FemaSeed LOCAL Artificial Insemination Trial

Femasys Inc.314 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

314

Conditions

Infertility Male Factor

Interventions

FemaSeed Localized Directional InseminationDEVICE

Subjects undergoing FemaSeed Artificial Insemination

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (18)

Elite IVF, PLLC

Mobile, Alabama, United States

Reproductive Associates of Delaware (RAD Fertility)

Newark, Delaware, United States

Outcomes

Primary Outcomes

Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.

Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.

Time frame: 3 weeks

Primary Safety: Occurrence of ectopic pregnancy per cycle

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)

Time frame: 7 weeks

Primary Safety: Occurrence of uterine perforation per cycle

Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.

Time frame: At time of procedure

Data from ClinicalTrials.gov

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