Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
Conditions: Infertility, Infertility, Female, Infertility, Male
Sponsor: Mosie Baby

Retrospective Study on the
Use, Efficiency, and Safety of  
the at-home Mosie Kit
. 
Principal Investigator: Karina Loyo, Ph.D., MBA, CCDM
Funded by Mosie Baby
Protocol Number: MOSIE-001
Short Name: Mosie Kit Survey
Version Number: 1; this is the first version of the protocol.
July 31, 2020
CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes
agreement by the recipient that no unpublished information contained herein will be published or
disclosed without prior approval of the Principal Investigator or other participating study
leadership.

Table of Contents 
Table of Contents
2
Statement of Compliance
6 
Investigator’s Signature
6
1       PROTOCOL SUMMARY
7 
1.1      Synopsis
7 
1.2   Schema
9 
1.3      Schedule of Activities
9 
2 INTRODUCTION
10
2.1      Study Rationale
10 
2.2
Background
10
2.3      Risk/Benefit Assessment
12 
2.3.1
Known Potential Risks
12
2.3.2     Known Potential Benefits
13 
2.3.3 Assessment of Potential Risks and Benefits
13
3   OBJECTIVES AND ENDPOINTS
14 
4       STUDY DESIGN
16 
4.1
Overall Design
16
4.2      Scientific Rationale for Study Design
18 
4.3
Justification for Intervention
19
4.4      End-of-Study Definition
19 
5       STUDY POPULATION
19 
5.1      Inclusion Criteria
20 
5.2      Exclusion Criteria
20 
5.3      Lifestyle Considerations
20 
5.4   Screen Failures
20 
5.5   Strategies for Recruitment and Retention
21 
6    STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
22 
6.1 Study Intervention(s) or Experimental Manipulation(s) Administration
22
6.1.1     Study Intervention or Experimental Manipulation Description
22 
6.1.2
Administration and/or Dosing
22
6.2   Fidelity
22 
6.2.1
Interventionist Training and Tracking
22
6.3 Measures to Minimize Bias: Randomization and Blinding
22 
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6.4      Study Intervention/Experimental Manipulation Adherence
22 
6.5
Concomitant Therapy
23
6.5.1 Rescue Therapy
23 
7       STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL
23 
7.1   Discontinuation of Study Intervention/Experimental Manipulation
23 
7.2 Participant Discontinuation/Withdrawal from the Study
23 
7.3      Lost to Follow-Up
23 
8 STUDY ASSESSMENTS AND PROCEDURES
23
8.1   Endpoint and Other Non-Safety Assessments
23 
8.2 Safety Assessment
23
8.3 Adverse Events and Serious Adverse Events
24 
8.3.1 Definition of an Adverse Event
24
8.3.2     Definition of Serious Adverse Events
24 
8.3.3
Classification of an Adverse Event
24
8.3.3.1. Severity of Event
24 
8.3.3.2. Relationship to Study Intervention/Experimental Manipulation
24
8.3.3.3.  Expectedness
25 
8.3.4 Time Period and frequency of Event Assessment and Follow-up
25
8.3.5 Adverse Event Reporting
25 
8.3.6 Serious Adverse Event Reporting
26
8.3.7 Reporting Events to Participants
26 
8.3.8 Events of Special Interest
26
8.3.9 Reporting Pregnancy
26 
8.4 Unanticipated Problems
26
9       STATISTICAL CONSIDERATIONS
26 
9.1      Statistical Hypotheses and General Statistical Approach
26 
9.2      Sample Size Determination
29 
9.3    Populations for Analyses
30 
9.4      Statistical Analyses
30 
9.4.1     General Approach
30 
9.4.2  Sub-Group Analyses
30 
9.4.3     Exploratory Analyses
31 
1 0
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
31
10.1      Regulatory, Ethical, and Study Oversight Considerations
31 
10.1.1 Informed Consent Process
31
10.1.1.1 Consent/assent and Other Informational Documents Provided to 
participants
31
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10.1.1.2 Consent Procedures and Documentation
32 
10.1.2 Study Discontinuation and Closure
32
10.1.3     Confidentiality and Privacy
32 
10.1.4
Future Use of Stored Specimens and Data
33
10.1.5     Key Roles and Study Governance
33 
10.1.6
Safety Oversight
33
10.1.7     Clinical Monitoring
33 
10.1.8 Quality Assurance and Quality Control
33
10.1.9     Data Handling and Record Keeping
34 
10.1.9.1 Data Collection and Management Responsibilities
34
10.1.9.2 Study Records Retention
35 
10.1.10 PROTOCOL DEVIATIONS
35
10.1.11 Publication and Data Sharing Policy
35 
10.1.12
Conflict of Interest Policy
35
10.2   Additional Considerations
35 
10.3
Abbreviations and Special Terms
35
10.4   Protocol Amendment History
37 
11   REFERENCES
38 
Appendix A: Online Survey Tool and Consent Form (Google Form)
39
Appendix B: ​Frequently Asked Questions
81 
Appendix C: ​Participant Recruitment Emails
85 
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Statement of Compliance 
The trial will be conducted in accordance with International Council on Harmonisation Good
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations
 
 
 
 
 
 
 
 
 
 
 
 
 
(CFR); specifically the United States (US) Code of Federal Regulations (CFR) applicable to
 
 
 
 
 
 
 
 
 
 
 
 
 
clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CFR Part 812). The Principal Investigator will assure that no deviation from, or changes to the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
protocol will take place without prior documented approval from the Institutional Review Board
 
 
 
 
 
 
 
 
 
 
 
 
 
(IRB), and the Investigational Device Exemption (IDE) sponsor, if applicable, except where
 
 
 
 
 
 
 
  
 
 
 
necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in
 
 
 
 
 
 
 
 
 
 
 
 
  
the conduct of this study have completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will
 
 
 
 
 
 
 
 
 
 
 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
form(s) must be obtained before any participant is consented. Any amendment to the protocol
 
 
 
 
 
 
  
 
 
 
 
 
 
will require review and approval by the IRB before the changes are implemented to the study.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
All changes to the consent form(s) will be IRB approved; a determination will be made regarding
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
whether a new consent needs to be obtained from participants who provided consent, using a
  
 
 
 
 
 
 
 
 
 
 
 
  
previously approved consent form. 
Investigator’s Signature 
The signature below constitutes the approval of this protocol and provides the necessary 
assurances that this study will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable US federal regulations and ICH guidelines, as described in the 
Statement of Compliance​ above. 
 
Principal Investigator or Clinical Site Investigator: 
Signature:_______________________________________ Date: _____/______/2020 
Name: Karina Loyo, Ph.D. MBA, CCDM, Independent Researcher 
Investigator Contact Information 
Affiliation: Independent Consultant 
Address: 307 Champions Drive, Georgetown TX 78628 
Email: ​karina@drkarina.com 
Phone: 512-563-1393 
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1       PROTOCOL SUMMARY 
1.1
Synopsis
 
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Title: 
Retrospective Study on the Use, Efficiency and Safety of 
the at-home insemination Mosie Kit 
Study Description: 
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.  
Objectives*
: 
  
The primary objective is to understand how many people 
end up pregnant by using the at-home insemination Mosie 
Kit during up to 6 cycles of voluntary use and how many 
people get pregnant using the Mosie Kit without using sex 
because they are either single, in a same-sex relationship, 
or in an unconsumated mariage due to infertility problems. 
The secondary objectives are to understand perceived 
safety and ease of use of the at-home Mosie Kit.The 
tertiary objective will be to examine pregnancy outcome in 
relationship to self-reported reason for infertility. 
Additionally, since COVID-19 has recently affected 
everyone, its effect on family expansion plans and stress 
will also be examined. 
Endpoints*: 
The specific study endpoints include pregnancy rates after 
up to 6 cycles of at-home intracervical insemination (ICI), 
perceived ease of use, perceived safety, and the 
relationship of infertility source with pregnancy outcome 
rates, stress related to COVID-19 and its impact on family 
expansion plans. 
Study Population: 
The sample will be drawn from all people who have 
purchased an at-home Mosie Kit in the past 2-8 full months 
prior to the study commencement. The approximate 
sample size will be 500 but all will be invited to participate. 

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Both females and males will be included in the study. It is 
expected that the age range of the participants will vary 
from approximately 21 - 50 years of age. The participants 
will have a history of fertility problems, specifically 
problems getting pregnant. Otherwise, the participants 
should be in overall good health. No other health 
conditions are being used as exclusion criteria for 
participation in the study. Participants may be located 
anywhere in the world as this study will be conducted using 
an online web-based survey. 
Phase* or Stage: 
This is a post-market retrospective study to examine the 
experience people have with using the Mosie Kit for 
at-home insemination. 
Description of 
Sites/Facilities Enrolling 
Participants: 
No sites or facilities will be used in this study. Participants 
will be existing Mosie Baby Clients who have purchased a 
Mosie Kit in the prior 8 months.​ ​Participants may reside 
anywhere in the world​.  
Description of Study 
Intervention/Experimenta
l Manipulation: 
This is a retrospective study. Participants completing the 
study survey will have voluntarily purchased a Mosie Kit in 
the prior 8 months. Each participant will be asked to 
complete one study survey. Each participant will receive up 
to 5 email invitations to participate in the study. The study 
survey will be administered anonymously online on an 
individual basis.  
Study Duration*
: 
It is estimated that participants will complete the 
retrospective study survey within one month of receipt of 
the initial email requesting their participation.However, the 
study might continue until sufficient surveys are collected. 
Participant Duration: 
Participants will be able to complete all study related 
questions in less than 25 minutes (approximately 10-20 
minutes). 

1.2 
Schema 
Following is the flow of this study.
1.3      Schedule of Activities 
This study consists of completion of a one-time online survey. The following type of information
is contained within this one-time survey:
●
Informed consent
●
Demographics (includes gender, sexual identification, type of relationship. race,
ethnicity, household income and age. No identifying information will be requested)
●
Fertility history and diagnosis if any
●
Mosie Kit use and experience
●
Post-Mosie Kit use pregnancy success rate
●
Perceived safety
●
Perceived ease of use
●
Effect of COVID-19 on family expansion plans
●
Effect of COVID-19 on stress
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2
INTRODUCTION
2.1      Study Rationale 
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.
2.2
Background
Infertility is defined as not being able to get pregnant after one year of unprotected sex. About
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6% of married and overall 12% of women ages 15 to 44 have infertility issues. Infertility issues
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
can be of male or female origin. According to the CDC, in 35% of the infertility cases a male
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
factor was found along with a female factor and in 8% of the cases the only identifiable cause
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
was a male factor. Fertility is affected by multiple factors, one of which is the female’s age. For
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
this reason it is recommended that people anatomically female under the age of 35 seek help
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
after one year of trying to conceive while those over the age of 35 should seek help after 6
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
months. One of the first options available is artificial insemination. 
The first documented case of artificial insemination was done in the 1770s by John Hunger in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
London (Obmelet & Robays 2015). Subsequently J. Mario Sims reported his findings in the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
mid-1880s. Sims describes 55 inseminations. Unfortunately since he believed ovulation
 
 
 
 
 
 
 
 
 
 
occurred during meneses, only one pregnancy was reported (Obmelet & Robays 2015).
 
 
 
 
 
 
 
 
 
 
 
 
Research has come a long way since the early 18th century. Artificial insemination is now a
 
 
  
 
 
 
 
 
 
 
 
 
 
  
much more frequent occurrence. Initially used by couples with male infertility (low sperm count
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and inherited Y-chromosome disease), later for couples with
physiological and psychological
 
 
 
 
 
 
 
 
 
 
 
dysfunction, such as retrograde ejaculation, vaginismus, hypospadias and impotence, and now
 
 
 
 
 
 
 
 
 
 
 
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is very commonly used by people with no male partner (both single and those in lesbian
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
relationships).  
Since Dr. Sherman’s sperm freezing success in 1953 with a subsequent live birth, collecting and
 
 
 
 
 
  
 
  
 
 
 
 
 
using sperm for insemination in humans was made possible. However, it would be more than a
 
 
 
 
 
 
 
 
  
 
 
 
  
decade before it became legally possible as it was initially ruled as contrary to public policy and
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
good morals. In the 1960s and 70s, sperm selection and washing techniques led to Intrauterine
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
insemination (IUI) which placed the sperm even further into the woman's body by putting it
 
 
 
 
 
 
 
 
 
 
 
 
 
  
directly into the uterus. By the 1970s sperm banks in the US became popular. Also in the 1970s,
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
Steptoe and Edwards introduced the world to In-Vitro Fertilization (IVF). More recently,
 
 
 
 
 
 
 
 
 
 
 
 
techniques such as intratubal insemination, and intraperitoneal insemination have been added
 
 
 
 
 
 
 
 
 
 
 
to the available conception methods. During the last decades the popularity of Intrauterine
 
 
 
 
 
 
 
 
 
 
 
 
 
Insemination
(IUI)
increased
because
it
was
safer, painless, and more cost-effective.
 
 
 
 
 
 
 
 
 
 
 
Additionally, more information has become available about sperm selection techniques and now
 
 
 
 
 
 
 
 
 
 
 
 
there is a greater understanding of many of the causes of infertility. 
The most popular method of insemination is to use the husband's sperm (Artificial Insemination
 
 
 
 
 
  
 
 
 
 
 
 
 
by Homologous or Husband (AIH)). In some cases anonymous donor sperm is used.
 
 
 
 
 
 
 
 
 
 
 
 
 
Intracervical (ICI) or intravaginal insemination (IVI) are terms used interchangeably to describe
 
 
 
 
 
 
 
 
 
 
 
 
the insemination technique colloquially known as the “turkey baster method”. This method
 
 
 
 
 
 
 
 
 
 
 
 
consists of placing the semen into the vagina at or near the cervix. In the United States, IUI is
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
the most frequently doctor assisted technique. Some researchers have examined the success
 
 
 
 
 
 
 
 
 
 
 
 
rates of each technique. ICI/IVI has been found to have a per cycle pregnancy rate of 10-15%
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
while IUI has been found to be slightly higher up to 10-35%. Meanwhile techniques such as IVF
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
can be as high as 31% in people under 35 years of age and as low as 3% for those above 43
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
according to the CDC. 
 
Getting pregnant using IUI can cost $250-500 per insemination before accounting for the cost of 
the testing and other imaging done as part of the process. IVF is even more expensive and 
invasive. According to Katz et al. 2011, the median per-person cost of IVF was approximately 
$24,373 (for just IVF) to $38,015 (for IVF-donor egg). Voorhis et al. 1997 found ICI to cost 
$7.800-10,300 while Assisted Reproductive Therapy (ART) cost $37,00 - 76,000. The cost 
difference between IVI/ICI, IUI and ART therapies such as IVF is significant. This makes cost a 
consideration for people attempting to conceive.  
The good news is a number of studies such as Cohlen and Ombelet 2014 and Banerjee and
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
Singla 2017, demonstrate the viability of using IVI/ICI as a means of AIH. The benefits of ICI is
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
that it can be done in the privacy of the home, is relatively low cost, and over a 6 cycle time
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
frame seems to have comparable rates to its more expensive counterparts.  
Cohlen and Ombelet 2014 showed that for many couples with cervical factor infertility,
 
 
 
 
 
 
 
 
 
 
 
 
 
psychological sexual dysfunction, physiological dysfunction, unexplained infertility and mild to
 
 
 
 
 
 
 
 
 
 
moderate male subfertility using artificial insemination with a husband's sperm (AIH) was a
 
 
 
 
 
 
  
 
 
 
  
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preferred treatment option. Banerjee and Singla (2017), tested couples with unconsummated
 
 
 
 
 
 
 
 
 
 
 
marriages due to vaginismus, erectile dysfunction and premature ejaculation. They found 69%
 
 
 
 
 
 
 
 
 
 
 
 
of couples ages 20-32, 43% ages 33-36, and 25% over 36 years old conceived using IVI. This is
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
comparable to the expected 10-35% pregnancy rate of IUI. 
Additionally, Kop et al. 2018 conducted a literature review to determine if there was a difference 
between pregnancy rates and live births of IUI versus ICI. They reported that out of six trials 
totalling 708 women. They concluded that there was not enough evidence to determine that IUI 
resulted in more live births or pregnancies than ICI.  
Carroll and Palmer (2001) conducted a prospective randomized cross over control study on 62 
single fertile women choosing to use donor sperm. They had a total of 189 cycles (94 IUI and 95 
ICI). The resulting pregnancy rate was 15% and 9% respectively (p=0.04) which indicated that 
IUI was more effective than ICI. On the other hand, Hogerzeil et al. (1988) studied 53 women 
who either had at home ICI (n=29) or in clinic ICI (n=24). In the first 6 cycles 13 pregnancies 
resulted in the home ICI group while only 11 pregnancies resulted in the clinic group. 
Additionally, they followed 138 couples who did not meet the inclusion criteria. Of these 45 had 
opted for at home insemination and 20 of them ended up with a pregnancy.  
In conclusion, there is a lot of room to learn more about the pregnancy rates of ICI and the
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
experience of at-home artificial insemination. With 12% of women of child bearing age
 
 
 
 
 
 
 
 
 
 
 
 
 
experiencing infertility there is an important contribution to be made to the fertility field. Using
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the Mosie Baby at-home artificial insemination kit is a low cost option that could potentially be a
 
 
 
 
 
 
   
 
 
 
 
 
 
  
first line alternative for many people seeking to conceive. Therefore, it is important to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
understand the experience and pregnancy rates of people who have chosen to use the Mosie
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kit to get pregnant at home. This study will provide valuable information for the fertility industry
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
as a whole, as well as, will provide information for a follow up study where people choosing to
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
use the Mosie Kit will be prospectively followed to capture their data in real time. Together these
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
studies will provide a better understanding of at-home insemination success, safety and
 
 
 
 
 
 
 
 
 
 
 
 
perception.  
2.3
Risk/Benefit Assessment
2.3.1     Known Potential Risks 
Since this is a retrospective study and the participants will have already used the Mosie Kit,
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
there is no potential additional physical risk from participating in the study. In some cases,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
because fertility is a sensitive issue, some people might become a bit emotional in recalling
 
 
  
 
 
 
 
 
  
 
 
 
 
unsuccessful attempts to get pregnant. Otherwise, there are no known additional risks for
 
 
 
 
 
 
 
 
 
 
 
 
 
participating in this study.  
This retrospective study will be conducted as an anonymous one-time self-report survey that will
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contain no personal information that will allow the participant to be identified. This is done to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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reduce the risk of the information being associated with the individual providing the information.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This also ensures there are no immediate or long-term risks associated with participation. 
2.3.2     Known Potential Benefits 
The potential benefit of this study is mostly for people seeking to perform at-home intracervical
 
 
 
 
 
  
 
 
 
 
 
 
 
 
insemination in the future using the Mosie Kit. Each Mosie Kit provides syringes for two
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
inseminations to occur within a cycle at the cost of about $89. This is less than 20% of the cost
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
of IUI which can range between $500-1500/ procedure before labs, ultrasounds, and additional
 
 
 
 
 
 
 
 
 
 
 
 
expenses, and around 5% once all costs are added up. The study will provide valuable
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
information to people trying to conceive about the efficiency of using the Mosie Kit for ICI, how
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
that efficiency might compare to the effectiveness of IUI, and how the cost of each compares.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This will help the user decide whether the Mosie Kit is the right conception tool for them. The
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
study will also provide valuable information about the safety and usability of the kit. The
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
research will let Mosie know if they have successfully communicated how to use the kit, if the
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
instructions are clear or if any changes are needed, and whether anything else should be
 
 
 
  
 
 
 
 
 
 
 
 
 
 
considered in future design changes. The study might also provide information on the timing of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the insemination that might lead to a positive pregnancy outcome. Additionally, this knowledge
 
 
 
 
 
  
 
 
 
 
 
might provide Mosie Baby with information to help it position itself better in the market.. 
The participant themselves will only benefit by having been able to share their experience about
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the Mosie Kit. While they might receive a discount code towards the purchase of a future Mosie
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
Kit, this is not considered a benefit but a thank you for participation. Note the discount code will
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
be a standard code used for other marketing purposes in order to ensure there is no way for
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
Mosie staff to know if the participant obtained it for completing the survey or obtained it via other
 
 
 
  
 
 
  
 
 
 
 
 
  
 
 
marketing avenues. The participant may feel good because they shared their experience and
 
 
 
 
 
 
 
 
 
 
 
 
 
provided input into the Mosie Kit which will in turn help others. 
The information obtained through this study will allow Mosie Baby to enhance or clarify the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
instructions provided with the Mosie Kit and will be considered in future production of the Mosie
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
Kit.  
2.3.3 
Assessment of Potential Risks and Benefits 
As stated previously there is minimal risk to the subject because this a retrospective
 
 
 
 
 
 
 
 
 
 
 
 
 
 
observational study of the subject’s previously chosen voluntary behavior to purchase and use
the
Mosie Kit. There are also minimal to no benefits to the participants for completing the
survey except for their personal satisfaction of having shared and contributed to the research
via their experience(s). The benefit will mainly be for people who will use the Mosie Kit in the
future and who will benefit by being able to try the Mosie Kit before they resort to more
expensive and invasive methods of getting pregnant. It is believed that the good of many and
future possibility of having an acceptable method of artificial insemination at home outweighs
the risk of participation in the study.
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3 
OBJECTIVES AND ENDPOINTS 
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OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR
ENDPOINTS
PUTATIVE
MECHANISMS OF
ACTION
Primary 
  
 
  
The primary 
objective is to 
understand the 
outcome of using 
the at-home 
intracervical 
insemination Mosie 
kit, i.e. pregnancy 
rate after its use. 
 
 
The primary endpoints 
is: 
Pregnancy Rate after 
up to 6 cycles.  
 
Another primary end 
point is to understand 
the rates of pregnancy 
in people who desire 
to get pregnant 
without intercourse
(i.e. both single and 
those in LGBTQ 
relationships.  
The ultimate objective of 
using the Mosie Kit is to end 
up pregnant. Thus 
pregnancy rate is a primary 
endpoint. Specifically, 
pregnancy rate in up to 6 
(six) cycles will be examined 
as it is the typical standard 
timeframe for attempting to 
get pregnant using IVI or IUI 
before seeking an alternative 
method. 
People who have no known 
fertility issue who are trying 
to conceive without 
intercourse such as those 
who are in LGBTQ 
relationships or those who 
are not in any relationship at 
all will likely have higher 
pregnancy rates than those 
with known fertility issues of 
female origin.
Women in LGBTQ 
relationships wishing to 
conceive might also have a 
higher pregnancy rate than 
those in heterosexual 
relationships where infertility 
might be caused by things 
like low sperm count, sperm 
motility issues or erectile 
dysfunction (ED). 
The Mosie Kit is 
intended to be used 
to deposit semen at 
or near the cervix 
where the sperm will 
have an increased 
likelihood of entering 
the uterus and 
pairing up with the 
ovum resulting in a 
pregnancy. 
 
Pregnancy rates 
increase when sperm 
reaches the ovum 
and fertilizes it. In 
people with no known 
fertility issues, the 
Mosie kit deposits the 
semen where it is 
able to fertilize the 
ovum.  
 
People without 
infertility issues who 
want to get pregnant 
without sex by using 
the Mosie Baby are 
also more likely than 
people with known 
fertility issues to get 
pregnant. 

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Secondary 
  
 
  
The secondary 
objective(s) are to 
understand the 
user’s experience 
with the Mosie Kit 
and it’s safety. 
 
 
Secondary endpoints 
are: perceived ease of 
use and perceived 
safety.  
  
The perceived ease of use 
is being examined as a 
secondary endpoint 
because being able to 
follow the instructions and 
use the kit as designed 
will directly affect whether 
the semen is deposited at 
or near the cervix having a 
direct effect on the results. 
Perceived ease of use is 
viewed as a mediating 
variable. 
Finally, perceived safety 
of the Mosie Kit will be 
examined. It is expected 
to be a moderating 
variable.  
 In order for the 
delivery of sperm at 
or near the cervix, 
the user needs to 
maximize the sperm 
drawn up into the 
Mosie syringe, insert 
it into the vagina, and 
deposit the sperm at 
or near the cervix. 
Because the Mosie 
syringe is inserted 
into the vagina, it is 
important to 
understand any 
perceived issues or 
concerns related to 
safety and use of the 
syringe. 
Tertiary/Exploratory
The tertiary 
objective will be to 
examine the 
pregnancy rate of 
people with different 
self-reported 
sources of infertility. 
 
Given the 
Pandemic, 
exploratory effect of 
COVID-19 on family 
planning, stress and 
pregnancy results 
will be examined. 
Because the reason 
for a person’s or 
couple’s infertility 
might affect pregnancy 
rates, the reason for 
the infertility will also 
be examined. This will 
provide information as 
to whether the Mosie 
Kit is more effective 
given a specific source 
of infertility.  
 
The pandemic has 
caused an overall 
increase in stress, 
higher stress can 
affect fertility. 
The source of infertility 
may play a mediating role 
in a successful pregnancy. 
For example, it might be 
more likely that a couple 
with a woman with no 
known infertility issue 
using Mosie might be 
more likely to get pregnant 
than a woman with a 
specific known infertility 
issue.  
Stress can play a 
mediating role in 
pregnancy. Concern over 
future stability and 
Women who do not 
have a fertility issue 
might be more likely 
to get pregnant when 
the sperm is 
successfully 
deposited at or near 
the cervix. For 
example, this would 
help if the infertility 
was rooted in Erectile 
Dysfunction (ED). 
 
Stress hormones can 
affect pregnancy 
outcome. Stressful 
and uncertain times 
make people more 

 
4       STUDY DESIGN 
4.1
Overall Design
This is a post-market retrospective cross-sectional observational study of people using the
 
 
 
 
 
 
 
 
 
 
 
 
Mosie Kit for at-home insemination. The goal of the study is to understand the pregnancy rate
resulting from using the Mosie Kit of people with known fertility issues or those wishing to
conceive without intercourse due to medical reasons such as vaginismus or being in a LGBTQ
relationship desiring a child.
This study uses a convenience sample of people who purchased the Mosie Kit in the past 8
complete months prior to the commencement of the study. The complete known list of people
will be invited to participate in the study. For the primary hypothesis 1, all study participants will
be treated as one group initially. Subsequently, the study participants may be divided into
groups according to their age, the type of relationships (heterosexual or LGBTQ), and/or source
of infertility to examine the hypothesis as it relates to these subgroups if sufficient sample size
indicates this is appropriate; this analysis corresponds to the tertiary hypothesis.
Primary hypothesis 1: Pregnancy rates using the at-home insemination Mosie Kit to
deposit semen near or at the cervix (i.e. intracervical insemination) are equivalent or
better than traditional in doctor’s office intrauterine insemination.
Given the participants can either be people with fertility issues or people in LGBTQ relationships
without known problems conceiving or single women wishing to conceive, another primary
hypothesis that will be examined is the difference of pregnancy rates in each of these groups.
Specifically, the primary hypothesis related to this is as follows:
Primary Hypothesis 2: Pregnancy rates of LGBTQ people or single women using the
Mosie Kit where the female has no know fertility issues will be higher than that of
heterosexual people with a known fertility cause or those that are designated as having
an unexplained fertility issue.
The secondary hypothesis will examine the use of the Mose Kit and its safety as perceived and
reported by the study participants. For these hypotheses the participants will be examined as
one group as well as categorized by age group and type of relationship. Specifically, the
secondary hypothesis will be as follows:
Secondary Hypothesis 1: The participants perceived the Mosie Kit to be easy to use for
its intended purpose.
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Additionally, family 
planning may be 
affected. 
uncertainty can affect 
family planning.  
prone to put off 
expanding their 
families. 

Secondary Hypothesis 2: The participants were able to use the Mosie Kit as instructed
 
 
 
 
 
 
 
 
 
 
 
 
 
 
using the instructions contained in the kit. 
Secondary Hypothesis 3: The participants reported they used the kit as intended,
 
 
 
 
 
 
 
 
 
 
 
 
specifically, using it within 24 hours of initial signs of ovulation and again 24-48 hours
 
  
 
 
 
 
 
 
 
 
 
 
 
 
after ovulation was confirmed or expected. 
Secondary Hypothesis 4: Participants reported they perceived the Mosie Kit to be a safe
 
 
 
 
 
 
 
 
 
 
 
  
 
way to conceive. 
Secondary Hypothesis 5: The majority of participants indicate they have little to no safety
 
 
 
 
 
 
 
 
 
 
 
 
 
 
concerns related to using the Mosie Kit. 
The tertiary hypothesis for this study dives further into the primary hypothesis by breaking out
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the participants into groups based on their type of relationship and the source of their infertility
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to examine their cohort specific pregnancy rates.  
Tertiary Hypothesis 1: There will be higher pregnancy rates when using the Mosie Kit
 
 
 
 
 
 
 
 
 
 
 
 
 
 
when the source of infertility is male-based than when infertility is female-based.  
Tertiary Hypothesis 2: There is a difference in pregnancy rates of people or couples with
 
 
 
   
  
 
 
 
 
 
 
 
known fertility issues depending on the source of their infertility. Specifically, the
 
 
 
 
 
 
 
 
 
 
 
 
following sources of infertility will be examined if sufficient data is available.  
○
PCOS 
○
Endometriosis 
○
Low AMH or low ovarian reserve 
○
Low sperm count 
○
Sperm motility issues 
○
Unexplained infertility 
○
Erectile dysfunction  
○
Performance issues or sexual anxiety, or inability to orgasm with partner. 
○
Vaginismus or vulvodynia 
○
Tilted uterus 
○
Multiple uterus/cervix 
○
Loss of a fallopian tube 
Tertiary Hypothesis 3: There will be a difference between individuals who perform 2 
insemination instances as described in the instructions and those that follow a different 
schedule or dosage number. 
Additionally since we are in the midst of a pandemic with COVID-19, exploratory analysis will be 
conducted on the stress levels and its impact on family expansion plans. 
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Tertiary Hypothesis 4: COVID-19 has affected people’s family expansion plans. 
Tertiary Hypothesis 5: There will be a decrease in pregnancy rates in those using the 
Mosie Kit during the Months of March - June. 
This study does not use randomization. While no control group will be examined for the study,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
determining the result of some of the hypotheses is based on using the reported pregnancy rate
of IUI in the literature. Specifically, the reported rate of pregnancy with IUI is as high as 20% in
one cycle according to the American Pregnancy Association. According to the CDC, it can
range between 10-35% across 6 cycles.
4.2
Scientific Rationale for Study Design
The retrospective cross-sectional study design was selected because the desire is to examine
 
 
 
 
 
 
 
 
 
  
 
 
the pregnancy rates and perception of useability and safety of the Mosie Kit. Since this is a
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
post-market study, the use of an existing group of participants who voluntarily purchased and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
used the Mosie Kit exists and provides an excellent group of participants to study. The past
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
experiences of these participants will provide valuable information for future participants on the
 
 
 
 
 
 
 
 
 
 
 
 
 
success rate of at-home insemination, information as to the ease of use of the instructions
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
included in the kit, ease of use of the kit, and perceived safety.  
The rationale for examining the participants first as a complete cohort and then stratified by type
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
of relationship, infertility source, and age group is that the primary hypotheses relate to overall
 
 
 
 
 
 
  
 
 
 
 
 
 
 
pregnancy rates using the at-home insemination Mosie Kit and the rate of pregnancy in women
 
 
 
 
 
 
 
 
 
 
 
 
  
 
without a known fertility cause wanting to get pregnant without intercorse. The type of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
relationship is also important because a woman in an LGBTQ relationship without fertility issues
  
 
 
  
  
 
 
 
 
 
 
is more likely to easily get pregnant than a heterosexual female with fertility issues once the
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
semen is deposited at or near the cervix. While there might be LGBTQ women that also have a
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
known cause of fertility, they will be examined by type or relationship as well as by infertility
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
source. Likewise, single women will be categorized by their known infertility source or as not
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
having a known fertility issue. It is important to study the difference between the two groups and
  
 
 
   
 
 
 
 
 
 
 
 
 
 
explore the impact on the overall pregnancy rate of Mosie Kit users. 
Additional hypotheses aim to examine more specifics related to each stratification. For example,
 
 
 
 
 
 
 
 
 
 
 
 
 
age is known to affect fertility rates. Women ages 20-30 are more likely to get pregnant than
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
those in their 40s. The source of infertility may also indicate underlying biological or physical
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
issues that might mediate the pregnancy rates causing different rates of success in each of the
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
groups. All the information obtained through this study will be used to benefit people who are
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
trying to get pregnant and are experiencing infertility issues. Specifically, the study will examine
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the viability and success rate of at-home insemination. 
Another benefit of conducting a retrospective study is being able to examine the natural use of
 
 
 
  
 
  
 
 
 
 
 
 
 
 
the Mosie Kit. While instructions are provided as to how and when to use the Mosie Kit for
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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insemination, it is known that there will be a variation of use among study participants. This
  
 
 
 
 
 
  
 
 
 
 
 
 
 
might affect the pregnancy outcome. Therefore, one of the tertiary hypotheses will collect
 
 
 
 
 
 
 
 
 
 
 
 
 
information related to timing and dosing (with dosing being the instance of insemination). This is
 
 
 
 
 
 
 
 
 
 
 
 
 
  
important because the results will help provide information that will help ensure future studies
 
 
 
 
 
 
 
 
 
 
 
 
 
 
have clearer instructions and so that all users regardless of study participation optimize the use
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of the Mosie Kit in order to get pregnant. 
4.3      Justification for Intervention 
This is a retrospective cross-sectional study of existing users of the Mosie Kit. Participants will
be recruited via email. Specifically, it is planned that participants will receive up to 5 email
invitations to participate in the study, however more emails might be used to recruit sufficient
participants.. The email will direct them to the study survey where they will read the consent
form and choose to participate in the study. The email will contain a link to the survey. If they
elect to participate, they will complete the study survey and submit it online. Participation
consists of completing a 10-20 minute survey. This is a one time survey. Since no identifying
information will be collected, there will be no possibility of follow up.
There is no intervention. This study merely looks at the past experience of using the Mosie Kit. It
is important to know the success rates of pregnancy with at-home insemination kits, and
understand the usability and safety as there are individuals and couples using these types of
options on a regular basis as a means to get pregnant. For people who suffer from infertility,
having this information will help them choose whether ICI is right for them and whether the
Mosie Kit should be chosen for this method. Additionally, since age is a factor in pregnancy
success and risks increase with age, there is a need to understand the success of at home ICI
so recommendations can be made as to whether to use ICI and how long to use it before
seeking other methods of conception. This study aims to address some of these issues.
4.4
End-of-Study Definition
It is expected that the study will be completed within 30 days of the initial email. This will provide
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants with an opportunity to find 10-20 minutes to participate in the study during a 30 day
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
window. Participants will receive up to three additional reminder emails at least 7 days apart and
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
one final email 2 days prior to study close. Participants who choose to participate in the study
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
will be considered to have completed the study upon submission of the complete survey. If
 
 
 
 
 
 
 
 
 
 
 
 
 
  
sufficient participants have not completed the survey, the study timeframe may be expanded at
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the discretion of the PI. 
5       STUDY POPULATION 
The study population will consist of all individuals who have purchased the Mosie Kit in the past
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
2-8 complete months prior to study initiation. All qualifying individuals will receive an invitation to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participate. These individuals will typically be of child-bearing age, both females and males, and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
generally ages ranging 18-50 years old.  
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It is assumed that purchasing the Mosie Kit means the kit will be used as intended for at-home
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
insemination. One of the inclusion criteria is to have previously used the kit. Therefore, the initial
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
list of study participants will be drawn from people who have placed a purchase order within the
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
prior 8 complete months; complete months are used with the expectation that the Mosie Kit
  
 
 
 
 
 
 
 
 
 
 
 
 
 
would be used within the month post-purchase. If the study duration is expanded, additional
 
 
 
 
 
 
  
 
 
 
 
 
potential participants will be invited who have purchased the kit at least 2 full months prior to
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
being invited to participate in the study. 
5.1      Inclusion Criteria 
In order to be included in the study, the following inclusion criteria will be used. 
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.) 
5.2
Exclusion Criteria
The following exclusion criteria will be used. 
●
Never used a Mosie Kit 
5.3
Lifestyle Considerations
There are no exclusions due to lifestyle considerations as this is a one time cross-sectional 
survey of past experiences. 
 
5.4 
Screen Failures 
Participants who are consented to participate in the study, and who do not meet one or more
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
criteria required for participation in the trial during the screening procedures, are considered
 
 
 
 
 
 
 
 
 
 
 
 
 
screen failures. If an individual identifies their age as less than 18 years old or as not having
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
used the Mosie Kit which will be the first 2 questions, then the survey will automatically end.
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
These participants will be designated as screen failures. Screen failures will not be rescreened
 
 
 
 
 
 
 
 
 
 
 
 
 
 
or included in the study in the future as this study is expected to have a very short duration
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
(approximately 30 days). 
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5.5
Strategies for Recruitment and Retention
Recruitment of participants will be conducted via a direct email campaign. Participants will
 
 
 
 
 
 
  
 
 
 
 
 
receive multiple emails requesting their participation in the study. Specifically they will receive
emails according to the following schedule:
If the study duration is expanded, a weekly email and a reminder a couple of days prior to the
new deadline will be sent. 
Typical response rates vary between 5-30% for email surveys. The rate of response is higher
 
 
 
 
 
 
 
 
 
 
 
 
  
 
when people have a connection with the company or product. They also go up with repeated
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
reminders and incentives to participate. A good survey response rate is about 50%.  
Participants who complete the survey will receive a code to purchase a future Mosie Kit at a
discount. This discount code will also be a code used in other marketing efforts in order to help
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
reduce the likelihood a participant’s status of participating in the study will remain masked.  
The expected response rate for this study is between 30-50%.This response rate is expected
 
 
 
 
 
 
 
 
 
 
 
  
 
because the potential participants will have all previously purchased a Mosie Kit. Additionally,
 
 
 
 
 
 
 
 
  
 
 
 
the Mosie Newsletter has about a 20% open rate so it is expected that participation might be
 
 
 
 
  
 
 
 
   
 
 
 
 
 
slightly higher than this. 
Because participants will only be selected from people who have previously purchased a Mosie
Kit there will be a limit in the mix of people available for selection for study participation. This
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
means the results might not be generalizable to the public in general, nonetheless it is a
 
 
 
 
 
 
 
 
 
 
 
 
  
  
representative sample of the people who would do at-home insemination. 
 
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Email Content 
Expected Date 
Initial Email 
Initial Invitation to participate 
Day 0 
Second Email
Reminder of invitation to participate
Day 7
Third Email 
Reminder of invitation to participate 
Day14 
Fourth Email 
Last week to participate survey 
Day 21 
Fifth Email 
Final email - 2 days left to complete 
survey 
Day 28 

6 
STUDY INTERVENTION(S) OR EXPERIMENTAL 
MANIPULATION(S)
6.1
Study
Intervention(s)
or
Experimental
Manipulation(s)
 
 
 
 
 
Administration
6.1.1     Study Intervention or Experimental Manipulation Description
This is a cross-sectional retrospective observational study of people who have selected to
 
 
 
 
 
 
 
 
 
 
 
 
 
voluntarily purchase and use the Mosie Baby at-home insemination kit. No additional
 
 
 
 
 
 
 
 
 
 
 
 
intervention or manipulation is planned for this study. 
6.1.2     ​Administration and/or Dosing 
This study retrospectively examines the administration and dosing of semen during insemination 
in the home environment by using the Mosie Kit. The recommended dosing of semen to 
produce a positive pregnancy outcome is at least 2 times in a cycle. With the first dose 
preferably administered within 24 hours of the first signs of ovulation and the second one 
between 24-48 hours post ovulation confirmation. Since this study is retrospective, it will not 
influence dosing, but merely will collect information on the dosing frequency and timing.  
 
6.2 
Fidelity 
While this study will look backwards onto how the Mosie Kit was used and resulting pregnancy 
rates, it also affords the opportunity to examine variations in timing of the insemination with 
respect to ovulation as well as the frequency of insemination within a cycle. The study will not 
influence how the Mosei Kit was used, but it is hoped that the information gathered will add 
understanding to whether timing and frequency might have played a role in pregnancy results. It 
is important to study how people use Mosie because timing and dosage might impact the 
pregnancy rate. It is also important to understand the variations in use. 
6.2.1
Interventionist Training and Tracking
No intervention will be performed. 
6.3 Measures to Minimize Bias: Randomization and Blinding 
This study will not have any masking or randomization. It is a retrospective study. Participant 
selection bias will be minimized by including all people who have purchased a Mosie Kit in the 
prior 2-8 whole months.  
 
 
6.4      Study Intervention/Experimental Manipulation Adherence 
This study does not have an intervention. However data will be collected on the 
self-administered intervention that will be examined retrospectively. The data will allow 
determination as to whether the minimum intervention was followed, i.e. administration of two 
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at-home insemination instances one within 24 hours of initial signs of ovulation and one at 24-48 
hours after confirmed ovulation. 
6.5      Concomitant Therapy 
N/A 
6.5.1 Rescue Therapy 
N/A 
7       STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL 
7.1   Discontinuation of Study Intervention/Experimental Manipulation 
N/A
7.2 Participant Discontinuation/Withdrawal from the Study
Participants may choose to leave the survey at any time without submitting the completed 
survey. There will be no way to know which participant did not complete the survey or why the 
survey was not completed. There will be no way to follow up with the participant to request 
continued participation as the survey will not contain any identifying information.  
There will be no replacement participants. Any incomplete surveys will be discarded 
automatically by the system. They will not be available for use in the final analysis.  
7.3      Lost to Follow-Up 
N/A
8
STUDY ASSESSMENTS AND PROCEDURES
8.1 
Endpoint and Other Non-Safety Assessments 
The only assessment for this study will be one online survey which can be completed in
approximately 10-20 minutes. The survey will collect demographics information, relationship
status, infertility history, experience using the Mosie Kit and perceptions related to its use and
safety.
8.2 Safety Assessment
Since there is no intervention there will be no safety assessments related to the survey 
however, questions about the perceived safety of using the Mosie Kit Syringe will be asked. 
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8.3 Adverse Events and Serious Adverse Events 
This retrospective study does not expect there to be any adverse events reported due to
participating in the survey. It does however ask questions about any infections that might have
occurred during the prior 7 months. While these infections might be completely unrelated to
using the Mosie syringe, the response will be evaluated and examined as a percentage of
respondents and cycles. It is one of the goals of this study to find out if there might be any
adverse events due to the use of the Mosie Kit.
Nonetheless, the definitions and classification for adverse events are outlined below.
8.3.1 Definition of an Adverse Event 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward
medical occurrence associated with the use of an intervention in humans, whether or not
considered intervention-related. However, as a cross-sectional study, only retrospective
information will be available if provided by the Participant.
8.3.2 Definition of Serious Adverse Events
According to the FDA a serious adverse event is one that results in death, disability, require and 
intervention to prevent a disability or permanent damage, birth defect or hospitalization. ER 
visits without hospitalization are individually evaluated for their severity to determine if they are a 
serious adverse event. 
8.3.3 Classification of an Adverse Event
8.3.3.1. Severity of Event 
For adverse events (AEs) not included in the protocol defined grading system, the following 
guidelines will be used to describe severity. 
●
Mild – Events require minimal or no treatment and do not interfere with the participant’s
  
 
 
 
 
 
 
 
 
 
 
 
 
 
daily activities. 
●
Moderate – Events result in a low level of inconvenience or concern with the therapeutic
  
 
   
 
 
 
 
 
 
 
 
 
measures. Moderate events may cause some interference with functioning. 
●
Severe – Events interrupt a participant’s usual daily activity and may require systemic
  
 
  
 
 
 
 
 
 
 
 
drug therapy or other treatment. Severe events are usually potentially life-threatening or
 
 
 
 
 
 
 
 
 
 
 
 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
8.3.3.2.  Relationship to Study Intervention/Experimental Manipulation 
All adverse events (AEs) will have their relationship to study procedures, including the
intervention, assessed by an appropriately-trained clinician based on temporal relationship and
his/her clinical judgment. The degree of certainty about causality will be graded using the
categories below.
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●
Definitely Related – There is clear evidence to suggest a causal relationship,
 
  
 
 
 
 
 
  
 
 
and other possible contributing factors can be ruled out. The clinical event,
 
 
 
 
 
 
 
 
 
 
 
 
including
an
abnormal
laboratory
test
result, occurs in a plausible time
 
 
 
 
 
 
 
 
 
 
 
relationship to study procedures administration and cannot be explained by
 
 
 
 
 
 
 
 
 
 
concurrent disease or other drugs or chemicals. The response to withdrawal of
 
 
 
 
 
 
 
 
 
 
 
 
the
study
procedures
should be clinically plausible. The event must be
 
 
 
 
 
 
 
 
 
 
 
pharmacologically or phenomenologically definitive. 
●
Probably Related – There is evidence to suggest a causal relationship, and the
 
  
  
 
 
  
 
 
 
 
influence of other factors is unlikely. The clinical event, including an abnormal
 
 
 
 
 
 
 
 
 
 
 
 
laboratory test result, occurs within a reasonable time after administration of the
 
 
 
 
  
 
 
 
 
 
 
study procedures, is unlikely to be attributed to concurrent disease or other drugs
 
  
 
 
 
 
 
 
 
 
 
 
or chemicals, and follows a clinically reasonable response on withdrawal. 
●
Potentially Related – There is some evidence to suggest a causal relationship
 
  
 
 
 
 
 
  
 
 
(e.g., the event occurred within a reasonable time after administration of study
 
 
 
 
  
 
 
 
 
 
 
procedures). However, other factors may have contributed to the event (e.g., the
 
 
 
 
 
 
 
 
 
 
 
 
participant’s clinical condition, other concomitant events). Although an AE may
 
 
 
 
 
 
 
 
 
 
rate only as “possibly related” soon after discovery, it can be flagged as requiring
 
 
 
 
 
 
 
  
 
 
 
 
 
more information and later be upgraded to “probably related” or “definitely
 
 
 
 
 
 
 
 
 
 
 
related”, as appropriate. 
●
Unlikely to be related – A clinical event, including an abnormal laboratory test
 
 
 
  
 
 
 
 
 
 
 
 
result, whose temporal relationship to study procedures administration makes a
 
 
 
 
 
 
 
 
  
causal relationship improbable (e.g., the event did not occur within a reasonable
 
 
 
 
 
 
 
 
 
  
 
time after administration of the study procedures) and in which other drugs or
 
 
 
 
 
 
 
 
 
 
 
 
 
chemicals or underlying disease provides plausible explanations (e.g., the
 
 
 
 
 
 
 
 
 
participant’s clinical condition, other concomitant treatments). 
●
Not
Related
–
The
AE
is completely independent of study procedures
 
 
 
 
 
 
 
 
 
 
 
administration, and/or evidence exists that the event is definitely related to
 
 
 
 
 
 
 
 
 
 
 
another etiology. There must be an alternative, definitive etiology documented by
 
 
 
 
 
 
 
 
 
 
 
the clinician. 
8.3.3.3.  Expectedness  
There are no expected adverse events for this study.  
8.3.4 Time Period and frequency of Event Assessment and Follow-up
This retrospective study will only capture past self-reported vaginal infections. There will be no 
way to tell if it was a potentially related adverse event of the Mosie Kit use in a one time survey. 
No additional follow-up will be conducted. No identifying information will be collected to allow 
follow up. 
8.3.5 Adverse Event Reporting
Adverse Events will be captured via the survey but will have occurred in the past. Due to the 
nature of this study, it will not be possible to follow-up with participants reporting these AEs. 
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8.3.6 Serious Adverse Event Reporting 
It is unlikely that there will be any SAEs related to the Mosie Kit. Even if a participant reveals an 
SAE, because identifying information will not be collected, it will be impossible to follow up. 
8.3.7 Reporting Events to Participants 
N/A 
8.3.8 Events of Special Interest 
Only the events associated with the use of the Mosie Kit will be captured via the survey. If there 
are any concerns of special interest, the information will be shared immediately with Mosie. This 
complete study is expected to take approximately 30 days. At the latest, the information will be 
reviewed for any special items of interest within 2 weeks of the study completion. 
8.3.9 Reporting Pregnancy 
Pregnancy status will be obtained during the survey. It is not used as an exclusion factor. It is 
used as an outcome measure. 
8.4 Unanticipated Problems 
Given the nature of a cross-sectional one-time survey no unanticipated events are expected.
9
STATISTICAL CONSIDERATIONS
9.1      Statistical Hypotheses and General Statistical Approach 
The primary objective is to understand the outcome of using the Mosie kit for Intracervical
insemination, i.e. pregnancy rate after its use. Specifically the hypothesis is as follows.
Primary hypothesis 1: Pregnancy rates using the at-home insemination Mosie Kit to
 
 
 
 
 
 
 
 
 
 
 
 
deposit semen near or at the cervix (i.e. intracervical insemination) are equivalent or
 
 
 
 
 
 
 
 
 
 
 
 
 
better than traditional in doctor’s office intrauterine insemination (IUI). Conversely the
 
 
 
 
 
 
 
 
 
 
 
null hypothesis is that the pregnancy rates using the at-home insemination Mosie Kit to
 
  
 
 
 
 
 
 
 
 
 
 
 
deposit semen near or at the cervix do not have higher rates of pregnancy than in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
doctor’s office IUI. 
Analysis: Comparison of total rates of pregnancy using the Mosie Kit to the 10-20% rate
 
 
 
 
 
 
 
 
 
 
 
 
 
 
reported for IUI by the American Pregnancy Association.  
Primary Hypothesis 2: Pregnancy rates of LGBTQ couples or single women using the
 
 
 
 
 
 
 
 
 
 
 
 
 
Mosie Kit where the female has no know fertility issues will be higher than that of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
heterosexual couples with a known fertility cause or those that are designated as having
 
 
  
 
 
 
 
 
 
 
 
 
 
an unexplained fertility issue. The alternative hypothesis is that people with no known
 
 
 
 
 
 
 
 
 
 
 
 
 
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fertility issues using the Mosie Kit will have less pregnancies than heterosexual couples
 
 
 
 
 
 
 
 
 
 
 
 
 
with known fertility issues. 
Analysis: Rate of pregnancy using the Mosie Kit will be obtained for the following groups:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LGBTQ couples where carrying female has no known fertility issues, LGBTQ couples
 
 
 
 
 
 
 
 
 
 
 
 
where carrying female has a known fertility issue, Heterosexual people with no known
 
 
 
  
 
 
 
 
 
 
 
 
fertility issue, Heterosexual people with a known fertility issue, Single females with no
 
 
 
 
  
 
 
 
 
 
 
 
known fertility issue and Single females with a known fertility issue. The rates of each
 
 
 
 
 
 
  
 
 
 
 
 
 
 
group will be analyzed using descriptive statistics and the aggregate of the 3 groups with
 
 
 
 
 
 
 
 
 
 
 
  
 
 
fertility issues will be compared with the aggregate of the 3 groups without fertility issues.
 
 
 
 
 
 
 
 
 
  
 
 
 
 
An ANOVA will be used to compare the differences between groups.
Secondary Hypothesis 1: The participants perceived the Mosie Kit to be easy to use
 
 
 
 
 
 
 
 
 
 
 
 
 
for its intended purpose. The alternative hypothesis is that the participants perceive the
 
 
 
 
 
 
  
 
 
 
 
 
Mosie Kit to be difficult to use for its intended purpose. 
Analysis: Descriptive statistics surrounding the ease of use on a 5-point likert (very easy
 
 
 
 
 
 
 
 
  
 
 
 
 
to very difficult) will be analyzed on five different aspects of use. Specifically, the steps of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
using the Mosie Kit (collecting a sperm sample, drawing up the sample in the Mosie
 
 
 
 
  
 
 
 
 
 
 
 
 
 
syringe, inserting the syringe, and depositing the sperm at or near the cervix) and overall
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ease of use will be examined. Additionally questions related to use such as comfort,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ease and safety of the process, enjoyable and intuitiveness of use (able to use it without
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
instructions) will allow the user to rate their experience from Strongly agree to strongly
 
 
 
 
 
 
 
 
 
 
 
 
 
 
disagree (5 point scale). The data will be plotted and examined as part of the analysis. 
Secondary Hypothesis 2: The participants were able to use the Mosie Kit as instructed
 
 
 
 
 
 
 
 
 
 
 
 
 
 
using the instructions contained in the kit. The alternative hypothesis is that the
 
 
 
 
 
 
 
 
 
 
 
 
 
participants were not able to use the kit using the instructions contained in the kit. 
Analysis: Descriptive analysis of perceived overall success rate will be analyzed.
 
 
 
 
 
 
 
 
 
 
 
Additionally, descriptive analysis of the frequency of each expected behavior related to
 
 
 
 
 
 
 
 
 
 
 
 
use of the kit will be examined.  
Secondary Hypothesis 3: The participants reported they used the kit as intended,
 
 
 
 
 
 
 
 
 
 
 
 
specifically, using it within 24 hours of initial signs of ovulation and again 24-48 hours
 
  
 
 
 
 
 
 
 
 
 
 
 
 
after ovulation was confirmed or expected. The alternative hypothesis is that the
 
 
 
 
 
 
 
 
 
 
 
 
participants report they did not use the kit as intended with respect to timing (within 24
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
hours of initial signs of ovulation and again 24-48 hours post ovulation). 
Analysis: Frequency rates related to timing of insemination at all reported cycles will be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
analyzed. The data will be reported in both total number of attempts at each time point
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
as well as percentage of attempts at each time point in comparison with total cycles
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
where the Mosie Kit was used. T-tests will also be used in this analysis. Additionally,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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amount of time lying after insemination and position of lying will be analysed using
 
 
 
 
 
 
 
 
 
 
 
 
 
 
descriptive statistics and correlations with pregnancy rate.  
Secondary Hypothesis 4: Participants reported they perceived the Mosie Kit to be a
 
 
 
 
 
 
 
 
 
 
  
safe way to conceive. The alternative hypothesis is that participants did not perceive the
 
 
 
 
 
 
  
 
 
 
 
 
 
Mosie Kit to be a safe way to conceive. 
Analysis: Descriptive statistics will be used to analyze perceived safety. Qualitative
 
 
 
 
 
 
 
 
 
 
 
analysis will be used on any comments made related to safety. Rates of vaginal
 
 
 
 
 
 
 
 
 
 
 
 
 
 
infections will be analyzed using descriptive statistics. 
Secondary Hypothesis 5: The majority of participants indicate they have little to no
 
 
 
 
 
 
 
 
 
 
 
 
 
safety concerns related to using the Mosie Kit. Alternative hypothesis is the majority of
 
 
 
 
 
 
 
 
 
  
 
 
 
participants will be very concerned or extremely concerned about the safety of using the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mosie Kit. 
Analysis: Descriptive statistics of self-reported level of concern. Additionally, safety
 
 
 
 
 
 
 
 
 
 
measures such as hand washing, disposing of the syringe after use, and reading the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
instructions will be examined using descriptive statistics. 
Tertiary Hypothesis 1: There will be higher pregnancy rates when using the Mosie Kit
 
 
 
 
 
 
 
 
 
 
 
 
 
 
when the source of infertility is male-based than when it is female-based. The alternative
 
 
 
 
  
 
 
   
 
 
 
hypothesis is there will be lower pregnancy rates when using the Mosie Kit when the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
source of infertility is male-based than when it is female-based. 
Analysis: In addition to the descriptive statistics a t-test will be run to examine this
 
 
 
 
 
 
  
 
 
 
 
 
 
 
hypothesis. 
Tertiary Hypothesis 2: There is a difference in pregnancy rates of people with known
 
 
 
 
  
 
 
 
 
 
 
 
 
fertility issues depending on the source of their infertility. Specifically, the following
 
 
 
 
 
 
 
 
 
 
 
 
sources of infertility will be examined if sufficient data is available.  
○
PCOS 
○
Endometriosis 
○
Low AMH or low ovarian reserve 
○
Low sperm count 
○
Sperm motility issues 
○
Unexplained infertility 
○
Erectile dysfunction  
○
Performance issues or sexual anxiety, or inability to orgasm with partner. 
○
Vaginismus or vulvodynia 
○
Tilted uterus 
○
Multiple uterus/cervix 
○
Loss of a fallopian tube 
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The alternative hypothesis is that there will be no difference in the fertility rates 
associated with different sources of infertility. 
Analysis: Descriptive statistics, t-test, correlations and multiple ANOVAs will be used to 
examine this hypothesis.  
Tertiary Hypothesis 3: There will be a difference between individuals who perform 2 
insemination instances as described in the instructions and those that follow a different 
schedule or dosage number. The alternate hypothesis is that there will be no difference 
between the individuals that perform the minimum 2 insemination instances and those 
that follow  difference dosage schedule. 
Analysis: Descriptive statistics of pregnancy rates for groups with 1, 2, 3 and 4 or more 
inseminations per cycle will be used. These rates will then be compared to determine if 
there is a difference. 
Tertiary Hypothesis 4: COVID-19 has affected people’s family expansion plans. The 
alternate hypothesis is that COVID-19 has had no effect on people’s family expansion 
plans. 
Analysis: Descriptive analysis and a t-test will be conducted to examine this hypothesis. 
Tertiary Hypothesis 5: There will be a decrease in pregnancy rates in those using the 
Mosie Kit during the Months of March - June. 
Analysis: Descriptive statistics, graphing, ANOVA and multiple regression analysis will 
be used to examine this hypothesis. 
Additional Analysis will also be conducted to explore why people might choose to use 
the Mosie Kit, how they actually use it, additional things they do when using the Mosie 
Kit to complement the experience, and whether they think their health care provider 
should recommend Mose as an conception option. Most of this analysis will be achieved 
using descriptive statistics, correlations, and t-tests. 
9.2      Sample Size Determination 
The desired final sample size for this study is 500 completed surveys. This will produce a 95%
confidence interval with +/- 4.4% within larger populations. In order to obtain that rate of
respondents, the study will invite about 50% people who have ordered a Mosie Kit in the prior
2-8 months to the study start date. It is expected that approximately 4000 people will be invited
to participate. By inviting 4000 potential participants, it is expected that with a response rate of
15% approximately 600 will complete the survey. Currently Mosie has about a 20% open rate
on their general emails. For this reason, all people who purchased a kit within the last 2-8
months will be invited to participate.
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According to the sample size tables, a response rate of 384 is sufficient to provide a 95%
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
confidence interval with a 5% margin of error rate. While the total number of respondents can
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
not be controlled, every effort will be made via the reminder emails to obtain at least 500
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants but no less than 384. 
9.3    Populations for Analyses 
The population to be analyzed include any one using the Mosie Kit in the full 2-8 months prior to
study commencement. Respondents can be male or female. Overall the data will be analyzed
as a whole and stratified by sex (having ovaries and a uterus as indication of being a female),
age and type of relationship .
9.4
Statistical Analyses
9.4.1     ​General Approach 
Statistical analysis will commence with descriptive statistics for each survey question and 
plotting of the individual data into scatter plots to understand the data distribution.If any 
information suggests corrective procedures should be employed, the appropriate transformation 
or non-parametric test will be used. 
Categorical values will be reported using descriptive statistics and frequency of occurrence. Key 
categorical values will also be converted into a percentage of total responses in order to allow 
an understanding of the prevalence of the response in the sample. For continuous variables, the 
means with standard deviations, median and range will be reported. 
Qualitative data is only expected as a response to two questions, an open ended safety 
question and an additional comments question.The responses will be evaluated and 
categorized. Then the frequency of each category will be provided. 
For inferential tests such as t-tests and ANOVAs, a p-value of 0.05 and a confidence interval of 
95% will be used for statistical significance. The type of hypothesis will determine whether the 
specific tests will be one-tailed or two-tailed. Hypothesis seeking to understand whether there is 
or is not a difference will use a two-tailed test while those seeking a greater than or less than 
relationship will use a one-tailed test. Correlations among some of the variables will also be 
examined as appropriate. 
Statistical analysis process for each hypothesis has already been described in section 9.1. No 
baseline analysis is used for cross-sectional studies. No interim analyses are planned for 
cross-sectional one survey studies. 
9.4.2 
Sub-Group Analyses 
All endpoints (primary, secondary and tertiary) will be analyzed based on age, sex, 
race.ethnicity, SES, relationship preference, male/femaile infertility issues. Only aggregate 
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information will be used in the final analysis. No tabulation of individual participant data will be 
used in reporting findings. 
9.4.3     Exploratory Analyses 
Additional exploratory data analysis will be conducted to examine the main characteristics of the 
data. This analysis will be done using descriptive statistics, scatter plots, and odds ratio. If the 
exploratory analysis warrants the testing of new hypotheses, t-test or ANOVA may be used for 
further analysis. 
Exploratory modeling will be conducted to examine multiple variables and their relationship to 
the pregnancy outcome. This will include the source of infertility, age, number of inseminations, 
number of cycles, lying time, and type of relationship. The model will use correlations and 
goodness of fit tests in its analysis. 
1 0 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS
10.1      Regulatory, Ethical, and Study Oversight Considerations 
10.1.1 Informed Consent Process 
Upon receiving the invitation email, the potential participant will select to follow the study link. In
the study web page, the user will be provided with information related to the study and consent
to participate in the study. They will be informed that if they choose to respond to the questions
and submit their responses, they are providing consent. They will agree to participate in the
research by selecting “Yes” to “Do you agree to participate in this study?”. No signature will be
collected as the intent is for the study to be completely anonymous.
Waiver of signed consent was selected for this study in order to be able to ensure the anonymity
of the participant in this cross-sectional post-elective-intervention study. Since participants
previously elected to use the Mosie Kit and now are selecting to share their experiences and
perceptions about it, they need only share these experiences; there is no reason to collect any
identifying information for this one time survey.
10.1.1.1
Consent/assent and Other Informational Documents Provided to participants 
A consent form describing in detail the study procedure and risks will be displayed to the
participant upon access to the study website using the link provided in the email. Each
participant will be able to read and provide consent. The participant may print the displayed
consent. Additionally, the email will contain a link to a Frequently Asked Question Document
where the participant can learn more about the study.
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10.1.1.2
Consent Procedures and Documentation 
After reading the consent form, the participant can elect to proceed to the survey or conclude
the survey. The only documentation collected about the consent is whether or not the participant
elected to respond to the questions. A consent is not required for participation in this study.
Answering the questions and submitting the responses provides consent. Only completed
surveys that are submitted will end up in the database.
10.1.2 Study Discontinuation and Closure 
It is not expected that the study will end prematurely. The expected total duration of study data
collection is approximately 30 days. However, if the minimum number of surveys are not
collected within the 30 day time-frame, the study will continue collecting data for up to 90 days.
Since this is a one-time anonymous survey there is no reason to follow up with the participant.
There is also no way to follow up with any given participant should there be a desire to do so
since the surveys will be responded to completely anonymously.
Should there be any reason to discontinue the study prematurely, the PI will advise the study
Sponsor and the institutional review board (IRB) of this occurrence. Circumstances that might
warrant termination or suspension might include:
●
Difficulties with the data capture/survey technology
●
Difficulties with participant recruitment
●
Data that are not sufficiently complete and/or evaluable
●
Determination of a need to prematurely complete the study as determined by the PI,
Sponsor, IRB or regulatory agency.
The study may resume once concerns about data quality and data security are addressed, and
satisfying any requirements of the Sponsor, IRB, or regulatory agency.
The study may be terminated prematurely if sufficient surveys are completed prior to the 30
days of data collection. This will be done at the discretion of the Primary Investigator (PI).
10.1.3     Confidentiality and Privacy 
Participation in this study is completely anonymous. Participants will receive an invitation email
with a generic link to the study website. Once informed about the study and its participation, the
participant can respond to the survey questions without entering any identifiable information.
The PI deemed the value of obtaining any identifying information was inferior to protecting the
participant’s privacy and that it was unnecessary for this study. Therefore, no identifying
information will be collected. There will be no identifiers that can link directly back to an
individual. While information about race, gender, and age will be collected, it will not be possible
to point the information back to any given individual.
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Invitations to participate will be sent out by the Sponsor company. The full list of those emails 
will never be released to the PI. This will help keep the information from being able to be linked 
back to the group of emails sent. 
The final database will be an anonymous database that will be the property of the Sponsor. 
There is currently no intent to share the results of that study beyond this research. There is an 
intent to publish the findings of the study as a journal article and for information on the 
Sponsor’s company website, but this information will be limited to aggregate results and to 
discussions related to the findings. The Sponsor might also use aggregate data or results in 
future marketing materials. 
10.1.4     ​Future Use of Stored Specimens and Data 
Specimens are not part of this study. Therefore no storage of specimens is required. 
Data collected for this study will be analyzed and stored as an anonymous de-identified 
database in the possession of the PI and at Mose Baby. The archived data will be stored for use 
by Mosie Baby. No one will be given access to the raw study data without the written consent of 
the PI or Mosie Baby. 
10.1.5     Key Roles and Study Governance 
Principal Investigator: 
Karina Loyo, Ph.D., MBA, CCDM  
Clinical Research Consultant 
307 Champions Drive, Georgetown, TX 78628 
512-563-1393 
karina@drkarina.com 
This one time survey does not require a medical monitor or safety oversight as no interventions 
are occurring.  
10.1.6     Safety Oversight 
Safety oversight is provided by the Institutional Review Board (IRB) who is responsible for 
independently reviewing this study to ensure protection of human subjects. This study will seek 
exempt approval Category2(i) since the research is an observation of public behavior and the 
information obtained is recorded in such a manner that the identity of the human subjects 
cannot be readily ascertained, directly or through identifiers linked to the subject.. 
10.1.7     Clinical Monitoring 
N/A 
10.1.8 Quality Assurance and Quality Control 
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This one time survey does not require clinical monitoring or an external QA process. Quality 
Assurance is conducted to ensure the quality of data is complete and that appropriate 
documentation is in place to support and conduct the study. 
Quality Control (QC) Procedures will be implemented as follows: 
●
Informed Consent - PI and Sponsor will both review the documentation of the 
consenting process. This review will be conducted in compliance with GCP, accuracy 
and completeness. Feedback will be provided to the PI and Sponsor in order to ensure 
proper consenting procedures are followed. The Institutional Review Board will also 
review and provide feedback on this process. 
●
Source Documents and the electronic data - The electronic data capture will 
constitute the source documents for this study. The data will be entered by the 
participant directly into the final study database. 
●
Intervention fidelity - This is a retrospective observational study of people using the 
Mosie Kit. Part of data collection will include information about the use of the kit and how 
it was used. This information will be used to determine whether the person used the kit 
as intended thus confirming the intervention fidelity occurred voluntarily prior to 
participation in the study. 
●
Protocol Deviations - There is no directed intervention for this study. Therefore, 
protocol deviations with respect to an intervention are not expected. If any deviations 
occur with relation to how the data is collected or the participants recruited, that will be 
collected as part of the study documentation. 
There is no expectation that independent monitoring would be necessary. However, if it is 
required, the necessary arrangements will be made. 
10.1.9     ​Data Handling and Record Keeping 
The following section pertains to data handling and record keeping. It is described in 
accordance with GCP standards. 
10.1.9.1
Data Collection and Management Responsibilities  
Google forms will be used to collect this one time survey. The only data quality checks that will 
be included in the survey will be those that are implemented via the appropriate selection of the 
type of field in order to ensure the appropriate data is entered into the field and edit checks to 
ensure all questions are filled in.  
The online Google Form and resulting excel sheet will constitute the source data for this study. 
No external records or information will be combined with the survey data. Only the PI and the 
Sponsor will have access to download the data.  
Data standards will be implemented for the study. Descriptive field names will be used for each 
field. All data collection is the responsibility of the PI. The PI is responsible for ensuring the 
accuracy and completeness of the data. 
 
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10.1.9.2
Study Records Retention  
Study documents will be retained for a minimum of 3 years. No records will be destroyed without 
the written consent of the Sponsor. It is the responsibility of the Sponsor to inform the PI when 
these documents are no longer needed. 
10.1.10PROTOCOL DEVIATIONS  
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol 
and International Council on Harmonization Good Clinical Practices (ICH GCP). The non 
compliance may be either on the part of the participant or the investigator. Since this is a 
one-time survey, no deviations are expected. If any deviations do occur, they will be 
documented and corrective action plans will be implemented promptly. 
10.1.11 Publication and Data Sharing Policy 
This study will result in data that is proprietary to the Sponsor. As such, this data will be held 
privately and will only be shared at the discretion of the Sponsor.  
The trial will be registered with and the results of the analysis will be submitted to 
ClinicalTrials.gov. In addition, every attempt will be made to publish results in a peer-reviewed 
journal(s). Aggregate data may also be shared in any format by the Sponsor.  
10.1.12     ​Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, is critical. In order to 
ensure the integrity of this research, any conflict of interest of persons who have a role in the 
design, conduct, analysis, publication or any aspect related to the trial will be disclosed and 
managed. The PI reports that this study is a work for hire by the Sponsor. There is no other 
known conflict of interest. 
10.2 Additional Considerations 
No additional considerations. 
10.3 Abbreviations and Special Terms 
Below is a list of abbreviation or special terms used in this study protocol. 
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AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CRF
Case Report Form

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eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
GCP
Good Clinical Practice
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Council on Harmonisation 
IDE 
Investigational Device Exemption 
IRB
Institutional Review Board
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
NIH 
National Institutes of Health 
NIH IC
NIH Institute or Center
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC
Quality Control
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOP 
Standard Operating Procedure 
UP
Unanticipated Problem
US 
United States 

10.4 Protocol Amendment History 
The table below is intended to capture changes of IRB-approved versions of the protocol,
including a description of the change and rationale. A Summary of Changes table for the
current amendment is located in the Protocol Title Page.
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Version
Date
Description of Change
Brief Rationale
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

11 
REFERENCES 
Banerjee, K., & Singla, B. (2017). Pregnancy Outcome of Home Intravaginal Insemination in
Couples with Unconsummated Marriage. Journal of human reproductive sciences, 10(4),
293–296. https://doi.org/10.4103/jhrs.JHRS_5_17
Carroll, N. and Palmer, J.R. (2001). A comparison of intrauterine versus intracervical
insemination in fertile single women. Fertility and Sterility. 75: 4.
Division of Reproductive Health, National Center for Chronic Disease Prevention and Health
Promotion
Hogerzeil, H.V., Hamerlynck, J.V., van Amstel, N., Nagelkerke, N.J.D., and Lammes, F.B.
(1988). Results of artificial insemination at home by the partner with cryopreserved donor
semen: a randomized study. Fertility and Sterility. 49(6): 1033-1035.
https://doi.org/10.1016/S0015-0282(16)59956-7
Katz, P., Showstack, J., Smith, J. F., Nachtigall, R. D., Millstein, S. G., Wing, H., Eisenberg, M.
L., Pasch, L. A., Croughan, M. S., & Adler, N. (2011). Costs of infertility treatment: results from
an 18-month prospective cohort study. Fertility and sterility, 95(3), 915–921.
https://doi.org/10.1016/j.fertnstert.2010.11.026
Kop, P. A., Mochtar, M. H., O'Brien, P. A., Van der Veen, F., & van Wely, M. (2018). Intrauterine
insemination versus intracervical insemination in donor sperm treatment. The Cochrane
database of systematic reviews, 1(1), CD000317.
https://doi.org/10.1002/14651858.CD000317.pub4
Ombelet, W. and Robays, J.V. (2015). Artificial Insemination History: Hurdles and Milestones.
Facts Views and VISION in OBGYN. 7(2):137-143. Accessed online at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4498171/
Van Voorhis BJ, Sparks AE, Allen BD, Stovall DW, Syrop CH, Chapler FK. Cost-effectiveness of
infertility treatments: a cohort study. Fertil Steril. 1997;67(5):830-836.
doi:10.1016/s0015-0282(97)81393-3
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Appendix A:
Online Survey Tool and Consent Form  
(Google Form)
. 
This section shows what the Google Form will look like to the study participant. These are the
questions the participant will be asked.
The first page of the study contains the consent form and the question that confirms the
participant’s agreement to participate.
There is skip logic for certain sections. For example, if the participant selects one cycle of using
Mosie, the information related to cycles 2-6 will be skipped. If the participant selects that she is
pregnant the questions related to the pregnancy will be asked, otherwise they will be skipped. If
a donor was used, the questions related to producing a sperm sample will be skipped.
Note: Final language and questions might be tweaked or revised at any time to increase clarity.
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This is the inclusion/exclusion form. 
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If Participant selected to not participate in the study, he/she will see this screen next. If the 
participant said he/she is not 18 or older or has not used Mosie this screen will be displayed. 
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Qualifying participants will continue the survey on this page.
 
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Appendix B:
Frequently Asked Questions 
.
The frequently asked questions will be hosted by Mosie Baby on their website. There will be a 
hyperlink within the survey tool on the consent form allowing participants to be able to access 
the frequently asked questions at any time. 
The following page shows the text of the FAQ. 
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Frequently Asked Questions 
Study Name: ​Retrospective Study on the Use, Efficiency, and Safety of the at-home Mosie 
Kit 
Short Study Name: ​Mosie Kit Survey 
Principal Investigator: Karina Loyo, Ph.D., MBA, CCDM 
Contact Information: 512-630-0990 or karina@drkarina.com 
Why am I being asked to participate in this study? 
You are being asked to participate because we are interested in learning about your experience 
using the Mosie Kit for at-home insemination. Since you have purchased at least one kit, we 
hope that you have had an opportunity to use it and can share your experience. 
How long will the survey take? 
It is expected that most people will be able to complete the survey in about 15-30 minutes. 
Do I have to participate? 
No. Participation is optional, although we would really appreciate your help! The feedback you 
provide is crucial for us to improve the experience for others in the future. 
Will the survey be anonymous or will I have to identify myself? 
The survey is completely anonymous. While we will ask some questions about your 
demographics (ex. race, age, income, preferred relationship), nothing will be able to identify you 
as the person submitting the responses. In fact, Mosie will be sending the invitations, but our 
external primary investigator will be the one receiving the results in a completely separate 
database that can never be linked. 
Do you want both of us to participate by filling out a survey? Or do you have a preference 
about who fills it out? 
We would prefer to have the person who was inseminated respond to the survey. But if they are 
not able to fill it out, you are welcome to fill it out on their behalf. 
Can I forward the link to a friend? 
Please only forward to friends who have used the Mosie syringe. One of the reasons we are 
using a general link is to allow you to share it if you desire and the other is to make sure we 
keep your responses anonymous. 
I noticed the survey is being conducted in a google form. Is my data safe? 
Yes. The information you provide is transmitted safely into our Principal Investigator’s custody. 
Access to it is password protected. The only person who will be able to access the survey data 
during the data collection period will be the principal investigator, who does not have access to 
the email list. 
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Is the Principal Investigator an employee of Mosie Baby? 
No, the Principal Investigator is an independent consultant hired by Mosie Baby to conduct the 
research. 
Will I be compensated for my time? 
There is no cash compensation for participating in the study. However, in appreciation for 
sharing your experience and your time, Mosie will provide you with a discount code to be used 
on your next purchase. Using this discount code will not identify you as having participated in 
the study as we have used it before in a prior marketing campaign. We selected this code 
because it will help keep your participation anonymous. 
What do you hope to learn from our responses? 
We hope to learn about your experience using the Mosie Kit. We are studying how well people 
understand our instructions and the effectiveness of doing at-home insemination with Mosie 
Baby.  
Are there any risks involved in participating in the study? 
There are no known risks for participating in the study. You will be asked about your conception 
history which can be a trigger for some folks, and if this is too much, please know you do not 
have to complete the survey and can exit at any time. Please know that by exiting the survey 
your answers will not be submitted at all. 
Why is Mosie Baby doing this study? 
Mosie Baby cares about its community and wants to continuously improve to meet your fertility 
needs for at-home insemination. This study will provide us some valuable information about the 
product and your experience. 
How is this clinical research study different from a marketing survey? 
Marketing surveys focus on people’s purchasing behaviors. This clinical research study focuses 
on your experience with Mosie and the experience of others like you. The purpose is to 
understand your interaction with and use of the kit, the ease of use, identify any concerns over 
safety, understand the rates of pregnancy, and what if anything people are doing that could be 
beneficial when doing at-home insemination. 
Additionally, this study has been reviewed by an Independent Review Board who has 
determined that the study has been designed to protect your rights as a participant and will in no 
way endanger you. The study is also registered with clinicaltrials.gov. 
Will the results be published? 
We do plan to analyze and publish the results. We hope that the information we gain will not 
only be valuable for Mosie, but also to the whole fertility industry. There is very little research on 
the effectiveness of at-home insemination so this study will definitely add to the general 
knowledge about its effectiveness.  
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Can I withdraw at any time? 
Yes. You have the right not to participate and the right to withdraw at any time. One of the 
reasons the google forms was selected is that if you choose to end your participation before 
submitting the survey, none of the data will be posted into the database. If you choose to stop 
mid-survey you can close your browser and no data will be recorded. 
What happens if I stop the survey somewhere in the middle? 
Only completed surveys where the user clicks the Submit button at the end of the survey end up 
posting to the study database. Be sure to click submit when you are done to send the 
information to the database. 
Can I get my name taken off the list of reminders as I already completed the survey or 
decided not to participate?  
Absolutely, please send an email to ​mosie@mosiebaby.com​ to be taken off the list. In the email 
simply include the title: Remove from SURVEY list. 
There is no need to provide any additional information. That way, we won’t know if you 
participated or not. Note: This will not take you off Mosie’s regular mailing list, that takes a 
separate request. 
How many surveys do you hope to get? 
We hope to get around 500 completed surveys. This will allow us to analyze the data and have 
strong significance in our findings. 
How long do you think it will take to get all those surveys? 
Our Mosie community is very engaged. We strongly believe we can have all the needed surveys 
within 30 days. However, if more time is needed, we can continue to receive responses. 
What if I have additional questions about this survey? Is there anyone I can call? 
Yes. You can call the Principal investigator directly, her contact information is at the top of this 
page as well as below.  
Karina Loyo, Ph.D., MBA, CCDM 
512-630-0990  
karina@drkarina.com 
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Appendix C:
Participant Recruitment Emails  
.
This section contains samples of the participant recruitment emails. 
Note: These are samples. Final language and appearance might be tweaked. 
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Initial Email 
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Second email (approximately 1 week later) 
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Third Email (approximately 2 weeks after initial email) 
Fourth email (third week) 
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Final email reminder (approximately 24 hours prior to study close) 
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