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

• Sponsor: Mosie Baby (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04646291
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Actual Duration (Days): 27
• Patients Per Site Per Month: 394.6

Study Details

Study Description

Brief Summary

This study examines the experience of people who have selected to use the at-home insemination Mosie Kit to understand the user's experience, the perceived safety and the efficiency. People who have recently purchased and voluntarily selected to use the Mosie Kit will be invited to complete a one-time online anonymous survey. The results of the survey will be analyzed to understand their experiences.

Condition or Disease	Intervention/Treatment	Phase
Infertility; Infertility, Female; Infertility, Male	Device: Insemination with the Mosie Baby Kit

Detailed Description

At-home intracervical insemination (ICI), folklorickly known as the "turkey-baster" method, has been used for decades to increase likelihood of pregnancy. This method works by depositing semen close to or at the cervix. While there are several devices such as over the counter syringes and silicone caps, the creator of the Mosie Baby syringe believes it is designed to be more ergonomic and compatible with a woman's body, easy and safe to use, and results in depositing the semen at or near the cervix opening. The Mosie Kit provides people with an at-home intracervical insemination option which could be used before resorting to more invasive and expensive options such as Intrauterine Insemination (IUI) or in vitro fertilization. There is vast evidence of Mosie's success in the form of happy users who have conceived. There is a desire to learn more about the safety, useability and experience of using the Mosie kit.

This retrospective study will examine the experience of people who have voluntarily chosen to purchase and use the Mosie Kit. The Mosie Kit consists of 2 syringes and a semen collection cup Understanding the safety, useability and experience of using the Mosie Kit will provide additional information about the nature of using intracervical insemination as a viable method for getting pregnant. The information gained will increase understanding of how viable the Mosie Kit is as a first step in trying to conceive and how it is perceived by the people who have chosen to use it.

Study Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
• Actual Study Start Date: Aug 5, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	Device: 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.	Device: 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.	Device: Insemination with the Mosie Baby Kit; The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.

Outcome Measures

Primary Outcome Measures

1. Pregnancy Rate [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.

2. Cycle in Which Pregnancy Was Reported [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.

3. Pregnancy Rate Differences Between Couples With Fertility Issues and Without [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 the difference in pregnancy rates of Mosie Baby Kit users with known fertility issues and those without known fertility issues.

Secondary Outcome Measures

1. Ease of Use [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.

2. Ease of Use: Usage Steps [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.

3. Use of the Kit as Intended [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.

4. Perceived Safety of Using the Mosie Kit [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.

Other Outcome Measures

1. Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status [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.

2. Comparison of Pregnancy Rate Based on Known Fertility Issue [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 in comparison to the type of infertility issue reported.

3. Insemination Schedule's Impact on Pregnancy [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 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.

4. Effect of COVID on Family Expansion [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.

5. Pregnancy Outcomes During COVID [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Provide implicit consent by filling out and submitting the survey.

• Used a Mosie Kit to conceive during at least one cycle.

• At least 18 years old.

• Has an active email on file (presumed or they would not have received an invitation to participate. This information will not be verified as there is a desire to keep the survey completely anonymous.)

Exclusion Criteria:

• Never used a Mosie Kit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virtual Study - Online Data Collection	Austin	Texas	United States	78704

Sponsors and Collaborators

• Mosie Baby

Investigators

• Principal Investigator: Karina Loyo, PhD MBA CCDM, Independent Researcher

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 31, 2020

More Information

Publications

None provided.

• Responsible Party: Karina Loyo PhD MBA CCDM, Research Consultant, Mosie Baby
• ClinicalTrials.gov Identifier: NCT04646291
• Other Study ID Numbers: Mosie-001
• First Posted: Nov 27, 2020
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Karina Loyo PhD MBA CCDM, Research Consultant, Mosie Baby: Insemination; Infertility; Pregnancy
• Additional relevant MeSH terms: Infertility; Infertility, Female; Infertility, Male

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent	Total
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 Participants	272	70	8	350
Age, Customized (Count of Participants)
20-24 years old	6 2.2%	5 7.1%	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%	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%	4 1.1%
Sex/Gender, Customized (Count of Participants)
Female	255 93.8%	65 92.9%	8 100%	328 93.7%
Male	17 6.3%	0 0%	0 0%	17 4.9%
Non-binary (female)	0 0%	2 2.9%	0 0%	2 0.6%
Transgender (female)	0 0%	2 2.9%	0 0%	2 0.6%
Transgender (male)	0 0%	1 1.4%	0 0%	1 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	14 5.1%	0 0%	0 0%	14 4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	25 9.2%	11 15.7%	0 0%	36 10.3%
White	178 65.4%	35 50%	5 62.5%	218 62.3%
More than one race	16 5.9%	14 20%	2 25%	32 9.1%
Unknown or Not Reported	39 14.3%	10 14.3%	1 12.5%	50 14.3%
Region of Enrollment (Count of Participants)
United States	272 100%	70 100%	8 100%	350 100%
Cycles Analyzed (Count of Participants)
1 Cycle	98 36%	39 55.7%	4 50%	141 40.3%
2 cycles	88 32.4%	14 20%	2 25%	104 29.7%
3 cycles	53 19.5%	8 11.4%	0 0%	61 17.4%
4 cycles	16 5.9%	4 5.7%	0 0%	20 5.7%
5 cycles	13 4.8%	3 4.3%	0 0%	16 4.6%
6 cycles	4 1.5%	2 2.9%	2 25%	8 2.3%

Outcome Measures

1. Primary Outcome

Title	Pregnancy Rate
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	350	272	70	8
Number of Participants Achieving Pregnancy	99 36.4%	71 101.4%	24 300%	4 1.1%
Number of Participants Not Getting Pregnant	251 92.3%	201 287.1%	46 575%	4 1.1%

2. Primary Outcome

Title	Cycle in Which Pregnancy Was Reported
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregnancies	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	99	71	24	4
1 cycle resulted in a pregnancy	60 22.1%	46 65.7%	12 150%	2 0.6%
2 cycles resulted in a pregnancy	18 6.6%	12 17.1%	5 62.5%	1 0.3%
3 cycles resulted in a pregnancy	13 4.8%	9 12.9%	4 50%	0 0%
4 cycles resulted in a pregnancy	1 0.4%	1 1.4%	0 0%	0 0%
5 cycles resulted in a pregnancy	0 0%	0 0%	0 0%	0 0%
6 cycles resulted in a pregnancy	4 1.5%	2 2.9%	1 12.5%	1 0.3%
6+ cycles resulted in a pregnancy	3 1.1%	1 1.4%	2 25%	0 0%

3. Primary Outcome

Title	Pregnancy Rate Differences Between Couples With Fertility Issues and Without
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.

Outcome Measure Data

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
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.
Measure Participants	350	272	70	8
Participants with no fertility issue who got pregnant	69 25.4%	44 62.9%	21 262.5%	4 1.1%
Participants with no fertility issue who did not get pregnant	134 49.3%	89 127.1%	42 525%	3 0.9%
Participants with a fertility issues who got pregnant	31 11.4%	27 38.6%	3 37.5%	1 0.3%
Participants with a fertility issues who did not get pregnant	116 42.6%	112 160%	4 50%	0 0%

4. Secondary Outcome

Title	Ease of Use
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	350	272	70	8
Strongly Disagree	0 0%	0 0%	0 0%	0 0%
Disagree	2 0.7%	0 0%	2 25%	0 0%
Neutral	7 2.6%	6 8.6%	1 12.5%	0 0%
Agree	101 37.1%	85 121.4%	14 175%	2 0.6%
Strongly Agree	240 88.2%	181 258.6%	53 662.5%	6 1.7%
Strongly Disagree	0 0%	0 0%	0 0%	0 0%
Disagree	13 4.8%	10 14.3%	3 37.5%	0 0%
Neutral	19 7%	18 25.7%	0 0%	1 0.3%
Agree	121 44.5%	100 142.9%	18 225%	3 0.9%
Strongly Agree	197 72.4%	144 205.7%	49 612.5%	4 1.1%

5. Secondary Outcome

Title	Ease of Use: Usage Steps
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	350	272	70	8
Very Difficult	3 1.1%	1 1.4%	2 25%	0 0%
Difficult	16 5.9%	15 21.4%	1 12.5%	0 0%
Neutral	32 11.8%	18 25.7%	11 137.5%	3 0.9%
Easy	112 41.2%	90 128.6%	21 262.5%	1 0.3%
Very Easy	187 68.8%	148 211.4%	35 437.5%	4 1.1%
Very Difficult	2 0.7%	0 0%	2 25%	0 0%
Difficult	7 2.6%	3 4.3%	4 50%	0 0%
Neutral	31 11.4%	23 32.9%	7 87.5%	1 0.3%
Easy	128 47.1%	104 148.6%	23 287.5%	1 0.3%
Very Easy	182 66.9%	142 202.9%	34 425%	6 1.7%
Very Difficult	0 0%	0 0%	0 0%	0 0%
Difficult	2 0.7%	1 1.4%	1 12.5%	0 0%
Neutral	8 2.9%	7 10%	0 0%	1 0.3%
Easy	108 39.7%	91 130%	16 200%	1 0.3%
Very Easy	232 85.3%	173 247.1%	53 662.5%	6 1.7%
Very Difficult	0 0%	0 0%	0 0%	0 0%
Difficult	10 3.7%	7 10%	3 37.5%	0 0%
Neutral	24 8.8%	20 28.6%	3 37.5%	1 0.3%
Easy	105 38.6%	87 124.3%	17 212.5%	1 0.3%
Very Easy	211 77.6%	158 225.7%	47 587.5%	6 1.7%

6. Secondary Outcome

Title	Use of the Kit as Intended
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	350	272	70	8
Read instructions	333 122.4%	258 368.6%	67 837.5%	8 2.3%
Prepared items	333 122.4%	256 365.7%	69 862.5%	8 2.3%
Washed my hands	324 119.1%	251 358.6%	65 812.5%	8 2.3%
Tested syringe	305 112.1%	234 334.3%	63 787.5%	8 2.3%
Partner washed hands	288 105.9%	225 321.4%	59 737.5%	4 1.1%

7. Secondary Outcome

Title	Perceived Safety of Using the Mosie Kit
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	350	272	70	8
Strongly Disgree	0 0%	0 0%	0 0%	0 0%
Disagree	1 0.4%	1 1.4%	0 0%	0 0%
Neutral	2 0.7%	2 2.9%	0 0%	0 0%
Agree	95 34.9%	80 114.3%	13 162.5%	2 0.6%
Strongly Agree	252 92.6%	189 270%	57 712.5%	6 1.7%

8. Other Pre-specified Outcome

Title	Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Pregnant Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	99	71	24	4
Pregnancies to participants with Issues of Female Origin	25 9.2%	20 28.6%	3 37.5%	2 0.6%
Pregnancies to participants with Issues of Male origin	11 4%	8 11.4%	3 37.5%	0 0%
Pregnancies to participants No infertility Issue	59 21.7%	39 55.7%	18 225%	2 0.6%
Pregnancies to participantsBoth Male and Female Infertility Issue	4 1.5%	4 5.7%	0 0%	0 0%

9. Other Pre-specified Outcome

Title	Comparison of Pregnancy Rate Based on Known Fertility Issue
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.

Outcome Measure Data

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
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.
Measure Participants	99	71	24	4
PCOS	12 4.4%	8 11.4%	3 37.5%	1 0.3%
Endometriosis Low AMH or low ovarian reserve	4 1.5%	4 5.7%	0 0%	0 0%
Vaginismus or vulvodynia	6 2.2%	6 8.6%	0 0%	0 0%
Tilted Uterus	4 1.5%	4 5.7%	0 0%	0 0%
Low Sperm Count	6 2.2%	5 7.1%	1 12.5%	0 0%
Sperm motility issues	4 1.5%	4 5.7%	0 0%	0 0%
Erectile Dysfunction	5 1.8%	5 7.1%	0 0%	0 0%
Performance issues or sexual anxiety, or inability to orgasm with partner	14 5.1%	14 20%	0 0%	0 0%
Unexplained infertility	10 3.7%	9 12.9%	0 0%	0 0%
No fertility issues reported	51 18.8%	32 45.7%	17 212.5%	2 0.6%

10. Other Pre-specified Outcome

Title	Insemination Schedule's Impact on Pregnancy
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.

Outcome Measure Data

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
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.
Measure Participants	99	71	24	4
1st cycle : at least 2 inseminations per cycle	52 19.1%	30 42.9%	10 125%	2 0.6%
1st cycle not meeting criteria	47 17.3%	41 58.6%	14 175%	2 0.6%
1st cycle not reporting	0 0%	0 0%	0 0%	0 0%
2nd cycles : at least 2 inseminations per cycle	18 6.6%	13 18.6%	4 50%	1 0.3%
2nd cycle not meeting criteria	24 8.8%	16 22.9%	6 75%	2 0.6%
2nd cycle not reporting	57 21%	42 60%	14 175%	1 0.3%
3rd cycles : at least 2 inseminations per cycle	5 1.8%	4 5.7%	1 12.5%	0 0%
3rd cycle not reporting	83 30.5%	62 88.6%	18 225%	3 0.9%
3rd cycle not meeting criteria	11 4%	5 7.1%	5 62.5%	1 0.3%
4th cycles : at least 2 inseminations per cycle	4 1.5%	4 5.7%	0 0%	0 0%
4th cycle not meeting criteria	2 0.7%	1 1.4%	0 0%	1 0.3%
4th cycle not reporting	93 34.2%	66 94.3%	24 300%	3 0.9%
5th cycles : at least 2 inseminations per cycle	0 0%	0 0%	0 0%	0 0%
5th cycle not meeting criteria	0 0%	0 0%	0 0%	0 0%
5th cycle not reporting	99 36.4%	71 101.4%	24 300%	4 1.1%
6th cycles : at least 2 inseminations per cycle	1 0.4%	0 0%	0 0%	1 0.3%
6th cycle not meeting criteria	0 0%	0 0%	0 0%	0 0%
6th cycle not reporting	98 36%	71 101.4%	24 300%	3 0.9%

11. Other Pre-specified Outcome

Title	Effect of COVID on Family Expansion
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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	350	272	70	80
Yes	89 32.7%	67 95.7%	22 275%	0 0%
No	261 96%	205 292.9%	48 600%	8 2.3%

12. Other Pre-specified Outcome

Title	Pregnancy Outcomes During COVID
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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregnancies	Heterosexual Females With a Male Partner	Females in LGBTQ Relationships	Solo Parent
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.
Measure Participants	99	71	24	8
Conception: September 2019 Birth: June 2020	1 0.4%	0 0%	1 12.5%	0 0%
Conception: October 2019 Birth: July 2020	3 1.1%	2 2.9%	1 12.5%	0 0%
Conception: November 2019 Birth: August 2020	5 1.8%	2 2.9%	3 37.5%	0 0%
Conception: December 2019 Birth: August 2020	4 1.5%	3 4.3%	0 0%	1 0.3%
Conception: January 2020 Birth: September 2021	3 1.1%	2 2.9%	1 12.5%	0 0%
Conception: February 2020 Birth: November 2021	10 3.7%	5 7.1%	5 62.5%	0 0%
Conception: March 2020 Birth: December 2021	7 2.6%	5 7.1%	2 25%	0 0%
Conception: April 2020 Birth: Jan 2021	16 5.9%	12 17.1%	2 25%	2 0.6%
Conception: May 2020 Birth: Feb 2021	11 4%	8 11.4%	3 37.5%	0 0%
Conception: June 2020 Birth: March 2021	19 7%	14 20%	5 62.5%	0 0%
Conception: July 2020 Birth: April 2021	17 6.3%	15 21.4%	1 12.5%	1 0.3%
Conception: August 2020 Birth: May 2021	2 0.7%	2 2.9%	0 0%	0 0%
Unknown	1 0.4%	1 1.4%	0 0%	0 0%

Adverse Events

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
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 (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.