Trial Outcomes & Findings for Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit (NCT NCT04646291)
NCT ID: NCT04646291
Last Updated: 2021-06-24
Results Overview
The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy.
Recruitment status
COMPLETED
Target enrollment
350 participants
Primary outcome timeframe
Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Results posted on
2021-06-24
Participant Flow
A retrospective study of people who had purchased the Mosie Kit between October 2019 and July 2020 was conducted to understand the efficacy, safety and usability of the at-home insemination kit. Participants were recruited in August 2020 via emailed invitation.
Subjects who were 18 years old and who had used the at-home Mosie Insemination kit for at least one cycle were included in the study.
Participant milestones
| Measure |
Heterosexual Females With a Male Partner
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
272
|
70
|
8
|
|
Overall Study
COMPLETED
|
272
|
70
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
Baseline characteristics by cohort
| Measure |
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
20-24 years old
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Customized
25-29 years old
|
39 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Customized
30-34 years old
|
83 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Age, Customized
35-39 years old
|
100 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Customized
40-45 years old
|
41 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Customized
45-50 years old
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
255 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
328 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
17 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non-binary (female)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender (female)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender (male)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
272 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
|
Cycles Analyzed
1 Cycle
|
98 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Cycles Analyzed
2 cycles
|
88 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Cycles Analyzed
3 cycles
|
53 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Cycles Analyzed
4 cycles
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Cycles Analyzed
5 cycles
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Cycles Analyzed
6 cycles
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Pregnancy Rate
Number of Participants Achieving Pregnancy
|
99 Participants
|
71 Participants
|
24 Participants
|
4 Participants
|
|
Pregnancy Rate
Number of Participants Not Getting Pregnant
|
251 Participants
|
201 Participants
|
46 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test.
Outcome measures
| Measure |
All Participants
n=99 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=71 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=24 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=4 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Cycle in Which Pregnancy Was Reported
1 cycle resulted in a pregnancy
|
60 Participants
|
46 Participants
|
12 Participants
|
2 Participants
|
|
Cycle in Which Pregnancy Was Reported
2 cycles resulted in a pregnancy
|
18 Participants
|
12 Participants
|
5 Participants
|
1 Participants
|
|
Cycle in Which Pregnancy Was Reported
3 cycles resulted in a pregnancy
|
13 Participants
|
9 Participants
|
4 Participants
|
0 Participants
|
|
Cycle in Which Pregnancy Was Reported
4 cycles resulted in a pregnancy
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cycle in Which Pregnancy Was Reported
5 cycles resulted in a pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cycle in Which Pregnancy Was Reported
6 cycles resulted in a pregnancy
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Cycle in Which Pregnancy Was Reported
6+ cycles resulted in a pregnancy
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.Population: The number differs because the denominator shows the number of women fitting each of the described criteria. This adjustment is required in order to be able to examine this hypothesis which is based on the rate of each group's pregnancy rate.
The study will measure the difference in pregnancy rates of Mosie Baby Kit users with known fertility issues and those without known fertility issues.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Pregnancy Rate Differences Between Couples With Fertility Issues and Without
Participants with no fertility issue who got pregnant
|
69 Participants
|
44 Participants
|
21 Participants
|
4 Participants
|
|
Pregnancy Rate Differences Between Couples With Fertility Issues and Without
Participants with no fertility issue who did not get pregnant
|
134 Participants
|
89 Participants
|
42 Participants
|
3 Participants
|
|
Pregnancy Rate Differences Between Couples With Fertility Issues and Without
Participants with a fertility issues who got pregnant
|
31 Participants
|
27 Participants
|
3 Participants
|
1 Participants
|
|
Pregnancy Rate Differences Between Couples With Fertility Issues and Without
Participants with a fertility issues who did not get pregnant
|
116 Participants
|
112 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The study will examine the perceived ease of use of the Mosie Kit.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Ease of Use
Intuitive Process · Disagree
|
13 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
|
Ease of Use
Easy Process Overall · Strongly Disagree
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ease of Use
Easy Process Overall · Disagree
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Ease of Use
Easy Process Overall · Neutral
|
7 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Ease of Use
Easy Process Overall · Agree
|
101 Participants
|
85 Participants
|
14 Participants
|
2 Participants
|
|
Ease of Use
Easy Process Overall · Strongly Agree
|
240 Participants
|
181 Participants
|
53 Participants
|
6 Participants
|
|
Ease of Use
Intuitive Process · Strongly Disagree
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ease of Use
Intuitive Process · Neutral
|
19 Participants
|
18 Participants
|
0 Participants
|
1 Participants
|
|
Ease of Use
Intuitive Process · Agree
|
121 Participants
|
100 Participants
|
18 Participants
|
3 Participants
|
|
Ease of Use
Intuitive Process · Strongly Agree
|
197 Participants
|
144 Participants
|
49 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The use of the Mosie Kit requires several steps. In order to examine ease of use, each step was also examined individually. This table reports the data associated with each of use during each step of the insemination process.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Ease of Use: Usage Steps
Easy Sample Collection · Very Difficult
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Easy Sample Collection · Difficult
|
16 Participants
|
15 Participants
|
1 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Easy Sample Collection · Neutral
|
32 Participants
|
18 Participants
|
11 Participants
|
3 Participants
|
|
Ease of Use: Usage Steps
Easy Sample Collection · Easy
|
112 Participants
|
90 Participants
|
21 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Easy Sample Collection · Very Easy
|
187 Participants
|
148 Participants
|
35 Participants
|
4 Participants
|
|
Ease of Use: Usage Steps
Draw up Semen · Very Difficult
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Draw up Semen · Difficult
|
7 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Draw up Semen · Neutral
|
31 Participants
|
23 Participants
|
7 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Draw up Semen · Easy
|
128 Participants
|
104 Participants
|
23 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Draw up Semen · Very Easy
|
182 Participants
|
142 Participants
|
34 Participants
|
6 Participants
|
|
Ease of Use: Usage Steps
Insert Syringe · Very Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Insert Syringe · Difficult
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Insert Syringe · Neutral
|
8 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Insert Syringe · Easy
|
108 Participants
|
91 Participants
|
16 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Insert Syringe · Very Easy
|
232 Participants
|
173 Participants
|
53 Participants
|
6 Participants
|
|
Ease of Use: Usage Steps
Deposit Sperm · Very Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Deposit Sperm · Difficult
|
10 Participants
|
7 Participants
|
3 Participants
|
0 Participants
|
|
Ease of Use: Usage Steps
Deposit Sperm · Neutral
|
24 Participants
|
20 Participants
|
3 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Deposit Sperm · Easy
|
105 Participants
|
87 Participants
|
17 Participants
|
1 Participants
|
|
Ease of Use: Usage Steps
Deposit Sperm · Very Easy
|
211 Participants
|
158 Participants
|
47 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The study will examine whether the user's used the Mosie Kit as described in the instructions and as intended.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Use of the Kit as Intended
Read instructions
|
333 Participants
|
258 Participants
|
67 Participants
|
8 Participants
|
|
Use of the Kit as Intended
Prepared items
|
333 Participants
|
256 Participants
|
69 Participants
|
8 Participants
|
|
Use of the Kit as Intended
Washed my hands
|
324 Participants
|
251 Participants
|
65 Participants
|
8 Participants
|
|
Use of the Kit as Intended
Tested syringe
|
305 Participants
|
234 Participants
|
63 Participants
|
8 Participants
|
|
Use of the Kit as Intended
Partner washed hands
|
288 Participants
|
225 Participants
|
59 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Perceived Safety of Using the Mosie Kit
Strongly Disgree
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Perceived Safety of Using the Mosie Kit
Disagree
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Perceived Safety of Using the Mosie Kit
Neutral
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Perceived Safety of Using the Mosie Kit
Agree
|
95 Participants
|
80 Participants
|
13 Participants
|
2 Participants
|
|
Perceived Safety of Using the Mosie Kit
Strongly Agree
|
252 Participants
|
189 Participants
|
57 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.The study will examine the resulting pregnancy rates of users self-identified as having a male infertility issue versus those having a female infertility issue and those having no reported fertility issue.
Outcome measures
| Measure |
All Participants
n=99 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=71 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=24 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=4 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
Pregnancies to participants with Issues of Male origin
|
11 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
|
Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
Pregnancies to participants No infertility Issue
|
59 Participants
|
39 Participants
|
18 Participants
|
2 Participants
|
|
Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
Pregnancies to participantsBoth Male and Female Infertility Issue
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
Pregnancies to participants with Issues of Female Origin
|
25 Participants
|
20 Participants
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.Population: All participants reporting a pregnancy were asked to indicate as many sources of infertility as desired by marking the options provided. Some participants reported multiple sources for their fertility issue (n=48). Also some participants noted 'No' fertility issue (n=51). The outcome data table shows all conditions available for selection plus a row to capture the participants that indicated no infertility source. Data can only be aggregated across a row; data should not be aggregated by column.
The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue reported.
Outcome measures
| Measure |
All Participants
n=99 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=71 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=24 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=4 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Erectile Dysfunction
|
5 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
PCOS
|
12 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Endometriosis Low AMH or low ovarian reserve
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Vaginismus or vulvodynia
|
6 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Tilted Uterus
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Low Sperm Count
|
6 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Sperm motility issues
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Performance issues or sexual anxiety, or inability to orgasm with partner
|
14 Participants
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
Unexplained infertility
|
10 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Comparison of Pregnancy Rate Based on Known Fertility Issue
No fertility issues reported
|
51 Participants
|
32 Participants
|
17 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.Population: Only participants who ended up pregnant are included in this analysis.
The study examined pregnancy rates of users inseminating twice as expected as compared to using a different schedule. Four time points within each cycle were examined: 24-48 hours before ovulation, within 24 hours of ovulation, 24-48 hours after ovulation and 48 or more hours after ovulation. The recommended time frame is at least 2 insemination during the aggregate of 24-48 hours prior to ovulation and the within 24 hours of ovulation. The table below shows the data for how many women met the insemination criteria for each cycle that reported being pregnant. Note: Number of cycles reported by women vary from 1 cycle to 6 cycles. it is possible that a participant may have met the criteria at one cycle and not the other. Given this, the 3 arms when aggregated per row will equal the total of all participants. However, columns will not add up to the total participants per arm.
Outcome measures
| Measure |
All Participants
n=99 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=71 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=24 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=4 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Insemination Schedule's Impact on Pregnancy
1st cycle : at least 2 inseminations per cycle
|
52 Participants
|
30 Participants
|
10 Participants
|
2 Participants
|
|
Insemination Schedule's Impact on Pregnancy
1st cycle not meeting criteria
|
47 Participants
|
41 Participants
|
14 Participants
|
2 Participants
|
|
Insemination Schedule's Impact on Pregnancy
1st cycle not reporting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Insemination Schedule's Impact on Pregnancy
2nd cycles : at least 2 inseminations per cycle
|
18 Participants
|
13 Participants
|
4 Participants
|
1 Participants
|
|
Insemination Schedule's Impact on Pregnancy
2nd cycle not meeting criteria
|
24 Participants
|
16 Participants
|
6 Participants
|
2 Participants
|
|
Insemination Schedule's Impact on Pregnancy
2nd cycle not reporting
|
57 Participants
|
42 Participants
|
14 Participants
|
1 Participants
|
|
Insemination Schedule's Impact on Pregnancy
3rd cycles : at least 2 inseminations per cycle
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Insemination Schedule's Impact on Pregnancy
3rd cycle not reporting
|
83 Participants
|
62 Participants
|
18 Participants
|
3 Participants
|
|
Insemination Schedule's Impact on Pregnancy
3rd cycle not meeting criteria
|
11 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Insemination Schedule's Impact on Pregnancy
4th cycles : at least 2 inseminations per cycle
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Insemination Schedule's Impact on Pregnancy
4th cycle not meeting criteria
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Insemination Schedule's Impact on Pregnancy
4th cycle not reporting
|
93 Participants
|
66 Participants
|
24 Participants
|
3 Participants
|
|
Insemination Schedule's Impact on Pregnancy
5th cycles : at least 2 inseminations per cycle
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Insemination Schedule's Impact on Pregnancy
5th cycle not meeting criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Insemination Schedule's Impact on Pregnancy
5th cycle not reporting
|
99 Participants
|
71 Participants
|
24 Participants
|
4 Participants
|
|
Insemination Schedule's Impact on Pregnancy
6th cycles : at least 2 inseminations per cycle
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Insemination Schedule's Impact on Pregnancy
6th cycle not meeting criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Insemination Schedule's Impact on Pregnancy
6th cycle not reporting
|
98 Participants
|
71 Participants
|
24 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pregnancies reported as conceived using the Mosie Kit during the months of December 2019 to February 2020 (Pre-COVID) will be compared to those reported for March - July 2020 (during COVID).The study will examine the effect of COVID on family expansion plans. The analysis will be provided in aggregate because the focus is on the impact of COVID on family expansion overall and not on whether one arm has more or less impact. This is a tertiary exploratory measure that does not evaluate the core product.
Outcome measures
| Measure |
All Participants
n=350 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=272 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=70 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=80 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Effect of COVID on Family Expansion
Yes
|
89 Participants
|
67 Participants
|
22 Participants
|
0 Participants
|
|
Effect of COVID on Family Expansion
No
|
261 Participants
|
205 Participants
|
48 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pregnancies reported as conceived using the Mosie Kit during the months of September 2019 to February 2020 (Pre-COVID) will be compared to those reported for March - August 2020 (during COVID).The study will examine whether there were more or less pregnancy rates during COVID. This measure will be an aggregate measure of all women. It is an exploratory measure to understand the impact of COVID. No data will be provided by study arm.
Outcome measures
| Measure |
All Participants
n=99 Participants
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
|
Heterosexual Females With a Male Partner
n=71 Participants
This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Females in LGBTQ Relationships
n=24 Participants
This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
Solo Parent
n=8 Participants
This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.
Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
|
|---|---|---|---|---|
|
Pregnancy Outcomes During COVID
Conception: September 2019 Birth: June 2020
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: October 2019 Birth: July 2020
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: November 2019 Birth: August 2020
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: December 2019 Birth: August 2020
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Pregnancy Outcomes During COVID
Conception: January 2020 Birth: September 2021
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: February 2020 Birth: November 2021
|
10 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: March 2020 Birth: December 2021
|
7 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: April 2020 Birth: Jan 2021
|
16 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
|
Pregnancy Outcomes During COVID
Conception: May 2020 Birth: Feb 2021
|
11 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: June 2020 Birth: March 2021
|
19 Participants
|
14 Participants
|
5 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Conception: July 2020 Birth: April 2021
|
17 Participants
|
15 Participants
|
1 Participants
|
1 Participants
|
|
Pregnancy Outcomes During COVID
Conception: August 2020 Birth: May 2021
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Pregnancy Outcomes During COVID
Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
All Participants
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
Restriction type: LTE60