Infertility, Infertility, Female, Infertility, Male
Conditions
Keywords
Insemination, Infertility, Pregnancy
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.
Detailed description
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.
Interventions
DEVICEInsemination with the Mosie Baby Kit
The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
Sponsors
Mosie Baby
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 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 | 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. |
| Cycle in Which Pregnancy Was 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. | The outcome measure is the number of cycles of Mosie use which resulted in a positive pregnancy test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | The study will examine the perceived ease of use of the Mosie Kit. |
| 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. | The study will examine whether the user's used the Mosie Kit as described in the instructions and as intended. |
| 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. | The study will examine the user's perceived safety of using the Mosie Kit syringe by evaluating overall perceived safety. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | The study will examine the resulting pregnancy rates of users in comparison to the type of infertility issue reported. |
| Pregnancy Outcomes During COVID | 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). | 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. |
| Effect of COVID on Family Expansion | 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). | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 272 |
| 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. | 70 |
| 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. | 8 |
| Total | 350 |
Baseline characteristics
| Characteristic | Females in LGBTQ Relationships | Solo Parent | Heterosexual Females With a Male Partner | Total |
|---|---|---|---|---|
| Age, Customized 20-24 years old | 5 Participants | 0 Participants | 6 Participants | 11 Participants |
| Age, Customized 25-29 years old | 20 Participants | 1 Participants | 39 Participants | 60 Participants |
| Age, Customized 30-34 years old | 30 Participants | 2 Participants | 83 Participants | 115 Participants |
| Age, Customized 35-39 years old | 10 Participants | 3 Participants | 100 Participants | 113 Participants |
| Age, Customized 40-45 years old | 5 Participants | 1 Participants | 41 Participants | 47 Participants |
| Age, Customized 45-50 years old | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Cycles Analyzed 1 Cycle | 39 Participants | 4 Participants | 98 Participants | 141 Participants |
| Cycles Analyzed 2 cycles | 14 Participants | 2 Participants | 88 Participants | 104 Participants |
| Cycles Analyzed 3 cycles | 8 Participants | 0 Participants | 53 Participants | 61 Participants |
| Cycles Analyzed 4 cycles | 4 Participants | 0 Participants | 16 Participants | 20 Participants |
| Cycles Analyzed 5 cycles | 3 Participants | 0 Participants | 13 Participants | 16 Participants |
| Cycles Analyzed 6 cycles | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 14 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 0 Participants | 25 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 2 Participants | 16 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 1 Participants | 39 Participants | 50 Participants |
| Race (NIH/OMB) White | 35 Participants | 5 Participants | 178 Participants | 218 Participants |
| Region of Enrollment United States | 70 Participants | 8 Participants | 272 Participants | 350 Participants |
| Sex/Gender, Customized Female | 65 Participants | 8 Participants | 255 Participants | 328 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 17 Participants | 17 Participants |
| Sex/Gender, Customized Non-binary (female) | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Transgender (female) | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Transgender (male) | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Cycle in Which Pregnancy Was Reported | 2 cycles resulted in a pregnancy | 18 Participants |
| All Participants | Cycle in Which Pregnancy Was Reported | 6 cycles resulted in a pregnancy | 4 Participants |
| All Participants | Cycle in Which Pregnancy Was Reported | 5 cycles resulted in a pregnancy | 0 Participants |
| All Participants | Cycle in Which Pregnancy Was Reported | 6+ cycles resulted in a pregnancy | 3 Participants |
| All Participants | Cycle in Which Pregnancy Was Reported | 3 cycles resulted in a pregnancy | 13 Participants |
| All Participants | Cycle in Which Pregnancy Was Reported | 1 cycle resulted in a pregnancy | 60 Participants |
| All Participants | Cycle in Which Pregnancy Was Reported | 4 cycles resulted in a pregnancy | 1 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 4 cycles resulted in a pregnancy | 1 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 6 cycles resulted in a pregnancy | 2 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 3 cycles resulted in a pregnancy | 9 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 5 cycles resulted in a pregnancy | 0 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 6+ cycles resulted in a pregnancy | 1 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 2 cycles resulted in a pregnancy | 12 Participants |
| Heterosexual Females With a Male Partner | Cycle in Which Pregnancy Was Reported | 1 cycle resulted in a pregnancy | 46 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 4 cycles resulted in a pregnancy | 0 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 1 cycle resulted in a pregnancy | 12 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 2 cycles resulted in a pregnancy | 5 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 3 cycles resulted in a pregnancy | 4 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 5 cycles resulted in a pregnancy | 0 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 6 cycles resulted in a pregnancy | 1 Participants |
| Females in LGBTQ Relationships | Cycle in Which Pregnancy Was Reported | 6+ cycles resulted in a pregnancy | 2 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 3 cycles resulted in a pregnancy | 0 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 6+ cycles resulted in a pregnancy | 0 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 6 cycles resulted in a pregnancy | 1 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 2 cycles resulted in a pregnancy | 1 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 1 cycle resulted in a pregnancy | 2 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 5 cycles resulted in a pregnancy | 0 Participants |
| Solo Parent | Cycle in Which Pregnancy Was Reported | 4 cycles resulted in a pregnancy | 0 Participants |
Primary
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Pregnancy Rate | Number of Participants Achieving Pregnancy | 99 Participants |
| All Participants | Pregnancy Rate | Number of Participants Not Getting Pregnant | 251 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate | Number of Participants Not Getting Pregnant | 201 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate | Number of Participants Achieving Pregnancy | 71 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate | Number of Participants Achieving Pregnancy | 24 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate | Number of Participants Not Getting Pregnant | 46 Participants |
| Solo Parent | Pregnancy Rate | Number of Participants Achieving Pregnancy | 4 Participants |
| Solo Parent | Pregnancy Rate | Number of Participants Not Getting Pregnant | 4 Participants |
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.
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.
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who got pregnant | 69 Participants |
| All Participants | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who did not get pregnant | 134 Participants |
| All Participants | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who got pregnant | 31 Participants |
| All Participants | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who did not get pregnant | 116 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who did not get pregnant | 89 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who got pregnant | 27 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who did not get pregnant | 112 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who got pregnant | 44 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who got pregnant | 3 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who did not get pregnant | 42 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who did not get pregnant | 4 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who got pregnant | 21 Participants |
| Solo Parent | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who did not get pregnant | 0 Participants |
| Solo Parent | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who did not get pregnant | 3 Participants |
| Solo Parent | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with no fertility issue who got pregnant | 4 Participants |
| Solo Parent | Pregnancy Rate Differences Between Couples With Fertility Issues and Without | Participants with a fertility issues who got pregnant | 1 Participants |
Secondary
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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Ease of Use | Intuitive Process | Strongly Disagree | 0 Participants |
| All Participants | Ease of Use | Easy Process Overall | Neutral | 7 Participants |
| All Participants | Ease of Use | Intuitive Process | Strongly Agree | 197 Participants |
| All Participants | Ease of Use | Easy Process Overall | Strongly Agree | 240 Participants |
| All Participants | Ease of Use | Easy Process Overall | Agree | 101 Participants |
| All Participants | Ease of Use | Intuitive Process | Agree | 121 Participants |
| All Participants | Ease of Use | Intuitive Process | Neutral | 19 Participants |
| All Participants | Ease of Use | Easy Process Overall | Disagree | 2 Participants |
| All Participants | Ease of Use | Easy Process Overall | Strongly Disagree | 0 Participants |
| All Participants | Ease of Use | Intuitive Process | Disagree | 13 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Easy Process Overall | Strongly Agree | 181 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Intuitive Process | Strongly Agree | 144 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Easy Process Overall | Strongly Disagree | 0 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Easy Process Overall | Disagree | 0 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Easy Process Overall | Neutral | 6 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Easy Process Overall | Agree | 85 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Intuitive Process | Strongly Disagree | 0 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Intuitive Process | Disagree | 10 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Intuitive Process | Neutral | 18 Participants |
| Heterosexual Females With a Male Partner | Ease of Use | Intuitive Process | Agree | 100 Participants |
| Females in LGBTQ Relationships | Ease of Use | Intuitive Process | Strongly Agree | 49 Participants |
| Females in LGBTQ Relationships | Ease of Use | Easy Process Overall | Strongly Agree | 53 Participants |
| Females in LGBTQ Relationships | Ease of Use | Intuitive Process | Strongly Disagree | 0 Participants |
| Females in LGBTQ Relationships | Ease of Use | Easy Process Overall | Disagree | 2 Participants |
| Females in LGBTQ Relationships | Ease of Use | Intuitive Process | Agree | 18 Participants |
| Females in LGBTQ Relationships | Ease of Use | Intuitive Process | Disagree | 3 Participants |
| Females in LGBTQ Relationships | Ease of Use | Intuitive Process | Neutral | 0 Participants |
| Females in LGBTQ Relationships | Ease of Use | Easy Process Overall | Strongly Disagree | 0 Participants |
| Females in LGBTQ Relationships | Ease of Use | Easy Process Overall | Agree | 14 Participants |
| Females in LGBTQ Relationships | Ease of Use | Easy Process Overall | Neutral | 1 Participants |
| Solo Parent | Ease of Use | Intuitive Process | Disagree | 0 Participants |
| Solo Parent | Ease of Use | Easy Process Overall | Strongly Disagree | 0 Participants |
| Solo Parent | Ease of Use | Easy Process Overall | Strongly Agree | 6 Participants |
| Solo Parent | Ease of Use | Easy Process Overall | Disagree | 0 Participants |
| Solo Parent | Ease of Use | Intuitive Process | Strongly Agree | 4 Participants |
| Solo Parent | Ease of Use | Intuitive Process | Agree | 3 Participants |
| Solo Parent | Ease of Use | Intuitive Process | Strongly Disagree | 0 Participants |
| Solo Parent | Ease of Use | Easy Process Overall | Agree | 2 Participants |
| Solo Parent | Ease of Use | Intuitive Process | Neutral | 1 Participants |
| Solo Parent | Ease of Use | Easy Process Overall | Neutral | 0 Participants |
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.
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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Ease of Use: Usage Steps | Deposit Sperm | Very Easy | 211 Participants |
| All Participants | Ease of Use: Usage Steps | Deposit Sperm | Neutral | 24 Participants |
| All Participants | Ease of Use: Usage Steps | Draw up Semen | Very Difficult | 2 Participants |
| All Participants | Ease of Use: Usage Steps | Insert Syringe | Very Difficult | 0 Participants |
| All Participants | Ease of Use: Usage Steps | Easy Sample Collection | Difficult | 16 Participants |
| All Participants | Ease of Use: Usage Steps | Insert Syringe | Neutral | 8 Participants |
| All Participants | Ease of Use: Usage Steps | Draw up Semen | Difficult | 7 Participants |
| All Participants | Ease of Use: Usage Steps | Deposit Sperm | Easy | 105 Participants |
| All Participants | Ease of Use: Usage Steps | Easy Sample Collection | Easy | 112 Participants |
| All Participants | Ease of Use: Usage Steps | Deposit Sperm | Difficult | 10 Participants |
| All Participants | Ease of Use: Usage Steps | Draw up Semen | Neutral | 31 Participants |
| All Participants | Ease of Use: Usage Steps | Insert Syringe | Very Easy | 232 Participants |
| All Participants | Ease of Use: Usage Steps | Easy Sample Collection | Very Difficult | 3 Participants |
| All Participants | Ease of Use: Usage Steps | Insert Syringe | Difficult | 2 Participants |
| All Participants | Ease of Use: Usage Steps | Draw up Semen | Easy | 128 Participants |
| All Participants | Ease of Use: Usage Steps | Easy Sample Collection | Neutral | 32 Participants |
| All Participants | Ease of Use: Usage Steps | Easy Sample Collection | Very Easy | 187 Participants |
| All Participants | Ease of Use: Usage Steps | Deposit Sperm | Very Difficult | 0 Participants |
| All Participants | Ease of Use: Usage Steps | Draw up Semen | Very Easy | 182 Participants |
| All Participants | Ease of Use: Usage Steps | Insert Syringe | Easy | 108 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Insert Syringe | Easy | 91 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Insert Syringe | Very Difficult | 0 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Easy Sample Collection | Neutral | 18 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Insert Syringe | Neutral | 7 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Insert Syringe | Difficult | 1 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Insert Syringe | Very Easy | 173 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Easy Sample Collection | Very Difficult | 1 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Easy Sample Collection | Easy | 90 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Deposit Sperm | Very Easy | 158 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Deposit Sperm | Neutral | 20 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Easy Sample Collection | Very Easy | 148 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Draw up Semen | Very Difficult | 0 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Deposit Sperm | Difficult | 7 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Draw up Semen | Difficult | 3 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Easy Sample Collection | Difficult | 15 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Draw up Semen | Neutral | 23 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Deposit Sperm | Very Difficult | 0 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Draw up Semen | Easy | 104 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Deposit Sperm | Easy | 87 Participants |
| Heterosexual Females With a Male Partner | Ease of Use: Usage Steps | Draw up Semen | Very Easy | 142 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Easy Sample Collection | Very Easy | 35 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Easy Sample Collection | Very Difficult | 2 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Easy Sample Collection | Difficult | 1 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Easy Sample Collection | Neutral | 11 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Easy Sample Collection | Easy | 21 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Insert Syringe | Easy | 16 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Draw up Semen | Very Difficult | 2 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Draw up Semen | Difficult | 4 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Draw up Semen | Neutral | 7 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Draw up Semen | Easy | 23 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Draw up Semen | Very Easy | 34 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Insert Syringe | Very Difficult | 0 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Insert Syringe | Difficult | 1 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Insert Syringe | Neutral | 0 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Insert Syringe | Very Easy | 53 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Deposit Sperm | Very Difficult | 0 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Deposit Sperm | Difficult | 3 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Deposit Sperm | Neutral | 3 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Deposit Sperm | Easy | 17 Participants |
| Females in LGBTQ Relationships | Ease of Use: Usage Steps | Deposit Sperm | Very Easy | 47 Participants |
| Solo Parent | Ease of Use: Usage Steps | Draw up Semen | Easy | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Draw up Semen | Neutral | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Deposit Sperm | Easy | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Deposit Sperm | Very Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Draw up Semen | Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Draw up Semen | Very Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Easy Sample Collection | Very Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Deposit Sperm | Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Easy Sample Collection | Very Easy | 4 Participants |
| Solo Parent | Ease of Use: Usage Steps | Easy Sample Collection | Easy | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Insert Syringe | Easy | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Deposit Sperm | Neutral | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Easy Sample Collection | Neutral | 3 Participants |
| Solo Parent | Ease of Use: Usage Steps | Insert Syringe | Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Insert Syringe | Very Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Easy Sample Collection | Difficult | 0 Participants |
| Solo Parent | Ease of Use: Usage Steps | Insert Syringe | Neutral | 1 Participants |
| Solo Parent | Ease of Use: Usage Steps | Draw up Semen | Very Easy | 6 Participants |
| Solo Parent | Ease of Use: Usage Steps | Deposit Sperm | Very Easy | 6 Participants |
| Solo Parent | Ease of Use: Usage Steps | Insert Syringe | Very Easy | 6 Participants |
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.
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Perceived Safety of Using the Mosie Kit | Disagree | 1 Participants |
| All Participants | Perceived Safety of Using the Mosie Kit | Strongly Disgree | 0 Participants |
| All Participants | Perceived Safety of Using the Mosie Kit | Strongly Agree | 252 Participants |
| All Participants | Perceived Safety of Using the Mosie Kit | Neutral | 2 Participants |
| All Participants | Perceived Safety of Using the Mosie Kit | Agree | 95 Participants |
| Heterosexual Females With a Male Partner | Perceived Safety of Using the Mosie Kit | Neutral | 2 Participants |
| Heterosexual Females With a Male Partner | Perceived Safety of Using the Mosie Kit | Agree | 80 Participants |
| Heterosexual Females With a Male Partner | Perceived Safety of Using the Mosie Kit | Strongly Agree | 189 Participants |
| Heterosexual Females With a Male Partner | Perceived Safety of Using the Mosie Kit | Disagree | 1 Participants |
| Heterosexual Females With a Male Partner | Perceived Safety of Using the Mosie Kit | Strongly Disgree | 0 Participants |
| Females in LGBTQ Relationships | Perceived Safety of Using the Mosie Kit | Disagree | 0 Participants |
| Females in LGBTQ Relationships | Perceived Safety of Using the Mosie Kit | Strongly Disgree | 0 Participants |
| Females in LGBTQ Relationships | Perceived Safety of Using the Mosie Kit | Neutral | 0 Participants |
| Females in LGBTQ Relationships | Perceived Safety of Using the Mosie Kit | Agree | 13 Participants |
| Females in LGBTQ Relationships | Perceived Safety of Using the Mosie Kit | Strongly Agree | 57 Participants |
| Solo Parent | Perceived Safety of Using the Mosie Kit | Agree | 2 Participants |
| Solo Parent | Perceived Safety of Using the Mosie Kit | Disagree | 0 Participants |
| Solo Parent | Perceived Safety of Using the Mosie Kit | Strongly Disgree | 0 Participants |
| Solo Parent | Perceived Safety of Using the Mosie Kit | Neutral | 0 Participants |
| Solo Parent | Perceived Safety of Using the Mosie Kit | Strongly Agree | 6 Participants |
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.
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Use of the Kit as Intended | Tested syringe | 305 Participants |
| All Participants | Use of the Kit as Intended | Prepared items | 333 Participants |
| All Participants | Use of the Kit as Intended | Partner washed hands | 288 Participants |
| All Participants | Use of the Kit as Intended | Washed my hands | 324 Participants |
| All Participants | Use of the Kit as Intended | Read instructions | 333 Participants |
| Heterosexual Females With a Male Partner | Use of the Kit as Intended | Washed my hands | 251 Participants |
| Heterosexual Females With a Male Partner | Use of the Kit as Intended | Tested syringe | 234 Participants |
| Heterosexual Females With a Male Partner | Use of the Kit as Intended | Partner washed hands | 225 Participants |
| Heterosexual Females With a Male Partner | Use of the Kit as Intended | Prepared items | 256 Participants |
| Heterosexual Females With a Male Partner | Use of the Kit as Intended | Read instructions | 258 Participants |
| Females in LGBTQ Relationships | Use of the Kit as Intended | Washed my hands | 65 Participants |
| Females in LGBTQ Relationships | Use of the Kit as Intended | Read instructions | 67 Participants |
| Females in LGBTQ Relationships | Use of the Kit as Intended | Prepared items | 69 Participants |
| Females in LGBTQ Relationships | Use of the Kit as Intended | Tested syringe | 63 Participants |
| Females in LGBTQ Relationships | Use of the Kit as Intended | Partner washed hands | 59 Participants |
| Solo Parent | Use of the Kit as Intended | Tested syringe | 8 Participants |
| Solo Parent | Use of the Kit as Intended | Prepared items | 8 Participants |
| Solo Parent | Use of the Kit as Intended | Read instructions | 8 Participants |
| Solo Parent | Use of the Kit as Intended | Washed my hands | 8 Participants |
| Solo Parent | Use of the Kit as Intended | Partner washed hands | 4 Participants |
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.
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.
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Vaginismus or vulvodynia | 6 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Sperm motility issues | 4 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Erectile Dysfunction | 5 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | No fertility issues reported | 51 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Endometriosis Low AMH or low ovarian reserve | 4 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Unexplained infertility | 10 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | PCOS | 12 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Tilted Uterus | 4 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Performance issues or sexual anxiety, or inability to orgasm with partner | 14 Participants |
| All Participants | Comparison of Pregnancy Rate Based on Known Fertility Issue | Low Sperm Count | 6 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Tilted Uterus | 4 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Erectile Dysfunction | 5 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Unexplained infertility | 9 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Sperm motility issues | 4 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | No fertility issues reported | 32 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | PCOS | 8 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Performance issues or sexual anxiety, or inability to orgasm with partner | 14 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Low Sperm Count | 5 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Endometriosis Low AMH or low ovarian reserve | 4 Participants |
| Heterosexual Females With a Male Partner | Comparison of Pregnancy Rate Based on Known Fertility Issue | Vaginismus or vulvodynia | 6 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Low Sperm Count | 1 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | PCOS | 3 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Endometriosis Low AMH or low ovarian reserve | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Vaginismus or vulvodynia | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Tilted Uterus | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Sperm motility issues | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Erectile Dysfunction | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Performance issues or sexual anxiety, or inability to orgasm with partner | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | Unexplained infertility | 0 Participants |
| Females in LGBTQ Relationships | Comparison of Pregnancy Rate Based on Known Fertility Issue | No fertility issues reported | 17 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Tilted Uterus | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Vaginismus or vulvodynia | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Performance issues or sexual anxiety, or inability to orgasm with partner | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Endometriosis Low AMH or low ovarian reserve | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | No fertility issues reported | 2 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Unexplained infertility | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Sperm motility issues | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Low Sperm Count | 0 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | PCOS | 1 Participants |
| Solo Parent | Comparison of Pregnancy Rate Based on Known Fertility Issue | Erectile Dysfunction | 0 Participants |
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.
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Effect of COVID on Family Expansion | No | 261 Participants |
| All Participants | Effect of COVID on Family Expansion | Yes | 89 Participants |
| Heterosexual Females With a Male Partner | Effect of COVID on Family Expansion | No | 205 Participants |
| Heterosexual Females With a Male Partner | Effect of COVID on Family Expansion | Yes | 67 Participants |
| Females in LGBTQ Relationships | Effect of COVID on Family Expansion | Yes | 22 Participants |
| Females in LGBTQ Relationships | Effect of COVID on Family Expansion | No | 48 Participants |
| Solo Parent | Effect of COVID on Family Expansion | Yes | 0 Participants |
| Solo Parent | Effect of COVID on Family Expansion | No | 8 Participants |
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.
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.
Population: Only participants who ended up pregnant are included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Insemination Schedule's Impact on Pregnancy | 1st cycle not reporting | 0 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 5th cycle not reporting | 99 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 4th cycles : at least 2 inseminations per cycle | 4 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 4th cycle not meeting criteria | 2 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 1st cycle : at least 2 inseminations per cycle | 52 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 5th cycle not meeting criteria | 0 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 4th cycle not reporting | 93 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 5th cycles : at least 2 inseminations per cycle | 0 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 2nd cycles : at least 2 inseminations per cycle | 18 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 6th cycle not meeting criteria | 0 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 2nd cycle not meeting criteria | 24 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 1st cycle not meeting criteria | 47 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 2nd cycle not reporting | 57 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 3rd cycles : at least 2 inseminations per cycle | 5 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 6th cycles : at least 2 inseminations per cycle | 1 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 3rd cycle not reporting | 83 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 6th cycle not reporting | 98 Participants |
| All Participants | Insemination Schedule's Impact on Pregnancy | 3rd cycle not meeting criteria | 11 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 1st cycle : at least 2 inseminations per cycle | 30 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 2nd cycle not meeting criteria | 16 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 3rd cycle not meeting criteria | 5 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 4th cycles : at least 2 inseminations per cycle | 4 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 1st cycle not reporting | 0 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 5th cycle not meeting criteria | 0 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 4th cycle not reporting | 66 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 4th cycle not meeting criteria | 1 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 5th cycle not reporting | 71 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 2nd cycle not reporting | 42 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 1st cycle not meeting criteria | 41 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 5th cycles : at least 2 inseminations per cycle | 0 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 6th cycles : at least 2 inseminations per cycle | 0 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 6th cycle not meeting criteria | 0 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 3rd cycle not reporting | 62 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 2nd cycles : at least 2 inseminations per cycle | 13 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 6th cycle not reporting | 71 Participants |
| Heterosexual Females With a Male Partner | Insemination Schedule's Impact on Pregnancy | 3rd cycles : at least 2 inseminations per cycle | 4 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 6th cycles : at least 2 inseminations per cycle | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 4th cycle not reporting | 24 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 1st cycle : at least 2 inseminations per cycle | 10 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 1st cycle not meeting criteria | 14 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 1st cycle not reporting | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 2nd cycles : at least 2 inseminations per cycle | 4 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 2nd cycle not meeting criteria | 6 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 2nd cycle not reporting | 14 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 3rd cycles : at least 2 inseminations per cycle | 1 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 3rd cycle not reporting | 18 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 3rd cycle not meeting criteria | 5 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 4th cycles : at least 2 inseminations per cycle | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 4th cycle not meeting criteria | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 5th cycles : at least 2 inseminations per cycle | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 5th cycle not meeting criteria | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 5th cycle not reporting | 24 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 6th cycle not meeting criteria | 0 Participants |
| Females in LGBTQ Relationships | Insemination Schedule's Impact on Pregnancy | 6th cycle not reporting | 24 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 1st cycle not meeting criteria | 2 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 5th cycle not meeting criteria | 0 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 3rd cycle not meeting criteria | 1 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 3rd cycle not reporting | 3 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 1st cycle : at least 2 inseminations per cycle | 2 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 5th cycle not reporting | 4 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 3rd cycles : at least 2 inseminations per cycle | 0 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 2nd cycle not reporting | 1 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 2nd cycle not meeting criteria | 2 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 6th cycles : at least 2 inseminations per cycle | 1 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 2nd cycles : at least 2 inseminations per cycle | 1 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 1st cycle not reporting | 0 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 6th cycle not reporting | 3 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 4th cycle not reporting | 3 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 6th cycle not meeting criteria | 0 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 5th cycles : at least 2 inseminations per cycle | 0 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 4th cycle not meeting criteria | 1 Participants |
| Solo Parent | Insemination Schedule's Impact on Pregnancy | 4th cycles : at least 2 inseminations per cycle | 0 Participants |
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.
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Pregnancy Outcomes During COVID | Conception: September 2019 Birth: June 2020 | 1 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: October 2019 Birth: July 2020 | 3 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: November 2019 Birth: August 2020 | 5 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: December 2019 Birth: August 2020 | 4 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: January 2020 Birth: September 2021 | 3 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: February 2020 Birth: November 2021 | 10 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: March 2020 Birth: December 2021 | 7 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: April 2020 Birth: Jan 2021 | 16 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: May 2020 Birth: Feb 2021 | 11 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: June 2020 Birth: March 2021 | 19 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: July 2020 Birth: April 2021 | 17 Participants |
| All Participants | Pregnancy Outcomes During COVID | Conception: August 2020 Birth: May 2021 | 2 Participants |
| All Participants | Pregnancy Outcomes During COVID | Unknown | 1 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: December 2019 Birth: August 2020 | 3 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Unknown | 1 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: July 2020 Birth: April 2021 | 15 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: April 2020 Birth: Jan 2021 | 12 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: November 2019 Birth: August 2020 | 2 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: September 2019 Birth: June 2020 | 0 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: June 2020 Birth: March 2021 | 14 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: May 2020 Birth: Feb 2021 | 8 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: February 2020 Birth: November 2021 | 5 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: January 2020 Birth: September 2021 | 2 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: October 2019 Birth: July 2020 | 2 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: August 2020 Birth: May 2021 | 2 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Outcomes During COVID | Conception: March 2020 Birth: December 2021 | 5 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: July 2020 Birth: April 2021 | 1 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: December 2019 Birth: August 2020 | 0 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: January 2020 Birth: September 2021 | 1 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Unknown | 0 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: February 2020 Birth: November 2021 | 5 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: March 2020 Birth: December 2021 | 2 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: August 2020 Birth: May 2021 | 0 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: April 2020 Birth: Jan 2021 | 2 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: May 2020 Birth: Feb 2021 | 3 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: June 2020 Birth: March 2021 | 5 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: September 2019 Birth: June 2020 | 1 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: October 2019 Birth: July 2020 | 1 Participants |
| Females in LGBTQ Relationships | Pregnancy Outcomes During COVID | Conception: November 2019 Birth: August 2020 | 3 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: June 2020 Birth: March 2021 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: April 2020 Birth: Jan 2021 | 2 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: December 2019 Birth: August 2020 | 1 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: September 2019 Birth: June 2020 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: March 2020 Birth: December 2021 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: February 2020 Birth: November 2021 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: November 2019 Birth: August 2020 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: October 2019 Birth: July 2020 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: January 2020 Birth: September 2021 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: May 2020 Birth: Feb 2021 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Unknown | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: August 2020 Birth: May 2021 | 0 Participants |
| Solo Parent | Pregnancy Outcomes During COVID | Conception: July 2020 Birth: April 2021 | 1 Participants |
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.
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Female Origin | 25 Participants |
| All Participants | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participantsBoth Male and Female Infertility Issue | 4 Participants |
| All Participants | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants No infertility Issue | 59 Participants |
| All Participants | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Male origin | 11 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Male origin | 8 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants No infertility Issue | 39 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Female Origin | 20 Participants |
| Heterosexual Females With a Male Partner | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participantsBoth Male and Female Infertility Issue | 4 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Male origin | 3 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Female Origin | 3 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants No infertility Issue | 18 Participants |
| Females in LGBTQ Relationships | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participantsBoth Male and Female Infertility Issue | 0 Participants |
| Solo Parent | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Female Origin | 2 Participants |
| Solo Parent | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants with Issues of Male origin | 0 Participants |
| Solo Parent | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participantsBoth Male and Female Infertility Issue | 0 Participants |
| Solo Parent | Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status | Pregnancies to participants No infertility Issue | 2 Participants |