FemaSeed LOCAL Artificial Insemination Trial (LOCAL)

November 7, 2024 updated by: Femasys Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Elite IVF, PLLC
    • Delaware
      • Newark, Delaware, United States, 19713
        • Reproductive Associates of Delaware (RAD Fertility)
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialists
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • The Fertility Center of Las Vegas
      • Las Vegas, Nevada, United States, 89148
        • Red Rock Fertility Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Reach Fertility
      • Raleigh, North Carolina, United States, 27607
        • Carolina Conceptions
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Institute for Reproductive Health
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Physicians
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Fertility
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania (Pennsylvania Fertility Care)
    • Texas
      • Sugar Land, Texas, United States, 77479
        • LinQ Research
      • Webster, Texas, United States, 77598
        • Center of Reproductive Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Utah Center for Reproductive Medicine
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • University of Wisconsin, Generations Fertility Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device: FemaSeed Localized Directional Insemination
FemaSeed (Intratubal Insemination - K231730)
Device: FemaSeed Localized Directional Insemination
Subjects undergoing FemaSeed Artificial Insemination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.
Time Frame: 3 weeks
Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.
3 weeks
Primary Safety: Occurrence of ectopic pregnancy per cycle
Time Frame: 7 weeks
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)
7 weeks
Primary Safety: Occurrence of uterine perforation per cycle
Time Frame: At time of procedure
Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.
At time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Femasys Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-200-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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