FemaSeed LOCAL Artificial Insemination Trial
NCT04968847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314
Last updated 2024-11-08
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.
Conditions
- Infertility
- Male Factor
Interventions
- DEVICE
-
FemaSeed Localized Directional Insemination
Subjects undergoing FemaSeed Artificial Insemination
Sponsors & Collaborators
-
Femasys Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-15
- Primary Completion
- 2023-12-31
- Completion
- 2024-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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