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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646291
• Other study ID #: Mosie-001
• Status: Completed
• Start date: August 5, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: June 2021
• Source: Mosie Baby
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 1, 2020
• Est. primary completion date: August 31, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility, Male

Intervention

Device:
• Insemination with the Mosie Baby Kit
The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.

Locations

Country	Name	City	State
United States	Virtual Study - Online Data Collection	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mosie Baby

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status	The study will examine the resulting pregnancy rates of users self-identified as having a male infertility issue versus those having a female infertility issue and those having no reported fertility issue.	Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Other	Comparison of Pregnancy Rate Based on Known Fertility Issue	The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue reported.	Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Other	Insemination Schedule's Impact on Pregnancy	The study examined pregnancy rates of users inseminating twice as expected as compared to using a different schedule. Four time points within each cycle were examined: 24-48 hours before ovulation, within 24 hours of ovulation, 24-48 hours after ovulation and 48 or more hours after ovulation. The recommended time frame is at least 2 insemination during the aggregate of 24-48 hours prior to ovulation and the within 24 hours of ovulation. The table below shows the data for how many women met the insemination criteria for each cycle that reported being pregnant.; Note: Number of cycles reported by women vary from 1 cycle to 6 cycles. it is possible that a participant may have met the criteria at one cycle and not the other. Given this, the 3 arms when aggregated per row will equal the total of all participants. However, columns will not add up to the total participants per arm.	Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Other	Effect of COVID on Family Expansion	The study will examine the effect of COVID on family expansion plans. The analysis will be provided in aggregate because the focus is on the impact of COVID on family expansion overall and not on whether one arm has more or less impact. This is a tertiary exploratory measure that does not evaluate the core product.	Pregnancies reported as conceived using the Mosie Kit during the months of December 2019 to February 2020 (Pre-COVID) will be compared to those reported for March - July 2020 (during COVID).
Other	Pregnancy Outcomes During COVID	The study will examine whether there were more or less pregnancy rates during COVID. This measure will be an aggregate measure of all women. It is an exploratory measure to understand the impact of COVID. No data will be provided by study arm.	Pregnancies reported as conceived using the Mosie Kit during the months of September 2019 to February 2020 (Pre-COVID) will be compared to those reported for March - August 2020 (during COVID).
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.