FemaSeed LOCAL Artificial Insemination Trial

Femasys

Status: Completed

Conditions: Infertility; Male Factor

Treatments: Device: FemaSeed Localized Directional Insemination

Study type: Interventional

Funder types: Industry

Identifiers

NCT04968847

CP-200-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 314 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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314 participants in 1 patient group

Device: FemaSeed Localized Directional Insemination

Experimental group

Description:

FemaSeed (Intratubal Insemination - K231730)

Treatment:

Device: FemaSeed Localized Directional Insemination