total scaled FertiQoL score
|
82.29 FertiQoL Scores
Interval 65.63 to 87.5
|
75 FertiQoL Scores
Interval 58.54 to 85.42
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 1 - Scaled subscale: Mind/Body
|
87.50 FertiQoL Scores
Interval 81.67 to 100.0
|
83.33 FertiQoL Scores
Interval 50.0 to 100.0
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 1 - Scaled subscale: Relational
|
75.00 FertiQoL Scores
Interval 50.0 to 83.33
|
70.83 FertiQoL Scores
Interval 54.17 to 83.33
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 1 - Scaled subscale: Social
|
75.83 FertiQoL Scores
Interval 62.5 to 83.33
|
66.67 FertiQoL Scores
Interval 45.83 to 83.33
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 1 - Total scaled FertiQoL score
|
82.71 FertiQoL Scores
Interval 63.54 to 90.63
|
73.33 FertiQoL Scores
Interval 46.88 to 87.5
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 2 - Scaled subscale: Emotional
|
83.33 FertiQoL Scores
Interval 66.67 to 95.83
|
70.83 FertiQoL Scores
Interval 47.92 to 92.5
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 2 - Scaled subscale: Mind/body
|
87.50 FertiQoL Scores
Interval 81.67 to 100.0
|
81.25 FertiQoL Scores
Interval 50.0 to 100.0
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 2 - Scaled subsclae: Relational
|
75.00 FertiQoL Scores
Interval 50.0 to 83.33
|
70.83 FertiQoL Scores
Interval 54.17 to 83.33
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 2 - Scaled subscale: Social
|
75.83 FertiQoL Scores
Interval 62.5 to 87.5
|
66.67 FertiQoL Scores
Interval 47.92 to 81.25
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Short Term F/U - Definition 2 - Total scaled FertiQoL score
|
82.71 FertiQoL Scores
Interval 63.54 to 90.63
|
72.60 FertiQoL Scores
Interval 47.92 to 86.98
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 1 - Scaled subscale: Emotional
|
100.00 FertiQoL Scores
Interval 91.67 to 100.0
|
95.83 FertiQoL Scores
Interval 73.33 to 100.0
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 1 - Scaled subscale: Mind/body
|
100.00 FertiQoL Scores
Interval 100.0 to 100.0
|
83.33 FertiQoL Scores
Interval 75.0 to 100.0
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 1 - Scaled subscale: Social
|
87.50 FertiQoL Scores
Interval 75.0 to 95.83
|
75.00 FertiQoL Scores
Interval 54.17 to 79.17
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 1 - Total scaled FertiQoL score
|
93.75 FertiQoL Scores
Interval 81.25 to 94.79
|
84.38 FertiQoL Scores
Interval 65.63 to 89.58
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 2 - Scaled subscale: Emotional
|
85.42 FertiQoL Scores
Interval 62.5 to 93.75
|
70.83 FertiQoL Scores
Interval 54.17 to 89.58
|
|
Change in Fertility-related Fertility Quality of Life Questionnaire (FertiQoL)
Long term F/U - Definition 2 - Scaled subscale: Mind/body
|
79.17 FertiQoL Scores
Interval 68.33 to 100.0
|
75.00 FertiQoL Scores
Interval 58.33 to 91.67
|
PRIMARY outcome
Timeframe: 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)Population: of the 106 subjects that completed initial testing, many did not complete the F/U surveys, which is why the numbers of each the outcomes below differs from the total.
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
Outcome measures
| Measure |
Arm A
n=39 Participants
At home semen testing via the YoSperm device
|
Arm B
n=67 Participants
Standard of Care
|
|---|---|---|
|
Change in Fertility-related WHO-5 Questionnaire
Original Data
|
64 WHO 5 Score
Interval 52.0 to 76.0
|
64 WHO 5 Score
Interval 56.0 to 76.0
|
|
Change in Fertility-related WHO-5 Questionnaire
Short Term F/U - Definition 1: the values collected between 60 - 120 days of the baseline visit.
|
64 WHO 5 Score
Interval 52.0 to 76.0
|
64 WHO 5 Score
Interval 40.0 to 72.0
|
|
Change in Fertility-related WHO-5 Questionnaire
Short Term F/U - Definition 2: the values collected between 60 - 150 days of the baseline visit.
|
62 WHO 5 Score
Interval 48.0 to 76.0
|
64 WHO 5 Score
Interval 40.0 to 72.0
|
|
Change in Fertility-related WHO-5 Questionnaire
Long Term F/U - Definition 1: the first value collected between 300 - 425 days of the baseline visit
|
64 WHO 5 Score
Interval 42.0 to 76.0
|
60 WHO 5 Score
Interval 48.0 to 76.0
|
|
Change in Fertility-related WHO-5 Questionnaire
Long Term F/U - Definition 2: the first value collected after 365 days from the baseline visit
|
72 WHO 5 Score
Interval 60.0 to 80.0
|
64 WHO 5 Score
Interval 56.0 to 72.0
|
SECONDARY outcome
Timeframe: 60-120 days after baselinePopulation: The question titled "how many months have you been trying to become pregnant?" will not add up to the total number of participants in each arm due to the fact that the answers for this question are in the median number of months and have been included in a separate outcome measure. The purpose of listing it here is to show the number of participants for which data is missing. The number entered in the "Yes" category refers to the patients who answered "yes" to Are you trying to become pregnant?"
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.
Outcome measures
| Measure |
Arm A
n=21 Participants
At home semen testing via the YoSperm device
|
Arm B
n=28 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you achieved a pregnancy in the last 12 months? · No
|
20 Participants
|
23 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you achieved a pregnancy in the last 12 months? · Yes
|
1 Participants
|
4 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you achieved a pregnancy in the last 12 months? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you had a semen test since your last survey? · No
|
19 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you seen a doctor regarding male fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any procedure for male fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any blood testing for female fertility? · No
|
18 Participants
|
23 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any blood testing for female fertility? · Yes
|
3 Participants
|
4 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any procedure for female fertility? · No
|
20 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you and your partner undergone intrauterine insemination (IUI)? · Yes
|
1 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Are you trying to become pregnant? · Yes
|
12 Participants
|
16 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Are you trying to become pregnant? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Are you trying to become pregnant? · No
|
9 Participants
|
11 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you had a semen test since your last survey? · Yes
|
2 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you had a semen test since your last survey? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you seen a doctor regarding male fertility? · No
|
19 Participants
|
22 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you seen a doctor regarding male fertility? · Yes
|
2 Participants
|
5 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any blood testing for male fertility? · No
|
21 Participants
|
24 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any blood testing for male fertility? · Yes
|
0 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any blood testing for male fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any medication for male fertility? · No
|
19 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any medication for male fertility? · Yes
|
2 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any medication for male fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any procedure for male fertility? · No
|
20 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you received any procedure for male fertility? · Yes
|
1 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · No
|
21 Participants
|
28 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · No
|
21 Participants
|
28 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · No
|
18 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Yes
|
3 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · No
|
21 Participants
|
26 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Yes
|
0 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=None) · No
|
3 Participants
|
5 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=None) · Yes
|
18 Participants
|
23 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=None) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner seen a doctor regarding female fertility? · No
|
18 Participants
|
19 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner seen a doctor regarding female fertility? · Yes
|
3 Participants
|
8 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner seen a doctor regarding female fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any blood testing for female fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any medication for female fertility? · No
|
19 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any medication for female fertility? · Yes
|
2 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any medication for female fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any procedure for female fertility? · Yes
|
1 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Has your partner received any procedure for female fertility? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you and your partner undergone intrauterine insemination (IUI)? · No
|
20 Participants
|
26 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you and your partner undergone intrauterine insemination (IUI)? · Missing Data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you and your partner undergone in vitro fertilization (IVF)? · No
|
20 Participants
|
24 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you and your partner undergone in vitro fertilization (IVF)? · Yes
|
1 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1
Have you and your partner undergone in vitro fertilization (IVF)? · Missing Data
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The question titled "how many months have you been trying to become pregnant?" will not add up to the total number of participants in each arm due to the fact that the answers for this question are in the median number of months and have been included in a separate outcome measure. The purpose of listing it here is to show the number of participants for which data is missing. The number entered in the "Yes" category refers to the patients who answered "yes" to Are you trying to become pregnant?"
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.
Outcome measures
| Measure |
Arm A
n=22 Participants
At home semen testing via the YoSperm device
|
Arm B
n=29 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Are you trying to become pregnant? · No
|
9 Participants
|
12 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Are you trying to become pregnant? · Yes
|
13 Participants
|
16 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you had a semen test since your last survey? · Yes
|
2 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you had a semen test since your last survey? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any medication for male fertility? · Yes
|
2 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any medication for male fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · No
|
22 Participants
|
29 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Missing data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · No
|
22 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you and your partner undergone in vitro fertilization (IVF)? · No
|
21 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any blood testing for female fertility? · Yes
|
3 Participants
|
5 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any blood testing for female fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any medication for female fertility? · No
|
20 Participants
|
26 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any medication for female fertility? · Yes
|
2 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any medication for female fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any procedure for female fertility? · No
|
21 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any procedure for female fertility? · Yes
|
1 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any procedure for female fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you and your partner undergone intrauterine insemination (IUI)? · No
|
21 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you and your partner undergone intrauterine insemination (IUI)? · Yes
|
1 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you and your partner undergone intrauterine insemination (IUI)? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you and your partner undergone in vitro fertilization (IVF)? · Yes
|
1 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you and your partner undergone in vitro fertilization (IVF)? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you achieved a pregnancy in the last 12 months? · No
|
20 Participants
|
23 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you achieved a pregnancy in the last 12 months? · Yes
|
2 Participants
|
5 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you achieved a pregnancy in the last 12 months? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Are you trying to become pregnant? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you had a semen test since your last survey? · No
|
20 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you seen a doctor regarding male fertility? · No
|
20 Participants
|
22 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you seen a doctor regarding male fertility? · Yes
|
2 Participants
|
6 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you seen a doctor regarding male fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any blood testing for male fertility? · No
|
22 Participants
|
24 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any blood testing for male fertility? · Yes
|
0 Participants
|
4 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any blood testing for male fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any medication for male fertility? · No
|
20 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any procedure for male fertility? · No
|
21 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any procedure for male fertility? · Yes
|
1 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you received any procedure for male fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Missing data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · No
|
22 Participants
|
29 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · No
|
19 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Yes
|
3 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Missing data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Yes
|
0 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Missing data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=None) · No
|
3 Participants
|
6 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=None) · Yes
|
19 Participants
|
23 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Have you been diagnosed with any of the following conditions? (choice=None) · Missing data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner seen a doctor regarding female fertility? · No
|
19 Participants
|
19 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner seen a doctor regarding female fertility? · Yes
|
3 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner seen a doctor regarding female fertility? · Missing data
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)
Has your partner received any blood testing for female fertility? · No
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 300-425 daysFertility-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.
Outcome measures
| Measure |
Arm A
n=7 Participants
At home semen testing via the YoSperm device
|
Arm B
n=10 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you achieved a pregnancy in the last 12 months? · No
|
3 Participants
|
8 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you achieved a pregnancy in the last 12 months? · Yes
|
4 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you achieved a pregnancy in the last 12 months? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any medication for male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Are you trying to become pregnant? · No
|
6 Participants
|
5 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Are you trying to become pregnant? · Yes
|
1 Participants
|
5 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you seen a doctor regarding male fertility? · Yes
|
0 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Are you trying to become pregnant? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you had a semen test since your last survey? · No
|
7 Participants
|
8 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you had a semen test since your last survey? · Yes
|
0 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you had a semen test since your last survey? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you seen a doctor regarding male fertility? · No
|
7 Participants
|
8 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you seen a doctor regarding male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any blood testing for male fertility? · No
|
7 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any blood testing for male fertility? · Yes
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any blood testing for male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any medication for male fertility? · No
|
7 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any medication for male fertility? · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any procedure for male fertility? · No
|
7 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any procedure for male fertility? · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you received any procedure for male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · No
|
7 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · No
|
7 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · No
|
6 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Yes
|
1 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · No
|
6 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Yes
|
1 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=None) · No
|
2 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=None) · Yes
|
5 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you been diagnosed with any of the following conditions? (choice=None) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner seen a doctor regarding female fertility? · No
|
5 Participants
|
8 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner seen a doctor regarding female fertility? · Yes
|
2 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner seen a doctor regarding female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any blood testing for female fertility? · No
|
5 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any blood testing for female fertility? · Yes
|
2 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any blood testing for female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any medication for female fertility? · No
|
6 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any medication for female fertility? · Yes
|
1 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any medication for female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any procedure for female fertility? · No
|
7 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any procedure for female fertility? · Yes
|
0 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Has your partner received any procedure for female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you and your partner undergone intrauterine insemination (IUI)? · No
|
7 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you and your partner undergone intrauterine insemination (IUI)? · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you and your partner undergone intrauterine insemination (IUI)? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you and your partner undergone in vitro fertilization (IVF)? · No
|
7 Participants
|
10 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you and your partner undergone in vitro fertilization (IVF)? · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1
Have you and your partner undergone in vitro fertilization (IVF)? · Missing Data
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 367 to 967 days after baselineFertility-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.
Outcome measures
| Measure |
Arm A
n=17 Participants
At home semen testing via the YoSperm device
|
Arm B
n=28 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you achieved a pregnancy in the last 12 months? · No
|
12 Participants
|
24 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you achieved a pregnancy in the last 12 months? · Yes
|
5 Participants
|
4 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you achieved a pregnancy in the last 12 months? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Are you trying to become pregnant? · No
|
11 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Are you trying to become pregnant? · Yes
|
6 Participants
|
19 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Are you trying to become pregnant? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you had a semen test since your last survey? · No
|
14 Participants
|
21 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you had a semen test since your last survey? · Yes
|
3 Participants
|
7 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you had a semen test since your last survey? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you seen a doctor regarding male fertility? · No
|
13 Participants
|
17 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you seen a doctor regarding male fertility? · Yes
|
4 Participants
|
11 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you seen a doctor regarding male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any blood testing for male fertility? · No
|
12 Participants
|
19 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any blood testing for male fertility? · Yes
|
5 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any blood testing for male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any medication for male fertility? · No
|
14 Participants
|
17 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any medication for male fertility? · Yes
|
3 Participants
|
11 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any medication for male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any procedure for male fertility? · No
|
15 Participants
|
21 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any procedure for male fertility? · Yes
|
2 Participants
|
7 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you received any procedure for male fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · No
|
17 Participants
|
28 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Varicocele) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · No
|
17 Participants
|
28 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Yes
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Azoospermia) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · No
|
13 Participants
|
27 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Yes
|
4 Participants
|
1 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Low testosterone) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · No
|
14 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Yes
|
3 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=Erectile dysfunction) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=None) · No
|
5 Participants
|
4 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=None) · Yes
|
12 Participants
|
24 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you been diagnosed with any of the following conditions? (choice=None) · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner seen a doctor regarding female fertility? · No
|
10 Participants
|
13 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner seen a doctor regarding female fertility? · Yes
|
7 Participants
|
15 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner seen a doctor regarding female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any blood testing for female fertility? · No
|
10 Participants
|
17 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any blood testing for female fertility? · Yes
|
7 Participants
|
11 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any blood testing for female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any medication for female fertility? · No
|
11 Participants
|
19 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any medication for female fertility? · Yes
|
6 Participants
|
9 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any medication for female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any procedure for female fertility? · No
|
14 Participants
|
21 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any procedure for female fertility? · Yes
|
3 Participants
|
7 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Has your partner received any procedure for female fertility? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you and your partner undergone intrauterine insemination (IUI)? · No
|
17 Participants
|
25 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you and your partner undergone intrauterine insemination (IUI)? · Yes
|
0 Participants
|
3 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you and your partner undergone intrauterine insemination (IUI)? · Missing Data
|
0 Participants
|
0 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you and your partner undergone in vitro fertilization (IVF)? · No
|
15 Participants
|
26 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you and your partner undergone in vitro fertilization (IVF)? · Yes
|
2 Participants
|
2 Participants
|
|
Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2
Have you and your partner undergone in vitro fertilization (IVF)? · Missing Data
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60-120 days after baselinePopulation: Continuation of the Fertility Questionnaire
Continuation of the Fertility Questionnaire
Outcome measures
| Measure |
Arm A
n=21 Participants
At home semen testing via the YoSperm device
|
Arm B
n=28 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1
|
5 months
Interval 3.0 to 12.0
|
6 months
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: 60-150 days after baselineContinuation of the Fertility Questionnaire
Outcome measures
| Measure |
Arm A
n=22 Participants
At home semen testing via the YoSperm device
|
Arm B
n=29 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2
|
6 months
Interval 4.0 to 10.0
|
6 months
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: 300-425 days after baselineContinuation of the Fertility Questionnaire
Outcome measures
| Measure |
Arm A
n=7 Participants
At home semen testing via the YoSperm device
|
Arm B
n=10 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1
|
8.5 months
Interval 3.0 to 14.0
|
6 months
Interval 6.0 to 7.5
|
SECONDARY outcome
Timeframe: 367 to 967 days after baselinePopulation: Continuation of the Fertility Questionnaire
Continuation of the Fertility Questionnaire
Outcome measures
| Measure |
Arm A
n=17 Participants
At home semen testing via the YoSperm device
|
Arm B
n=28 Participants
Standard of Care
|
|---|---|---|
|
Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2
|
17 months
Interval 12.0 to 24.0
|
14 months
Interval 6.0 to 24.0
|
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place