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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 whether a new method for artificial insemination is safe and effective.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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: FemaSeedExperimental Treatment1 Intervention
Investigational device and procedure

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.

Find a Location

Who is running the clinical trial?

Femasys Inc.Lead Sponsor
5 Previous Clinical Trials
907 Total Patients Enrolled
~53 spots leftby Jul 2025