FemaSeed LOCAL Artificial Insemination Trial

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

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.

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).

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