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

NCT04646291 | Completed Results FDA Device

• 1 other identifier: Mosie-001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Infertility, Female; Infertility, Male

Keywords

Insemination; Infertility; Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (4)

• Ease of Use

  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

  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

  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

  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 (5)

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

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

• Comparison of Pregnancy Rate Based on Known 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.

• Insemination Schedule's Impact on 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.

Study Arms (3)

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

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.

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.

Device: Insemination with the Mosie Baby Kit

Interventions

Insemination with the Mosie Baby Kit DEVICE

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

Females in LGBTQ Relationships; Heterosexual Females with a Male partner; Solo parent

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• Never used a Mosie Kit

Sponsors & Collaborators

• Mosie Baby: lead

Study Sites (1)

Virtual Study - Online Data Collection

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Infertility; Infertility, Female; Infertility, Male

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Karina Loyo, Ph.D., MBA, CCDM
• Organization: Mosie Baby (Consultant)

karina@drkarina.com

512-563-1393

Study Officials

• Karina Loyo, PhD MBA CCDM

  Independent Researcher

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: November 27, 2020
• Study Start: August 5, 2020
• Primary Completion: August 31, 2020
• Study Completion: September 1, 2020
• Last Updated: June 24, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)