FemaSeed LOCAL Artificial Insemination Trial

LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04968847

Acronym

LOCAL

Enrollment

314

Registered

2021-07-20

Start date

2021-07-15

Completion date

2024-04-30

Last updated

2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male Factor

Keywords

Infertility, IUI, Intrauterine Insemination, Unexplained, Male, Sperm

Brief summary

Brief Summary: The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination, now known as the FemaSeed Intratubal Insemination since FDA Cleared under K231730 in September 2023.

Detailed description

314 subjects enrolled (signed inform consent) inclusive of 188 subjects in protocol versions 1-4 and 126 subjects in protocol version 5 (including re-consented subjects).

Interventions

DEVICEFemaSeed Localized Directional Insemination

Subjects undergoing FemaSeed Artificial Insemination

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective, multi-center, single-arm

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)

Exclusion criteria

1. Greater than three prior intrauterine insemination (IUI) cycles 2. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes) 3. Prior history of ectopic pregnancy or tubal surgery

Design outcomes

Primary

Measure	Time frame	Description
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.	3 weeks	Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.
Primary Safety: Occurrence of ectopic pregnancy per cycle	7 weeks	Occurrence of ectopic pregnancy per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in a definitively confirmed ectopic pregnancy (based on current accepted clinical standards)
Primary Safety: Occurrence of uterine perforation per cycle	At time of procedure	Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026