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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Infertility, Infertility, Female, Infertility, Male

Intervention / Treatment
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* Device: Insemination with the Mosie Baby Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide implicit consent by filling out and submitting the survey. Used a Mosie Kit to conceive during at least one cycle. At least 18 years old. Has an active email on file (presumed or they would not have received an invitation to participate. This information will not be verified as there is a desire to keep the survey completely anonymous.) Exclusion Criteria: Never used a Mosie Kit

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heterosexual Females with a Male partner<br>This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle | Device: Insemination with the Mosie Baby Kit<br>* The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.<br>|
| Females in LGBTQ Relationships<br>This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle. | Device: Insemination with the Mosie Baby Kit<br>* The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.<br>|
| Solo parent<br>This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female. | Device: Insemination with the Mosie Baby Kit<br>* The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 
| Cycle in Which Pregnancy Was Reported | The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 
| Pregnancy Rate Differences Between Couples With Fertility Issues and Without | The study will measure the difference in pregnancy rates of Mosie Baby Kit users with known fertility issues and those without known fertility issues. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use | The study will examine the perceived ease of use of the Mosie Kit. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 
| Ease of Use: Usage Steps | The use of the Mosie Kit requires several steps. In order to examine ease of use, each step was also examined individually. This table reports the data associated with each of use during each step of the insemination process. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 
| Use of the Kit as Intended | The study will examine whether the user's used the Mosie Kit as described in the instructions and as intended. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 
| Perceived Safety of Using the Mosie Kit | The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insemination, Infertility, Pregnancy