Clinical trial NCT04646291: Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
Official title: Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Infertility, Female
Infertility, Male
Keywords: Insemination
Infertility
Pregnancy
Lead sponsor: Mosie Baby
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 350
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Rate
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Cycle in Which Pregnancy Was Reported
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Pregnancy Rate Differences Between Couples With Fertility Issues and Without
timeFrame: 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 outcomes:
measure: Ease of Use
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Ease of Use: Usage Steps
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Use of the Kit as Intended
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Perceived Safety of Using the Mosie Kit
timeFrame: 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 outcomes:
measure: Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Comparison of Pregnancy Rate Based on Known Fertility Issue
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Insemination Schedule's Impact on Pregnancy
timeFrame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
measure: Effect of COVID on Family Expansion
timeFrame: 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).
measure: Pregnancy Outcomes During COVID
timeFrame: 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).
Locations:
city: Austin
country: United States
facility: Virtual Study - Online Data Collection
state: Texas
Study officials:
affiliation: Independent Researcher
name: Karina Loyo, PhD MBA CCDM
role: PRINCIPAL_INVESTIGATOR
References: