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

NCT ID: NCT04646291

Last Updated: 2021-06-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2020-09-01

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.

Conditions

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Infertility Infertility, Female Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Insemination with the Mosie Baby Kit

Intervention Type DEVICE

The participant will have performed at least one cycle of insemination using 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.

Insemination with the Mosie Baby Kit

Intervention Type DEVICE

The participant will have performed at least one cycle of insemination using 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.

Insemination with the Mosie Baby Kit

Intervention Type DEVICE

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

Interventions

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Insemination with the Mosie Baby Kit

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

Intervention Type DEVICE

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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Mosie Baby

INDUSTRY

Sponsor Role lead

Responsible Party

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Karina Loyo PhD MBA CCDM

Research Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karina Loyo, PhD MBA CCDM

Role: PRINCIPAL_INVESTIGATOR

Independent Researcher

Locations

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Virtual Study - Online Data Collection

Austin, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Mosie-001

Identifier Type: -

Identifier Source: org_study_id

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