FemaSeed LOCAL Artificial Insemination Trial

Last updated: November 7, 2024
Sponsor: Femasys Inc.
Overall Status: Completed

Phase

N/A

Condition

Infertility

Treatment

FemaSeed Localized Directional Insemination

Clinical Study ID

NCT04968847
CP-200-001
  • Ages 19-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 314
Treatment Group(s): 1
Primary Treatment: FemaSeed Localized Directional Insemination
Phase:
Study Start date:
July 15, 2021
Estimated Completion Date:
April 30, 2024

Study 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).

Connect with a study center

  • Elite IVF, PLLC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Fertility Specialist Medical Center

    San Diego, California 92123
    United States

    Site Not Available

  • Reproductive Associates of Delaware (RAD Fertility)

    Newark, Delaware 19713
    United States

    Site Not Available

  • Women's Medical Research Group, LLC

    Clearwater, Florida 33759
    United States

    Site Not Available

  • Rosemark Women Care Specialists

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Saginaw Valley Medical Research Group

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Red Rock Fertility Center

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • The Fertility Center of Las Vegas

    Las Vegas, Nevada 89117
    United States

    Site Not Available

  • Reach Fertility

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Reproductive Endocrinology Associates of Charlotte PC

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Carolina Conceptions

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Institute for Reproductive Health

    Cincinnati, Ohio 45209
    United States

    Site Not Available

  • University of Cincinnati Physicians

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Main Line Fertility

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • University of Pennsylvania (Pennsylvania Fertility Care)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Centex Studies

    Houston, Texas 77058
    United States

    Site Not Available

  • LinQ Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Center of Reproductive Medicine

    Webster, Texas 77598
    United States

    Site Not Available

  • Utah Center for Reproductive Medicine

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • University of Wisconsin, Generations Fertility Care

    Middleton, Wisconsin 53562
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.