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临床试验/NCT04646291
NCT04646291已完成不适用

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

Mosie Baby1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
Cycle in Which Pregnancy Was Reported

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

接受健康志愿者

入选标准

  • 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.)

排除标准

  • Never used a Mosie Kit

结局指标

主要结局

Cycle in Which Pregnancy Was Reported

时间窗: 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

时间窗: 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.

Pregnancy Rate Differences Between Couples With Fertility Issues and Without

时间窗: 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.

次要结局

  • 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.)
  • 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.)
  • 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.)

研究者

发起方
Mosie Baby
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Karina Loyo PhD MBA CCDM

Research Consultant

Mosie Baby

研究点 (1)

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