What is the mechanism of action of this treatment?

The FemaSeed Localized Directional Insemination trial focuses on the targeted delivery of sperm to the optimal location within the reproductive tract, enhancing fertilization rates by ensuring that a higher concentration of motile sperm reaches the egg. This method is particularly beneficial for patients with unexplained infertility or mild male factor infertility, as it increases the chances of sperm-egg interaction. Other common treatments include intrauterine insemination (IUI), where sperm is directly placed into the uterus, and in vitro fertilization (IVF), where eggs are fertilized outside the body and then implanted into the uterus. These treatments aim to overcome various barriers to fertilization, such as low sperm count or poor motility, and are crucial for patients struggling to conceive naturally.

What side effects are associated with this type of intervention?

Common treatments for infertility similar to FemaSeed Localized Directional Insemination include intrauterine insemination (IUI) and in vitro fertilization (IVF). The side effects of IUI are generally mild and may include cramping, spotting, and a small risk of infection. IVF, which is more invasive, can have side effects such as ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, and complications from egg retrieval like bleeding or infection. Both treatments may also cause emotional stress and financial strain.

What prior FDA approvals exist?

The FDA has approved several treatments for infertility that focus on enhancing fertilization rates through optimized sperm delivery. One such treatment is intrauterine insemination (IUI), where sperm is directly placed into a woman's uterus to facilitate fertilization. Additionally, intracytoplasmic sperm injection (ICSI) is another FDA-approved technique where a single sperm is injected directly into an egg to aid fertilization, often used in conjunction with in vitro fertilization (IVF). These treatments aim to improve the chances of pregnancy by ensuring that sperm reaches the optimal location within the reproductive tract or directly interacts with the egg.

What other types of research exist?

Promising novel alternatives to FemaSeed Localized Directional Insemination for infertility patients include: 1) Deep intrauterine insemination, which places sperm directly into the uterine horns to improve sperm transport and fertilization rates. 2) Transcervical cannulation of the fallopian tubes, which can clear blockages and place gametes or embryos directly into the tubes. 3) Microdissection testicular sperm extraction, particularly for men with non-obstructive azoospermia, to retrieve viable sperm for use in assisted reproductive techniques.

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Artificial Insemination Device

Directional Artificial Insemination for Infertility (LOCAL Trial)

N/A

Waitlist Available

Research Sponsored by Femasys Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of procedure

Awards & highlights

Summary

This trial is testing a new method called FemaSeed Localized Directional Insemination for artificial insemination. It aims to help individuals or couples who are trying to conceive by placing sperm in a specific location within the reproductive system. This targeted approach is designed to improve the chances of pregnancy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort during the procedure and risks associated with methotrexate treatment if an ectopic pregnancy occurs (which might involve nausea, mouth sores, low blood counts).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.

Primary Safety: Occurrence of ectopic pregnancy per cycle

Primary Safety: Occurrence of uterine perforation per cycle

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device: FemaSeed Localized Directional InseminationExperimental Treatment1 Intervention

FemaSeed (Intratubal Insemination - K231730)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FemaSeed Localized Directional Insemination

2021

N/A

~800

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The FemaSeed Localized Directional Insemination trial focuses on the targeted delivery of sperm to the optimal location within the reproductive tract, enhancing fertilization rates by ensuring that a higher concentration of motile sperm reaches the egg. This method is particularly beneficial for patients with unexplained infertility or mild male factor infertility, as it increases the chances of sperm-egg interaction. Other common treatments include intrauterine insemination (IUI), where sperm is directly placed into the uterus, and in vitro fertilization (IVF), where eggs are fertilized outside the body and then implanted into the uterus. These treatments aim to overcome various barriers to fertilization, such as low sperm count or poor motility, and are crucial for patients struggling to conceive naturally.

Effect of sperm dose on pregnancy rate from intrauterine insemination: a retrospective analysis.Correlation between semen parameters of electroejaculates and achieving pregnancy by intrauterine insemination.Proteomic analysis reveals the negative modulator of sperm function glycodelin as over-represented in semen exosomes isolated from asthenozoospermic patients.

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Who is running the clinical trial?

Femasys Inc.Lead Sponsor

5 Previous Clinical Trials

907 Total Patients Enrolled

~190 spots leftby Sep 2025

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