Skip to main content
OpenTrials
Completed

NCT Number: NCT04646291

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Infertility, Female Infertility, Male Male Urogenital Diseases Urogenital Diseases

Study type

Observational

Primary location

Virtual Study - Online Data Collection

Austin, Texas, 78704, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insemination with the Mosie Baby Kit

Device

The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.

Primary outcomes

  1. Pregnancy Rate

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy.

  2. Cycle in Which Pregnancy Was Reported

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test.

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

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will measure the difference in pregnancy rates of Mosie Baby Kit users with known fertility issues and those without known fertility issues.

Secondary outcomes

  1. Ease of Use

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will examine the perceived ease of use of the Mosie Kit.

  2. Ease of Use: Usage Steps

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The use of the Mosie Kit requires several steps. In order to examine ease of use, each step was also examined individually. This table reports the data associated with each of use during each step of the insemination process.

  3. Use of the Kit as Intended

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will examine whether the user's used the Mosie Kit as described in the instructions and as intended.

  4. Perceived Safety of Using the Mosie Kit

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety.

Other outcomes

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

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will examine the resulting pregnancy rates of users self-identified as having a male infertility issue versus those having a female infertility issue and those having no reported fertility issue.

  2. Comparison of Pregnancy Rate Based on Known Fertility Issue

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue reported.

  3. Insemination Schedule's Impact on Pregnancy

    Time frame: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.

    The study examined pregnancy rates of users inseminating twice as expected as compared to using a different schedule. Four time points within each cycle were examined: 24-48 hours before ovulation, within 24 hours of ovulation, 24-48 hours after ovulation and 48 or more hours after ovulation. The recommended time frame is at least 2 insemination during the aggregate of 24-48 hours prior to ovulation and the within 24 hours of ovulation. The table below shows the data for how many women met the insemination criteria for each cycle that reported being pregnant.

    Note: Number of cycles reported by women vary from 1 cycle to 6 cycles. it is possible that a participant may have met the criteria at one cycle and not the other. Given this, the 3 arms when aggregated per row will equal the total of all participants. However, columns will not add up to the total participants per arm.

  4. Effect of COVID on Family Expansion

    Time frame: Pregnancies reported as conceived using the Mosie Kit during the months of December 2019 to February 2020 (Pre-COVID) will be compared to those reported for March - July 2020 (during COVID).

    The study will examine the effect of COVID on family expansion plans. The analysis will be provided in aggregate because the focus is on the impact of COVID on family expansion overall and not on whether one arm has more or less impact. This is a tertiary exploratory measure that does not evaluate the core product.

  5. Pregnancy Outcomes During COVID

    Time frame: Pregnancies reported as conceived using the Mosie Kit during the months of September 2019 to February 2020 (Pre-COVID) will be compared to those reported for March - August 2020 (during COVID).

    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.

Sponsors and collaborators

Lead sponsor

Mosie Baby

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2020
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.