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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

LOCAL Trial 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).

LOCAL Trial 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

LOCAL Trial Design

1Treatment groups
Experimental Treatment
Group I: FemaSeedExperimental Treatment1 Intervention
Investigational device and procedure

Find a Location

Who is running the clinical trial?

Femasys Inc.Lead Sponsor
5 Previous Clinical Trials
907 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct sites are currently overseeing this research project?

"This trail involves a total 18 medical centres. Some of the more prominent locations include Utah Center for Reproductive Medicine in Salt Lake City, University Hospital Cleveland Medical Centre in Cleveland and Centex Studies in Houston, among other institutions."

Answered by AI

Is there an open enrollment for this clinical experiment?

"According to clinicaltrials.gov, this medical trial is currently recruiting; it was first published on July 15th 2021 and recently updated October 24th 2022."

Answered by AI

Is eligibility for this study limited to individuals aged 75 or under?

"Adhering to the criteria for inclusion, only those aged 19-40 can be enrolled in this medical test."

Answered by AI

How many participants have been recruited for this experiment?

"This clinical trial requires 214 individuals that meet the necessary qualifications to participate. Locations include Utah Center for Reproductive Medicine in Salt Lake City and University Hospital Cleveland Medical Center in Ohio's largest city, Cleveland."

Answered by AI

Is there eligibility criteria that I must meet to partake in this experiment?

"This trial, which has a target recruitment of 214 individuals, is recruiting participants between 19 and 40 years old that suffer from infertility."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Ohio
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Red Rock Fertility Center
Fertility Specialist Medical Center
The Fertility Center of Las Vegas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
2
0

Why did patients apply to this trial?

We have tried 6 rounds of letrozole. I have had one IUI that was not successful.
PatientReceived no prior treatments
Hoping this clinical trial helps before making other choices with the right medicines.
PatientReceived no prior treatments
I have been trying different things to get pregnant but nothing seems to be working for me.
PatientReceived 2+ prior treatments
I have had infertility for 10 years due to endometriosis and I'm in the process of doing IUI.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many visits are needed? How long is the screening process? Is IVG an option for trials anywhere in the world?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
FemaSeed LOCAL Artificial Insemination Trial
2021. "FemaSeed LOCAL Artificial Insemination Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968847.
All > Infertility
~57 spots leftby Apr 2025
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