FemaSeed Localized Directional Insemination for Infertility

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
InfertilityFemaSeed Localized Directional Insemination - Device
Eligibility
19 - 40
Female
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 7 weeks

3 weeks
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.
7 weeks
Primary Effectiveness: Confirmed clinical pregnancy with fetal heartbeat rate
Primary Safety: Occurrence of ectopic pregnancy per cycle
At time of procedure
Primary Safety: Occurrence of uterine perforation per cycle

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

FemaSeed
1 of 1

Experimental Treatment

214 Total Participants · 1 Treatment Group

Primary Treatment: FemaSeed Localized Directional Insemination · No Placebo Group · N/A

FemaSeed
Device
Experimental Group · 1 Intervention: FemaSeed Localized Directional Insemination · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 weeks

Who is running the clinical trial?

Femasys Inc.Lead Sponsor
4 Previous Clinical Trials
334 Total Patients Enrolled

Eligibility Criteria

Age 19 - 40 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least one patent fallopian tube with no evidence of hydrosalpinx.

Who else is applying?

What state do they live in?
Texas23.3%
Ohio13.3%
Florida10.0%
Other53.3%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Cincinnati Physicians11.1%
Red Rock Fertility Center11.1%
Center of Reproductive Medicine11.1%
Other66.7%
What portion of applicants met pre-screening criteria?
Met criteria89.7%
Did not meet criteria10.3%
Why did patients apply to this trial?
  • "I have been trying different things to get pregnant but nothing seems to be working for me"
  • "Ive had my tubes tied and want to see if i can get pregnant thru ivf again, me and my husband want to have a baby"
  • "I'm 44 and with my 3rd fertility specialist. My cervical fluid seems to kill sperm. 8 failed IUI and 2 failed ivf."
  • "I have been trying to get pregnant for the last 7-8 years with no success, I cannot afford full treatment and would love to do a clinical trial in attempt to get pregnant."
How many prior treatments have patients received?
050.0%
225.0%
3+25.0%
What questions have other patients asked about this trial?
  • "How long is the screening process?"