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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insemination with the Mosie Baby Kit | Device | The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use | The study will examine the perceived ease of use of 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. |
| Ease of Use: Usage Steps |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karina Loyo, PhD MBA CCDM | Independent Researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtual Study - Online Data Collection | Austin | Texas | 78704 | United States |
Currently there is no plan to share data.
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Subjects who were 18 years old and who had used the at-home Mosie Insemination kit for at least one cycle were included in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| FG001 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| FG002 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pregnancy Rate | The study will measure whether using the Mosie Baby Kit for insemination will result in pregnancy. | Posted | Count of Participants | Participants | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. |
|
No adverse events were reported specifically for this retrospective study.
Adverse events were not collected for this retrospective study. All-cause mortality was not collected and is not recorded for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karina Loyo, Ph.D., MBA, CCDM | Mosie Baby (Consultant) | 512-563-1393 | karina@drkarina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 31, 2020 | Jan 12, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007247 | Infertility, Female |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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). |
| 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| BG002 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participants were allowed to select all that applied from the options which include the categories listed plus Hispanic/LatinX. The other category below reports those that selected only Hispanic/LatinX plus other as a category. The Multiple Race reflects all that selected either multiple race or more than one race or ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cycles Analyzed | Count of Participants | Participants |
|
| OG002 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
| OG003 | 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: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit. |
|
|
| Primary | Cycle in Which Pregnancy Was Reported | The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test. | Posted | Count of Participants | Participants | Up to 6 full menstrual cycles (generally 28 days in length) prior to survey. The number of cycles reported by each participant may vary. |
|
|
|
| Primary | 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. | The number differs because the denominator shows the number of women fitting each of the described criteria. This adjustment is required in order to be able to examine this hypothesis which is based on the rate of each group's pregnancy rate. | Posted | Count of Participants | Participants | 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 | Ease of Use | The study will examine the perceived ease of use of the Mosie Kit. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Count of Participants | Participants | 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 Pre-specified | 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. | Posted | Count of Participants | Participants | 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 Pre-specified | 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. | All participants reporting a pregnancy were asked to indicate as many sources of infertility as desired by marking the options provided. Some participants reported multiple sources for their fertility issue (n=48). Also some participants noted 'No' fertility issue (n=51). The outcome data table shows all conditions available for selection plus a row to capture the participants that indicated no infertility source. Data can only be aggregated across a row; data should not be aggregated by column. | Posted | Count of Participants | Participants | 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 Pre-specified | 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. | Only participants who ended up pregnant are included in this analysis. | Posted | Count of Participants | Participants | 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 Pre-specified | 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. | Posted | Count of Participants | Participants | 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). |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 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). |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| 2 cycles resulted in a pregnancy |
|
| 3 cycles resulted in a pregnancy |
|
| 4 cycles resulted in a pregnancy |
|
| 5 cycles resulted in a pregnancy |
|
| 6 cycles resulted in a pregnancy |
|
| 6+ cycles resulted in a pregnancy |
|
| Participants with no fertility issue who did not get pregnant |
|
| Participants with a fertility issues who got pregnant |
|
| Participants with a fertility issues who did not get pregnant |
|
| Disagree |
|
| Neutral |
|
| Agree |
|
| Strongly Agree |
|
| Intuitive Process |
|
| Difficult |
|
| Neutral |
|
| Easy |
|
| Very Easy |
|
| Draw up Semen |
|
| Insert Syringe |
|
| Deposit Sperm |
|
| Prepared items |
|
| Washed my hands |
|
| Tested syringe |
|
| Partner washed hands |
|
| Disagree |
|
| Neutral |
|
| Agree |
|
| Strongly Agree |
|
| Pregnancies to participants with Issues of Male origin |
|
| Pregnancies to participants No infertility Issue |
|
| Pregnancies to participantsBoth Male and Female Infertility Issue |
|
| Endometriosis Low AMH or low ovarian reserve |
|
| Vaginismus or vulvodynia |
|
| Tilted Uterus |
|
| Low Sperm Count |
|
| Sperm motility issues |
|
| Erectile Dysfunction |
|
| Performance issues or sexual anxiety, or inability to orgasm with partner |
|
| Unexplained infertility |
|
| No fertility issues reported |
|
| 1st cycle not meeting criteria |
|
| 1st cycle not reporting |
|
| 2nd cycles : at least 2 inseminations per cycle |
|
| 2nd cycle not meeting criteria |
|
| 2nd cycle not reporting |
|
| 3rd cycles : at least 2 inseminations per cycle |
|
| 3rd cycle not reporting |
|
| 3rd cycle not meeting criteria |
|
| 4th cycles : at least 2 inseminations per cycle |
|
| 4th cycle not meeting criteria |
|
| 4th cycle not reporting |
|
| 5th cycles : at least 2 inseminations per cycle |
|
| 5th cycle not meeting criteria |
|
| 5th cycle not reporting |
|
| 6th cycles : at least 2 inseminations per cycle |
|
| 6th cycle not meeting criteria |
|
| 6th cycle not reporting |
|
| No |
|
| Conception: October 2019 Birth: July 2020 |
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| Conception: November 2019 Birth: August 2020 |
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| Conception: December 2019 Birth: August 2020 |
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| Conception: January 2020 Birth: September 2021 |
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| Conception: February 2020 Birth: November 2021 |
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| Conception: March 2020 Birth: December 2021 |
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| Conception: April 2020 Birth: Jan 2021 |
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| Conception: May 2020 Birth: Feb 2021 |
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| Conception: June 2020 Birth: March 2021 |
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| Conception: July 2020 Birth: April 2021 |
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| Conception: August 2020 Birth: May 2021 |
|
| Unknown |
|