Trials / Completed
CompletedNCT04968847
FemaSeed LOCAL Artificial Insemination Trial
LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Femasys Inc. · Industry
- Sex
- Female
- Age
- 19 Years – 40 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FemaSeed Localized Directional Insemination | Subjects undergoing FemaSeed Artificial Insemination |
Timeline
- Start date
- 2021-07-15
- Primary completion
- 2023-12-31
- Completion
- 2024-04-30
- First posted
- 2021-07-20
- Last updated
- 2024-11-08
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04968847. Inclusion in this directory is not an endorsement.