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Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646291
Recruitment Status : Completed
First Posted : November 27, 2020
Results First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Karina Loyo PhD MBA CCDM, Mosie Baby

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Infertility
Infertility, Female
Infertility, Male
Intervention Device: Insemination with the Mosie Baby Kit
Enrollment 350
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 272 70 8
Completed 272 70 8
Not Completed 0 0 0
Arm/Group Title Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent Total
Hide Arm/Group Description 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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 272 70 8 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 70 participants 8 participants 350 participants
20-24 years old
6
   2.2%
5
   7.1%
0
   0.0%
11
   3.1%
25-29 years old
39
  14.3%
20
  28.6%
1
  12.5%
60
  17.1%
30-34 years old
83
  30.5%
30
  42.9%
2
  25.0%
115
  32.9%
35-39 years old
100
  36.8%
10
  14.3%
3
  37.5%
113
  32.3%
40-45 years old
41
  15.1%
5
   7.1%
1
  12.5%
47
  13.4%
45-50 years old
4
   1.5%
0
   0.0%
0
   0.0%
4
   1.1%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 70 participants 8 participants 350 participants
Female
255
  93.8%
65
  92.9%
8
 100.0%
328
  93.7%
Male
17
   6.3%
0
   0.0%
0
   0.0%
17
   4.9%
Non-binary (female)
0
   0.0%
2
   2.9%
0
   0.0%
2
   0.6%
Transgender (female)
0
   0.0%
2
   2.9%
0
   0.0%
2
   0.6%
Transgender (male)
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.3%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 70 participants 8 participants 350 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
   5.1%
0
   0.0%
0
   0.0%
14
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
   9.2%
11
  15.7%
0
   0.0%
36
  10.3%
White
178
  65.4%
35
  50.0%
5
  62.5%
218
  62.3%
More than one race
16
   5.9%
14
  20.0%
2
  25.0%
32
   9.1%
Unknown or Not Reported
39
  14.3%
10
  14.3%
1
  12.5%
50
  14.3%
[1]
Measure Description: Participants were allowed to select all that applied from the options which include the categories listed plus Hispanic/LatinX. The other category below reports those that selected only Hispanic/LatinX plus other as a category. The Multiple Race reflects all that selected either multiple race or more than one race or ethnicity.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 272 participants 70 participants 8 participants 350 participants
272
 100.0%
70
 100.0%
8
 100.0%
350
 100.0%
Cycles Analyzed  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 70 participants 8 participants 350 participants
1 Cycle
98
  36.0%
39
  55.7%
4
  50.0%
141
  40.3%
2 cycles
88
  32.4%
14
  20.0%
2
  25.0%
104
  29.7%
3 cycles
53
  19.5%
8
  11.4%
0
   0.0%
61
  17.4%
4 cycles
16
   5.9%
4
   5.7%
0
   0.0%
20
   5.7%
5 cycles
13
   4.8%
3
   4.3%
0
   0.0%
16
   4.6%
6 cycles
4
   1.5%
2
   2.9%
2
  25.0%
8
   2.3%
1.Primary Outcome
Title Pregnancy Rate
Hide Description The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
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.
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.

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.

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 Number of Participants Analyzed 350 272 70 8
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Participants Achieving Pregnancy
99
  28.3%
71
  26.1%
24
  34.3%
4
  50.0%
Number of Participants Not Getting Pregnant
251
  71.7%
201
  73.9%
46
  65.7%
4
  50.0%
2.Primary Outcome
Title Cycle in Which Pregnancy Was Reported
Hide Description The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnancies Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
This subgroup represents the women who ended up pregnant as a result of using Mosie.
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.

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.

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 Number of Participants Analyzed 99 71 24 4
Measure Type: Count of Participants
Unit of Measure: Participants
1 cycle resulted in a pregnancy
60
  60.6%
46
  64.8%
12
  50.0%
2
  50.0%
2 cycles resulted in a pregnancy
18
  18.2%
12
  16.9%
5
  20.8%
1
  25.0%
3 cycles resulted in a pregnancy
13
  13.1%
9
  12.7%
4
  16.7%
0
   0.0%
4 cycles resulted in a pregnancy
1
   1.0%
1
   1.4%
0
   0.0%
0
   0.0%
5 cycles resulted in a pregnancy
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6 cycles resulted in a pregnancy
4
   4.0%
2
   2.8%
1
   4.2%
1
  25.0%
6+ cycles resulted in a pregnancy
3
   3.0%
1
   1.4%
2
   8.3%
0
   0.0%
3.Primary Outcome
Title Pregnancy Rate Differences Between Couples With Fertility Issues and Without
Hide Description The study will measure the difference in pregnancy rates of Mosie Baby Kit users with known fertility issues and those without known fertility issues.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 350 272 70 8
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with no fertility issue who got pregnant
69
  19.7%
44
  16.2%
21
  30.0%
4
  50.0%
Participants with no fertility issue who did not get pregnant
134
  38.3%
89
  32.7%
42
  60.0%
3
  37.5%
Participants with a fertility issues who got pregnant
31
   8.9%
27
   9.9%
3
   4.3%
1
  12.5%
Participants with a fertility issues who did not get pregnant
116
  33.1%
112
  41.2%
4
   5.7%
0
   0.0%
4.Secondary Outcome
Title Ease of Use
Hide Description The study will examine the perceived ease of use of the Mosie Kit.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 350 272 70 8
Measure Type: Count of Participants
Unit of Measure: Participants
Easy Process Overall Strongly Disagree
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Disagree
2
   0.6%
0
   0.0%
2
   2.9%
0
   0.0%
Neutral
7
   2.0%
6
   2.2%
1
   1.4%
0
   0.0%
Agree
101
  28.9%
85
  31.3%
14
  20.0%
2
  25.0%
Strongly Agree
240
  68.6%
181
  66.5%
53
  75.7%
6
  75.0%
Intuitive Process Strongly Disagree
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Disagree
13
   3.7%
10
   3.7%
3
   4.3%
0
   0.0%
Neutral
19
   5.4%
18
   6.6%
0
   0.0%
1
  12.5%
Agree
121
  34.6%
100
  36.8%
18
  25.7%
3
  37.5%
Strongly Agree
197
  56.3%
144
  52.9%
49
  70.0%
4
  50.0%
5.Secondary Outcome
Title Ease of Use: Usage Steps
Hide Description 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.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 350 272 70 8
Measure Type: Count of Participants
Unit of Measure: Participants
Easy Sample Collection Very Difficult
3
   0.9%
1
   0.4%
2
   2.9%
0
   0.0%
Difficult
16
   4.6%
15
   5.5%
1
   1.4%
0
   0.0%
Neutral
32
   9.1%
18
   6.6%
11
  15.7%
3
  37.5%
Easy
112
  32.0%
90
  33.1%
21
  30.0%
1
  12.5%
Very Easy
187
  53.4%
148
  54.4%
35
  50.0%
4
  50.0%
Draw up Semen Very Difficult
2
   0.6%
0
   0.0%
2
   2.9%
0
   0.0%
Difficult
7
   2.0%
3
   1.1%
4
   5.7%
0
   0.0%
Neutral
31
   8.9%
23
   8.5%
7
  10.0%
1
  12.5%
Easy
128
  36.6%
104
  38.2%
23
  32.9%
1
  12.5%
Very Easy
182
  52.0%
142
  52.2%
34
  48.6%
6
  75.0%
Insert Syringe Very Difficult
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Difficult
2
   0.6%
1
   0.4%
1
   1.4%
0
   0.0%
Neutral
8
   2.3%
7
   2.6%
0
   0.0%
1
  12.5%
Easy
108
  30.9%
91
  33.5%
16
  22.9%
1
  12.5%
Very Easy
232
  66.3%
173
  63.6%
53
  75.7%
6
  75.0%
Deposit Sperm Very Difficult
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Difficult
10
   2.9%
7
   2.6%
3
   4.3%
0
   0.0%
Neutral
24
   6.9%
20
   7.4%
3
   4.3%
1
  12.5%
Easy
105
  30.0%
87
  32.0%
17
  24.3%
1
  12.5%
Very Easy
211
  60.3%
158
  58.1%
47
  67.1%
6
  75.0%
6.Secondary Outcome
Title Use of the Kit as Intended
Hide Description The study will examine whether the user's used the Mosie Kit as described in the instructions and as intended.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
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.
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.

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.

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 Number of Participants Analyzed 350 272 70 8
Measure Type: Count of Participants
Unit of Measure: Participants
Read instructions
333
  95.1%
258
  94.9%
67
  95.7%
8
 100.0%
Prepared items
333
  95.1%
256
  94.1%
69
  98.6%
8
 100.0%
Washed my hands
324
  92.6%
251
  92.3%
65
  92.9%
8
 100.0%
Tested syringe
305
  87.1%
234
  86.0%
63
  90.0%
8
 100.0%
Partner washed hands
288
  82.3%
225
  82.7%
59
  84.3%
4
  50.0%
7.Secondary Outcome
Title Perceived Safety of Using the Mosie Kit
Hide Description The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
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.
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.

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.

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 Number of Participants Analyzed 350 272 70 8
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly Disgree
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Disagree
1
   0.3%
1
   0.4%
0
   0.0%
0
   0.0%
Neutral
2
   0.6%
2
   0.7%
0
   0.0%
0
   0.0%
Agree
95
  27.1%
80
  29.4%
13
  18.6%
2
  25.0%
Strongly Agree
252
  72.0%
189
  69.5%
57
  81.4%
6
  75.0%
8.Other Pre-specified Outcome
Title Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
Hide Description 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.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Pregnant Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
Reflects only the pregnant 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.

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.

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 Number of Participants Analyzed 99 71 24 4
Measure Type: Count of Participants
Unit of Measure: Participants
Pregnancies to participants with Issues of Female Origin
25
  25.3%
20
  28.2%
3
  12.5%
2
  50.0%
Pregnancies to participants with Issues of Male origin
11
  11.1%
8
  11.3%
3
  12.5%
0
   0.0%
Pregnancies to participants No infertility Issue
59
  59.6%
39
  54.9%
18
  75.0%
2
  50.0%
Pregnancies to participantsBoth Male and Female Infertility Issue
4
   4.0%
4
   5.6%
0
   0.0%
0
   0.0%
9.Other Pre-specified Outcome
Title Comparison of Pregnancy Rate Based on Known Fertility Issue
Hide Description The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue reported.
Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
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Hide Analysis Population Description
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.
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 99 71 24 4
Measure Type: Count of Participants
Unit of Measure: Participants
PCOS
12
  12.1%
8
  11.3%
3
  12.5%
1
  25.0%
Endometriosis Low AMH or low ovarian reserve
4
   4.0%
4
   5.6%
0
   0.0%
0
   0.0%
Vaginismus or vulvodynia
6
   6.1%
6
   8.5%
0
   0.0%
0
   0.0%
Tilted Uterus
4
   4.0%
4
   5.6%
0
   0.0%
0
   0.0%
Low Sperm Count
6
   6.1%
5
   7.0%
1
   4.2%
0
   0.0%
Sperm motility issues
4
   4.0%
4
   5.6%
0
   0.0%
0
   0.0%
Erectile Dysfunction
5
   5.1%
5
   7.0%
0
   0.0%
0
   0.0%
Performance issues or sexual anxiety, or inability to orgasm with partner
14
  14.1%
14
  19.7%
0
   0.0%
0
   0.0%
Unexplained infertility
10
  10.1%
9
  12.7%
0
   0.0%
0
   0.0%
No fertility issues reported
51
  51.5%
32
  45.1%
17
  70.8%
2
  50.0%
10.Other Pre-specified Outcome
Title Insemination Schedule's Impact on Pregnancy
Hide Description

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.

Time Frame Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who ended up pregnant are included in this analysis.
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study.
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.

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.

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 Number of Participants Analyzed 99 71 24 4
Measure Type: Count of Participants
Unit of Measure: Participants
1st cycle : at least 2 inseminations per cycle
52
  52.5%
30
  42.3%
10
  41.7%
2
  50.0%
1st cycle not meeting criteria
47
  47.5%
41
  57.7%
14
  58.3%
2
  50.0%
1st cycle not reporting
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2nd cycles : at least 2 inseminations per cycle
18
  18.2%
13
  18.3%
4
  16.7%
1
  25.0%
2nd cycle not meeting criteria
24
  24.2%
16
  22.5%
6
  25.0%
2
  50.0%
2nd cycle not reporting
57
  57.6%
42
  59.2%
14
  58.3%
1
  25.0%
3rd cycles : at least 2 inseminations per cycle
5
   5.1%
4
   5.6%
1
   4.2%
0
   0.0%
3rd cycle not reporting
83
  83.8%
62
  87.3%
18
  75.0%
3
  75.0%
3rd cycle not meeting criteria
11
  11.1%
5
   7.0%
5
  20.8%
1
  25.0%
4th cycles : at least 2 inseminations per cycle
4
   4.0%
4
   5.6%
0
   0.0%
0
   0.0%
4th cycle not meeting criteria
2
   2.0%
1
   1.4%
0
   0.0%
1
  25.0%
4th cycle not reporting
93
  93.9%
66
  93.0%
24
 100.0%
3
  75.0%
5th cycles : at least 2 inseminations per cycle
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5th cycle not meeting criteria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5th cycle not reporting
99
 100.0%
71
 100.0%
24
 100.0%
4
 100.0%
6th cycles : at least 2 inseminations per cycle
1
   1.0%
0
   0.0%
0
   0.0%
1
  25.0%
6th cycle not meeting criteria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6th cycle not reporting
98
  99.0%
71
 100.0%
24
 100.0%
3
  75.0%
11.Other Pre-specified Outcome
Title Effect of COVID on Family Expansion
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
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 because the focus of this questions is on the impact of COVID without regard for sexual preference.
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.

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.

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 Number of Participants Analyzed 350 272 70 80
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
89
  25.4%
67
  24.6%
22
  31.4%
0
   0.0%
No
261
  74.6%
205
  75.4%
48
  68.6%
8
  10.0%
12.Other Pre-specified Outcome
Title Pregnancy Outcomes During COVID
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnancies Heterosexual Females With a Male Partner Females in LGBTQ Relationships Solo Parent
Hide Arm/Group Description:
This subgroup represents the women who ended up pregnant as a result of using Mosie. The information provided includes all women from all 3 arms because the focus of this questions is on the impact of COVID without regard for sexual preference.
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.

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.

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 Number of Participants Analyzed 99 71 24 8
Measure Type: Count of Participants
Unit of Measure: Participants
Conception: September 2019 Birth: June 2020
1
   1.0%
0
   0.0%
1
   4.2%
0
   0.0%
Conception: October 2019 Birth: July 2020
3
   3.0%
2
   2.8%
1
   4.2%
0
   0.0%
Conception: November 2019 Birth: August 2020
5
   5.1%
2
   2.8%
3
  12.5%
0
   0.0%
Conception: December 2019 Birth: August 2020
4
   4.0%
3
   4.2%
0
   0.0%
1
  12.5%
Conception: January 2020 Birth: September 2021
3
   3.0%
2
   2.8%
1
   4.2%
0
   0.0%
Conception: February 2020 Birth: November 2021
10
  10.1%
5
   7.0%
5
  20.8%
0
   0.0%
Conception: March 2020 Birth: December 2021
7
   7.1%
5
   7.0%
2
   8.3%
0
   0.0%
Conception: April 2020 Birth: Jan 2021
16
  16.2%
12
  16.9%
2
   8.3%
2
  25.0%
Conception: May 2020 Birth: Feb 2021
11
  11.1%
8
  11.3%
3
  12.5%
0
   0.0%
Conception: June 2020 Birth: March 2021
19
  19.2%
14
  19.7%
5
  20.8%
0
   0.0%
Conception: July 2020 Birth: April 2021
17
  17.2%
15
  21.1%
1
   4.2%
1
  12.5%
Conception: August 2020 Birth: May 2021
2
   2.0%
2
   2.8%
0
   0.0%
0
   0.0%
Unknown
1
   1.0%
1
   1.4%
0
   0.0%
0
   0.0%
Time Frame No adverse events were reported specifically for this retrospective study.
Adverse Event Reporting Description Adverse events were not collected for this retrospective study. All-cause mortality was not collected and is not recorded for this study.
 
Arm/Group Title All Participants
Hide Arm/Group Description 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.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karina Loyo, Ph.D., MBA, CCDM
Organization: Mosie Baby (Consultant)
Phone: 512-563-1393
EMail: karina@drkarina.com
Layout table for additonal information
Responsible Party: Karina Loyo PhD MBA CCDM, Mosie Baby
ClinicalTrials.gov Identifier: NCT04646291    
Other Study ID Numbers: Mosie-001
First Submitted: August 13, 2020
First Posted: November 27, 2020
Results First Submitted: January 12, 2021
Results First Posted: June 24, 2021
Last Update Posted: June 24, 2021