Directional Artificial Insemination for Infertility

(LOCAL Trial)

No longer recruiting at 21 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Femasys Inc.

Disqualifiers: More than 3 IUI cycles, recent pelvic infection, ectopic pregnancy history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

Known allergy/sensitivity to methotrexate

I have not had a pelvic infection in the last 3 months.

I have undergone more than three IUI cycles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FemaSeed Localized Directional Insemination procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for confirmed pregnancy and safety outcomes after the procedure

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FemaSeed Localized Directional Insemination

Trial Overview

The FemaSeed Localized Directional Insemination technique is being tested for its safety and effectiveness in artificial insemination compared to standard procedures. The study aims to help couples with male factor infertility conceive.

How Is the Trial Designed?

Group I: Device: FemaSeed Localized Directional Insemination Experimental Treatment 1 Intervention

FemaSeed (Intratubal Insemination - K231730)

Who Is Running the Clinical Trial?

Femasys Inc.

Lead Sponsor

Trials

6

Recruited

1,200+

Published Research Related to This Trial

Assisted reproduction techniques (ART) have significantly improved the chances of conception for infertile couples, but the use of pharmacological agents in ART can lead to various adverse effects, including ovarian hyperstimulation syndrome and potential congenital malformations.

While gonadotropins are effective in stimulating ovarian function, they may be associated with risks such as luteal phase deficiency and concerns about long-term cancer risks, although these have not been conclusively proven.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of drugs used in assisted reproduction techniques. Al-Shawaf, T., Zosmer, A., Dirnfeld, M., et al.[2018]

Citations

1.

ir.femasys.com

ir.femasys.com/news/news-details/2024/Femasys-Announces-Positive-Topline-Data-from-Pivotal-Trial-for-its-FDA-Cleared-FemaSeed-for-the-Treatment-of-Infertility/default.aspx

News Details

In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed - - FemaSeed pregnancy rate by cycle was more ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04968847

FemaSeed LOCAL Artificial Insemination Trial

Brief Summary: The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial ...

3.

femaseed.com

femaseed.com/downloads/femaseed-clinical-data-publication-20241206.pdf

Journal of Gynecology & Reproductive Medicine

The primary endpoint was confirmed pregnancy rate (PR) at 3 weeks post-insemination in couples with male-factor/unexplained infertility and TMSC of 1-20 million ...

4.

femaseed.com

femaseed.com/hcp/index

Home | FemaSeed Intratubal Insemination

FemaSeed is an intratubal insemination approach without catheterization. FemaSeed delivers washed sperm precisely into the selected fallopian tube.

5.

withpower.com

withpower.com/trial/phase-infertility-6-2021-53fb4

Directional Artificial Insemination for Infertility (LOCAL Trial)

This trial is testing a new method called FemaSeed Localized Directional Insemination for artificial insemination. It aims to help individuals or couples ...

6.

ir.femasys.com

ir.femasys.com/news/news-details/2024/Femasys-Announces-Peer-Reviewed-Publication-of-Positive-Data-from-Prospective-Multicenter-Pivotal-Trial-of-FemaSeed-Infertility-Treatment/default.aspx

News Details

“Our impressive pivotal data for FemaSeed, showed significantly improved pregnancy rates, over double that of intrauterine insemination (IUI) ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K231730.pdf

September 22, 2023 Femasys, Inc. Christine Thomas SVP ...

The results of the testing described above demonstrate that the FemaSeed Intratubal. Insemination transfer catheters are as safe and effective ...