An observational study in Infertility, Infertility, Female and Infertility, Male, sponsored by Mosie Baby. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by Mosie Baby · Observational
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 350 is above the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →This is the only study on the registry with Mosie Baby as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
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
The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
Pregnancy Rate
The study will measure whether using the Mosie Baby Kit for insemination will result in 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.
Cycle in Which Pregnancy Was Reported
The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test.
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.
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.
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
The study will examine the perceived ease of use of 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.
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.
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
The study will examine whether the user's used the Mosie Kit as described in the instructions and 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
The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety.
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.
Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status
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.
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.
Comparison of Pregnancy Rate Based on Known Fertility Issue
The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue 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.
Insemination Schedule's Impact on Pregnancy
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.
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.
Effect of COVID on Family Expansion
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.
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).
Pregnancy Outcomes 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.
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).
A retrospective study of people who had purchased the Mosie Kit between October 2019 and July 2020 was conducted to understand the efficacy, safety and usability of the at-home insemination kit. Participants were recruited in August 2020 via emailed invitation.
| Milestone | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|
| Started | 272 | 70 | 8 |
| Completed | 272 | 70 | 8 |
| Not completed | 0 | 0 | 0 |
The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Number of Participants Achieving Pregnancy | 99 | 71 | 24 | 4 |
| Number of Participants Not Getting Pregnant | 251 | 201 | 46 | 4 |
The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test.
| Participants | Pregnancies | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| 1 cycle resulted in a pregnancy | 60 | 46 | 12 | 2 |
| 2 cycles resulted in a pregnancy | 18 | 12 | 5 | 1 |
| 3 cycles resulted in a pregnancy | 13 | 9 | 4 | 0 |
| 4 cycles resulted in a pregnancy | 1 | 1 | 0 | 0 |
| 5 cycles resulted in a pregnancy | 0 | 0 | 0 | 0 |
| 6 cycles resulted in a pregnancy | 4 | 2 | 1 | 1 |
| 6+ cycles resulted in a pregnancy | 3 | 1 | 2 | 0 |
The study will measure the difference in pregnancy rates of Mosie Baby Kit users with known fertility issues and those without known fertility issues.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Participants with no fertility issue who got pregnant | 69 | 44 | 21 | 4 |
| Participants with no fertility issue who did not get pregnant | 134 | 89 | 42 | 3 |
| Participants with a fertility issues who got pregnant | 31 | 27 | 3 | 1 |
| Participants with a fertility issues who did not get pregnant | 116 | 112 | 4 | 0 |
The study will examine the perceived ease of use of the Mosie Kit.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Easy Process Overall — Strongly Disagree | 0 | 0 | 0 | 0 |
| Easy Process Overall — Disagree | 2 | 0 | 2 | 0 |
| Easy Process Overall — Neutral | 7 | 6 | 1 | 0 |
| Easy Process Overall — Agree | 101 | 85 | 14 | 2 |
| Easy Process Overall — Strongly Agree | 240 | 181 | 53 | 6 |
| Intuitive Process — Strongly Disagree | 0 | 0 | 0 | 0 |
| Intuitive Process — Disagree | 13 | 10 | 3 | 0 |
| Intuitive Process — Neutral | 19 | 18 | 0 | 1 |
| Intuitive Process — Agree | 121 | 100 | 18 | 3 |
| Intuitive Process — Strongly Agree | 197 | 144 | 49 | 4 |
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.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Easy Sample Collection — Very Difficult | 3 | 1 | 2 | 0 |
| Easy Sample Collection — Difficult | 16 | 15 | 1 | 0 |
| Easy Sample Collection — Neutral | 32 | 18 | 11 | 3 |
| Easy Sample Collection — Easy | 112 | 90 | 21 | 1 |
| Easy Sample Collection — Very Easy | 187 | 148 | 35 | 4 |
| Draw up Semen — Very Difficult | 2 | 0 | 2 | 0 |
| Draw up Semen — Difficult | 7 | 3 | 4 | 0 |
| Draw up Semen — Neutral | 31 | 23 | 7 | 1 |
| Draw up Semen — Easy | 128 | 104 | 23 | 1 |
| Draw up Semen — Very Easy | 182 | 142 | 34 | 6 |
| Insert Syringe — Very Difficult | 0 | 0 | 0 | 0 |
| Insert Syringe — Difficult | 2 | 1 | 1 | 0 |
| Insert Syringe — Neutral | 8 | 7 | 0 | 1 |
| Insert Syringe — Easy | 108 | 91 | 16 | 1 |
| Insert Syringe — Very Easy | 232 | 173 | 53 | 6 |
| Deposit Sperm — Very Difficult | 0 | 0 | 0 | 0 |
| Deposit Sperm — Difficult | 10 | 7 | 3 | 0 |
| Deposit Sperm — Neutral | 24 | 20 | 3 | 1 |
| Deposit Sperm — Easy | 105 | 87 | 17 | 1 |
| Deposit Sperm — Very Easy | 211 | 158 | 47 | 6 |
The study will examine whether the user's used the Mosie Kit as described in the instructions and as intended.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Read instructions | 333 | 258 | 67 | 8 |
| Prepared items | 333 | 256 | 69 | 8 |
| Washed my hands | 324 | 251 | 65 | 8 |
| Tested syringe | 305 | 234 | 63 | 8 |
| Partner washed hands | 288 | 225 | 59 | 4 |
The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Strongly Disgree | 0 | 0 | 0 | 0 |
| Disagree | 1 | 1 | 0 | 0 |
| Neutral | 2 | 2 | 0 | 0 |
| Agree | 95 | 80 | 13 | 2 |
| Strongly Agree | 252 | 189 | 57 | 6 |
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.
| Participants | All Pregnant Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Pregnancies to participants with Issues of Female Origin | 25 | 20 | 3 | 2 |
| Pregnancies to participants with Issues of Male origin | 11 | 8 | 3 | 0 |
| Pregnancies to participants No infertility Issue | 59 | 39 | 18 | 2 |
| Pregnancies to participantsBoth Male and Female Infertility Issue | 4 | 4 | 0 | 0 |
The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue reported.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| PCOS | 12 | 8 | 3 | 1 |
| Endometriosis Low AMH or low ovarian reserve | 4 | 4 | 0 | 0 |
| Vaginismus or vulvodynia | 6 | 6 | 0 | 0 |
| Tilted Uterus | 4 | 4 | 0 | 0 |
| Low Sperm Count | 6 | 5 | 1 | 0 |
| Sperm motility issues | 4 | 4 | 0 | 0 |
| Erectile Dysfunction | 5 | 5 | 0 | 0 |
| Performance issues or sexual anxiety, or inability to orgasm with partner | 14 | 14 | 0 | 0 |
| Unexplained infertility | 10 | 9 | 0 | 0 |
| No fertility issues reported | 51 | 32 | 17 | 2 |
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.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| 1st cycle : at least 2 inseminations per cycle | 52 | 30 | 10 | 2 |
| 1st cycle not meeting criteria | 47 | 41 | 14 | 2 |
| 1st cycle not reporting | 0 | 0 | 0 | 0 |
| 2nd cycles : at least 2 inseminations per cycle | 18 | 13 | 4 | 1 |
| 2nd cycle not meeting criteria | 24 | 16 | 6 | 2 |
| 2nd cycle not reporting | 57 | 42 | 14 | 1 |
| 3rd cycles : at least 2 inseminations per cycle | 5 | 4 | 1 | 0 |
| 3rd cycle not reporting | 83 | 62 | 18 | 3 |
| 3rd cycle not meeting criteria | 11 | 5 | 5 | 1 |
| 4th cycles : at least 2 inseminations per cycle | 4 | 4 | 0 | 0 |
| 4th cycle not meeting criteria | 2 | 1 | 0 | 1 |
| 4th cycle not reporting | 93 | 66 | 24 | 3 |
| 5th cycles : at least 2 inseminations per cycle | 0 | 0 | 0 | 0 |
| 5th cycle not meeting criteria | 0 | 0 | 0 | 0 |
| 5th cycle not reporting | 99 | 71 | 24 | 4 |
| 6th cycles : at least 2 inseminations per cycle | 1 | 0 | 0 | 1 |
| 6th cycle not meeting criteria | 0 | 0 | 0 | 0 |
| 6th cycle not reporting | 98 | 71 | 24 | 3 |
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.
| Participants | All Participants | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Yes | 89 | 67 | 22 | 0 |
| No | 261 | 205 | 48 | 8 |
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.
| Participants | Pregnancies | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent |
|---|---|---|---|---|
| Conception: September 2019 Birth: June 2020 | 1 | 0 | 1 | 0 |
| Conception: October 2019 Birth: July 2020 | 3 | 2 | 1 | 0 |
| Conception: November 2019 Birth: August 2020 | 5 | 2 | 3 | 0 |
| Conception: December 2019 Birth: August 2020 | 4 | 3 | 0 | 1 |
| Conception: January 2020 Birth: September 2021 | 3 | 2 | 1 | 0 |
| Conception: February 2020 Birth: November 2021 | 10 | 5 | 5 | 0 |
| Conception: March 2020 Birth: December 2021 | 7 | 5 | 2 | 0 |
| Conception: April 2020 Birth: Jan 2021 | 16 | 12 | 2 | 2 |
| Conception: May 2020 Birth: Feb 2021 | 11 | 8 | 3 | 0 |
| Conception: June 2020 Birth: March 2021 | 19 | 14 | 5 | 0 |
| Conception: July 2020 Birth: April 2021 | 17 | 15 | 1 | 1 |
| Conception: August 2020 Birth: May 2021 | 2 | 2 | 0 | 0 |
| Unknown | 1 | 1 | 0 | 0 |
Collected over No adverse events were reported specifically for this retrospective study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | — | — |
| Age, Customized(Participants) | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent | Total |
|---|---|---|---|---|
| 20-24 years old | 6 | 5 | 0 | 11 |
| 25-29 years old | 39 | 20 | 1 | 60 |
| 30-34 years old | 83 | 30 | 2 | 115 |
| 35-39 years old | 100 | 10 | 3 | 113 |
| 40-45 years old | 41 | 5 | 1 | 47 |
| 45-50 years old | 4 | 0 | 0 | 4 |
| Sex/Gender, Customized(Participants) | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent | Total |
|---|---|---|---|---|
| Female | 255 | 65 | 8 | 328 |
| Male | 17 | 0 | 0 | 17 |
| Non-binary (female) | 0 | 2 | 0 | 2 |
| Transgender (female) | 0 | 2 | 0 | 2 |
| Transgender (male) | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 14 | 0 | 0 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 25 | 11 | 0 | 36 |
| White | 178 | 35 | 5 | 218 |
| More than one race | 16 | 14 | 2 | 32 |
| Unknown or Not Reported | 39 | 10 | 1 | 50 |
| Region of Enrollment(Participants) | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent | Total |
|---|---|---|---|---|
| United States | 272 | 70 | 8 | 350 |
| Cycles Analyzed(Participants) | Heterosexual Females With a Male Partner | Females in LGBTQ Relationships | Solo Parent | Total |
|---|---|---|---|---|
| 1 Cycle | 98 | 39 | 4 | 141 |
| 2 cycles | 88 | 14 | 2 | 104 |
| 3 cycles | 53 | 8 | 0 | 61 |
| 4 cycles | 16 | 4 | 0 | 20 |
| 5 cycles | 13 | 3 | 0 | 16 |
| 6 cycles | 4 | 2 | 2 | 8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Currently there is no plan to share data.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.