InfertilityNCT04646291
Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
An observational study of Infertility and Infertility, Female, run by Mosie Baby at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility, Infertility, Female, Infertility, Male
- What is being tested?
- Insemination with the Mosie Baby Kit
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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.
Who may be able to join
- 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.)
Who cannot join
- Never used a Mosie Kit
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtual Study - Online Data Collection
Austin, Texas, 78704
About this study
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.
Read the 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.
- Conditions
- Infertility, Infertility, Female, Infertility, Male
- Being tested
- Insemination with the Mosie Baby Kit
- Keywords
- Insemination, Infertility, Pregnancy
- Medical subject headings
- Infertility, Infertility, Female, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insemination with the Mosie Baby KitDevice
The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
| Study group | Role | What they receive |
|---|---|---|
| Heterosexual Females with a Male partner | This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Receives: Device: Insemination with the Mosie Baby Kit | |
| Females in LGBTQ Relationships | This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle. Receives: Device: Insemination with the Mosie Baby Kit | |
| Solo parent | 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. Receives: Device: Insemination with the Mosie Baby Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy.
Measured: 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.
Measured: 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.
Measured: 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 (4)
Ease of Use
The study will examine the perceived ease of use of the Mosie Kit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start5 Aug 2020
- Primary completion31 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mosie Baby
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Karina Loyo PhD MBA CCDM, Mosie Baby
- Investigators
- Karina Loyo, PhD MBA CCDM, Principal investigator, Independent Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646291
- Sponsor's protocol ID
- Mosie-001
- Status last verified
- Jun 2021
- First submitted
- 13 Aug 2020
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Currently there is no plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit
- ClinicalTrials.gov ID
- NCT04646291
- Acronym / sponsor ID
- Mosie-001
- Conditions
- Infertility, Infertility, Female, Infertility, Male
- Keywords
- Insemination, Infertility, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Mosie BabyIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heterosexual Females with a Male partner | – | Device: Insemination with the Mosie Baby KitThis cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle |
| Females in LGBTQ Relationships | – | Device: Insemination with the Mosie Baby KitThis cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle. |
| Solo parent | – | Device: Insemination with the Mosie Baby KitThis 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. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (1 listed)
- Never used a Mosie Kit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insemination with the Mosie Baby KitThe participant will have performed at least one cycle of insemination using the Mosie Baby Kit. | Device | Females in LGBTQ Relationships, Heterosexual Females with a Male partner, Solo parent |
Primary outcome
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.
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Currently there is no plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Loyo, PhD MBA CCDM principal investigator
Independent Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Infertility, Female, run by Mosie Baby at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.