NCT04646291 is a clinical trial of Insemination with the Mosie Baby Kit in Infertility, sponsored by Mosie Baby.

Who is sponsoring NCT04646291?

NCT04646291 is sponsored by Mosie Baby.

What drugs are being tested in NCT04646291?

Interventions in NCT04646291: Insemination with the Mosie Baby Kit.

What condition does NCT04646291 study?

NCT04646291 studies Infertility, Infertility, Female, Infertility, Male.

Is NCT04646291 still recruiting?

NCT04646291 is currently completed. Last updated 24 June 2021.

Are results published for NCT04646291?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-24 · How we verify

NCT04646291

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 24 June 2021

What this trial tests

trial testing Insemination with the Mosie Baby Kit in Infertility in 350 participants. Completed in 1 September 2020.

Timeline

5 August 2020

Primary endpoint
31 August 2020

1 September 2020

Quick facts

Lead sponsor	Mosie Baby
Status	Completed
Study type	OBSERVATIONAL
Enrollment	350
Start date	5 August 2020
Primary completion	31 August 2020
Estimated completion	1 September 2020
Sites	1 location across United States

Drugs / interventions tested

Insemination with the Mosie Baby Kit

Conditions studied

Infertility — all drugs for Infertility →
Infertility, Female — all drugs for Infertility, Female →
Infertility, Male — all drugs for Infertility, Male →

Sponsor

Mosie Baby

Who can join

Eligibility, any sex, with Infertility or Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pregnancy Rate Primary · 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.

Number of Participants Achieving Pregnancy

Group	Value	95% CI
All Participants	99
Heterosexual Females With a Male Partner	71
Females in LGBTQ Relationships	24
Solo Parent	4

Number of Participants Not Getting Pregnant

Group	Value	95% CI
All Participants	251
Heterosexual Females With a Male Partner	201
Females in LGBTQ Relationships	46
Solo Parent	4

Cycle in Which Pregnancy Was Reported Primary · 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.

1 cycle resulted in a pregnancy

Group	Value	95% CI
Pregnancies	60
Heterosexual Females With a Male Partner	46
Females in LGBTQ Relationships	12
Solo Parent	2

2 cycles resulted in a pregnancy

Group	Value	95% CI
Pregnancies	18
Heterosexual Females With a Male Partner	12
Females in LGBTQ Relationships	5
Solo Parent	1

3 cycles resulted in a pregnancy

Group	Value	95% CI
Pregnancies	13
Heterosexual Females With a Male Partner	9
Females in LGBTQ Relationships	4
Solo Parent	0

4 cycles resulted in a pregnancy

Group	Value	95% CI
Pregnancies	1
Heterosexual Females With a Male Partner	1
Females in LGBTQ Relationships	0
Solo Parent	0

5 cycles resulted in a pregnancy

Group	Value	95% CI
Pregnancies	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0

6 cycles resulted in a pregnancy

Group	Value	95% CI
Pregnancies	4
Heterosexual Females With a Male Partner	2
Females in LGBTQ Relationships	1
Solo Parent	1

6+ cycles resulted in a pregnancy

Group	Value	95% CI
Pregnancies	3
Heterosexual Females With a Male Partner	1
Females in LGBTQ Relationships	2
Solo Parent	0

Pregnancy Rate Differences Between Couples With Fertility Issues and Without Primary · 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.

Participants with no fertility issue who got pregnant

Group	Value	95% CI
All Participants	69
Heterosexual Females With a Male Partner	44
Females in LGBTQ Relationships	21
Solo Parent	4

Participants with no fertility issue who did not get pregnant

Group	Value	95% CI
All Participants	134
Heterosexual Females With a Male Partner	89
Females in LGBTQ Relationships	42
Solo Parent	3

Participants with a fertility issues who got pregnant

Group	Value	95% CI
All Participants	31
Heterosexual Females With a Male Partner	27
Females in LGBTQ Relationships	3
Solo Parent	1

Participants with a fertility issues who did not get pregnant

Group	Value	95% CI
All Participants	116
Heterosexual Females With a Male Partner	112
Females in LGBTQ Relationships	4
Solo Parent	0

Ease of Use Secondary · 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.

Easy Process Overall

Group	Value	95% CI
All Participants	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0
All Participants	2
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	2
Solo Parent	0
All Participants	7
Heterosexual Females With a Male Partner	6
Females in LGBTQ Relationships	1
Solo Parent	0
All Participants	101
Heterosexual Females With a Male Partner	85
Females in LGBTQ Relationships	14
Solo Parent	2

Intuitive Process

Group	Value	95% CI
All Participants	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0
All Participants	13
Heterosexual Females With a Male Partner	10
Females in LGBTQ Relationships	3
Solo Parent	0
All Participants	19
Heterosexual Females With a Male Partner	18
Females in LGBTQ Relationships	0
Solo Parent	1
All Participants	121
Heterosexual Females With a Male Partner	100
Females in LGBTQ Relationships	18
Solo Parent	3

Ease of Use: Usage Steps Secondary · 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.

Easy Sample Collection

Group	Value	95% CI
All Participants	3
Heterosexual Females With a Male Partner	1
Females in LGBTQ Relationships	2
Solo Parent	0
All Participants	16
Heterosexual Females With a Male Partner	15
Females in LGBTQ Relationships	1
Solo Parent	0
All Participants	32
Heterosexual Females With a Male Partner	18
Females in LGBTQ Relationships	11
Solo Parent	3
All Participants	112
Heterosexual Females With a Male Partner	90
Females in LGBTQ Relationships	21
Solo Parent	1

Draw up Semen

Group	Value	95% CI
All Participants	2
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	2
Solo Parent	0
All Participants	7
Heterosexual Females With a Male Partner	3
Females in LGBTQ Relationships	4
Solo Parent	0
All Participants	31
Heterosexual Females With a Male Partner	23
Females in LGBTQ Relationships	7
Solo Parent	1
All Participants	128
Heterosexual Females With a Male Partner	104
Females in LGBTQ Relationships	23
Solo Parent	1

Insert Syringe

Group	Value	95% CI
All Participants	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0
All Participants	2
Heterosexual Females With a Male Partner	1
Females in LGBTQ Relationships	1
Solo Parent	0
All Participants	8
Heterosexual Females With a Male Partner	7
Females in LGBTQ Relationships	0
Solo Parent	1
All Participants	108
Heterosexual Females With a Male Partner	91
Females in LGBTQ Relationships	16
Solo Parent	1

Deposit Sperm

Group	Value	95% CI
All Participants	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0
All Participants	10
Heterosexual Females With a Male Partner	7
Females in LGBTQ Relationships	3
Solo Parent	0
All Participants	24
Heterosexual Females With a Male Partner	20
Females in LGBTQ Relationships	3
Solo Parent	1
All Participants	105
Heterosexual Females With a Male Partner	87
Females in LGBTQ Relationships	17
Solo Parent	1

Use of the Kit as Intended Secondary · 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.

Read instructions

Group	Value	95% CI
All Participants	333
Heterosexual Females With a Male Partner	258
Females in LGBTQ Relationships	67
Solo Parent	8

Prepared items

Group	Value	95% CI
All Participants	333
Heterosexual Females With a Male Partner	256
Females in LGBTQ Relationships	69
Solo Parent	8

Washed my hands

Group	Value	95% CI
All Participants	324
Heterosexual Females With a Male Partner	251
Females in LGBTQ Relationships	65
Solo Parent	8

Tested syringe

Group	Value	95% CI
All Participants	305
Heterosexual Females With a Male Partner	234
Females in LGBTQ Relationships	63
Solo Parent	8

Partner washed hands

Group	Value	95% CI
All Participants	288
Heterosexual Females With a Male Partner	225
Females in LGBTQ Relationships	59
Solo Parent	4

Perceived Safety of Using the Mosie Kit Secondary · 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.

Strongly Disgree

Group	Value	95% CI
All Participants	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0

Disagree

Group	Value	95% CI
All Participants	1
Heterosexual Females With a Male Partner	1
Females in LGBTQ Relationships	0
Solo Parent	0

Neutral

Group	Value	95% CI
All Participants	2
Heterosexual Females With a Male Partner	2
Females in LGBTQ Relationships	0
Solo Parent	0

Agree

Group	Value	95% CI
All Participants	95
Heterosexual Females With a Male Partner	80
Females in LGBTQ Relationships	13
Solo Parent	2

Strongly Agree

Group	Value	95% CI
All Participants	252
Heterosexual Females With a Male Partner	189
Females in LGBTQ Relationships	57
Solo Parent	6

Pregnancy Rate Comparison Between Male Infertility Source and Female Infertility Source or Unknown Infertility Status Secondary · 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.

Pregnancies to participants with Issues of Female Origin

Group	Value	95% CI
All Pregnant Participants	25
Heterosexual Females With a Male Partner	20
Females in LGBTQ Relationships	3
Solo Parent	2

Pregnancies to participants with Issues of Male origin

Group	Value	95% CI
All Pregnant Participants	11
Heterosexual Females With a Male Partner	8
Females in LGBTQ Relationships	3
Solo Parent	0

Pregnancies to participants No infertility Issue

Group	Value	95% CI
All Pregnant Participants	59
Heterosexual Females With a Male Partner	39
Females in LGBTQ Relationships	18
Solo Parent	2

Pregnancies to participantsBoth Male and Female Infertility Issue

Group	Value	95% CI
All Pregnant Participants	4
Heterosexual Females With a Male Partner	4
Females in LGBTQ Relationships	0
Solo Parent	0

Comparison of Pregnancy Rate Based on Known Fertility Issue Secondary · 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.

PCOS

Group	Value	95% CI
All Participants	12
Heterosexual Females With a Male Partner	8
Females in LGBTQ Relationships	3
Solo Parent	1

Endometriosis Low AMH or low ovarian reserve

Group	Value	95% CI
All Participants	4
Heterosexual Females With a Male Partner	4
Females in LGBTQ Relationships	0
Solo Parent	0

Vaginismus or vulvodynia

Group	Value	95% CI
All Participants	6
Heterosexual Females With a Male Partner	6
Females in LGBTQ Relationships	0
Solo Parent	0

Tilted Uterus

Group	Value	95% CI
All Participants	4
Heterosexual Females With a Male Partner	4
Females in LGBTQ Relationships	0
Solo Parent	0

Low Sperm Count

Group	Value	95% CI
All Participants	6
Heterosexual Females With a Male Partner	5
Females in LGBTQ Relationships	1
Solo Parent	0

Sperm motility issues

Group	Value	95% CI
All Participants	4
Heterosexual Females With a Male Partner	4
Females in LGBTQ Relationships	0
Solo Parent	0

Erectile Dysfunction

Group	Value	95% CI
All Participants	5
Heterosexual Females With a Male Partner	5
Females in LGBTQ Relationships	0
Solo Parent	0

Performance issues or sexual anxiety, or inability to orgasm with partner

Group	Value	95% CI
All Participants	14
Heterosexual Females With a Male Partner	14
Females in LGBTQ Relationships	0
Solo Parent	0

Insemination Schedule's Impact on Pregnancy Secondary · 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 b

1st cycle : at least 2 inseminations per cycle

Group	Value	95% CI
All Participants	52
Heterosexual Females With a Male Partner	30
Females in LGBTQ Relationships	10
Solo Parent	2

1st cycle not meeting criteria

Group	Value	95% CI
All Participants	47
Heterosexual Females With a Male Partner	41
Females in LGBTQ Relationships	14
Solo Parent	2

1st cycle not reporting

Group	Value	95% CI
All Participants	0
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	0
Solo Parent	0

2nd cycles : at least 2 inseminations per cycle

Group	Value	95% CI
All Participants	18
Heterosexual Females With a Male Partner	13
Females in LGBTQ Relationships	4
Solo Parent	1

2nd cycle not meeting criteria

Group	Value	95% CI
All Participants	24
Heterosexual Females With a Male Partner	16
Females in LGBTQ Relationships	6
Solo Parent	2

2nd cycle not reporting

Group	Value	95% CI
All Participants	57
Heterosexual Females With a Male Partner	42
Females in LGBTQ Relationships	14
Solo Parent	1

3rd cycles : at least 2 inseminations per cycle

Group	Value	95% CI
All Participants	5
Heterosexual Females With a Male Partner	4
Females in LGBTQ Relationships	1
Solo Parent	0

3rd cycle not reporting

Group	Value	95% CI
All Participants	83
Heterosexual Females With a Male Partner	62
Females in LGBTQ Relationships	18
Solo Parent	3

Effect of COVID on Family Expansion Secondary · 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.

Yes

Group	Value	95% CI
All Participants	89
Heterosexual Females With a Male Partner	67
Females in LGBTQ Relationships	22
Solo Parent	0

Group	Value	95% CI
All Participants	261
Heterosexual Females With a Male Partner	205
Females in LGBTQ Relationships	48
Solo Parent	8

Pregnancy Outcomes During COVID Secondary · 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.

Conception: September 2019 Birth: June 2020

Group	Value	95% CI
Pregnancies	1
Heterosexual Females With a Male Partner	0
Females in LGBTQ Relationships	1
Solo Parent	0

Conception: October 2019 Birth: July 2020

Group	Value	95% CI
Pregnancies	3
Heterosexual Females With a Male Partner	2
Females in LGBTQ Relationships	1
Solo Parent	0

Conception: November 2019 Birth: August 2020

Group	Value	95% CI
Pregnancies	5
Heterosexual Females With a Male Partner	2
Females in LGBTQ Relationships	3
Solo Parent	0

Conception: December 2019 Birth: August 2020

Group	Value	95% CI
Pregnancies	4
Heterosexual Females With a Male Partner	3
Females in LGBTQ Relationships	0
Solo Parent	1

Conception: January 2020 Birth: September 2021

Group	Value	95% CI
Pregnancies	3
Heterosexual Females With a Male Partner	2
Females in LGBTQ Relationships	1
Solo Parent	0

Conception: February 2020 Birth: November 2021

Group	Value	95% CI
Pregnancies	10
Heterosexual Females With a Male Partner	5
Females in LGBTQ Relationships	5
Solo Parent	0

Conception: March 2020 Birth: December 2021

Group	Value	95% CI
Pregnancies	7
Heterosexual Females With a Male Partner	5
Females in LGBTQ Relationships	2
Solo Parent	0

Conception: April 2020 Birth: Jan 2021

Group	Value	95% CI
Pregnancies	16
Heterosexual Females With a Male Partner	12
Females in LGBTQ Relationships	2
Solo Parent	2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04646291 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mosie Baby
Last refreshed: 24 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04646291.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing