Directional Artificial Insemination for Infertility
(LOCAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment for infertility called FemaSeed Localized Directional Insemination. The goal is to evaluate the safety and effectiveness of this method in helping women become pregnant. Women aged 19-40 with no known issues with their fallopian tubes, uterus, or ovaries may be suitable candidates for this trial. Those who have undergone intrauterine insemination (IUI) three or more times or have had a recent pelvic infection may not qualify. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in infertility treatment.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the FemaSeed Localized Directional Insemination is safe for artificial insemination?
Research shows that FemaSeed Localized Directional Insemination is generally safe. The FDA has cleared the treatment, indicating it has been reviewed and deemed safe for its intended use. Although specific safety data for this treatment is unavailable, FDA clearance provides some reassurance.
Studies have shown that FemaSeed treatment increases pregnancy rates, suggesting participants tolerated it well. The catheters used in the treatment proved to be as safe and effective as expected. So far, no significant side effects have been reported, which is a positive sign for human safety.12345Why are researchers excited about this trial?
Researchers are excited about FemaSeed Localized Directional Insemination because it offers a new approach to treating infertility by directing sperm precisely to the fallopian tubes, where fertilization naturally occurs. Unlike standard artificial insemination methods, which deposit sperm in the uterus and rely on them to find their way to the tubes, FemaSeed's intratubal insemination potentially increases the chances of sperm and egg meeting. This targeted delivery method could enhance the efficiency and effectiveness of the insemination process, offering new hope for couples struggling with infertility.
What evidence suggests that the FemaSeed Localized Directional Insemination is effective for infertility?
Research has shown that FemaSeed Localized Directional Insemination, the treatment under study in this trial, offers a promising option for infertility. In studies focusing on male-factor infertility, approximately 24% of women became pregnant after using FemaSeed. This method places specially prepared sperm directly into the fallopian tube to enhance fertilization chances. Designed for precision, the treatment avoids inserting a tube into the uterus, making it less invasive. These findings suggest that FemaSeed could effectively assist those struggling with traditional insemination methods.13467
Are You a Good Fit for This Trial?
This trial is for couples facing male infertility, where the woman is aged 19-40 without tubal, uterine or ovarian issues and has at least one open fallopian tube. Men must have a certain sperm count after preparation. Participants can't have had more than three IUI cycles, past ectopic pregnancies or tubal surgeries, recent pelvic infections, or allergies to methotrexate.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the FemaSeed Localized Directional Insemination procedure
Follow-up
Participants are monitored for confirmed pregnancy and safety outcomes after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- FemaSeed Localized Directional Insemination
Find a Clinic Near You
Who Is Running the Clinical Trial?
Femasys Inc.
Lead Sponsor