Clinical trial NCT04968847: FemaSeed LOCAL Artificial Insemination Trial
Official title: LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Male Factor
Keywords: Infertility
IUI
Intrauterine Insemination
Unexplained
Male
Sperm
Lead sponsor: Femasys Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 314
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, single-arm
Primary purpose: TREATMENT

Brief summary: Brief Summary: The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination, now known as the FemaSeed Intratubal Insemination since FDA Cleared under K231730 in September 2023.

Detailed description: 314 subjects enrolled (signed inform consent) inclusive of 188 subjects in protocol versions 1-4 and 126 subjects in protocol version 5 (including re-consented subjects).

Eligibility criteria: Inclusion Criteria:

1. Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)

Exclusion Criteria:

1. Greater than three prior intrauterine insemination (IUI) cycles
2. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes)
3. Prior history of ectopic pregnancy or tubal surgery

Primary outcomes:
measure: Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.
timeFrame: 3 weeks
measure: Primary Safety: Occurrence of ectopic pregnancy per cycle
timeFrame: 7 weeks
measure: Primary Safety: Occurrence of uterine perforation per cycle
timeFrame: At time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Elite IVF, PLLC
state: Alabama
city: Newark
country: United States
facility: Reproductive Associates of Delaware (RAD Fertility)
state: Delaware
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group
state: Michigan
city: Las Vegas
country: United States
facility: The Fertility Center of Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Red Rock Fertility Center
state: Nevada
city: Charlotte
country: United States
facility: Reach Fertility
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Conceptions
state: North Carolina
city: Cincinnati
country: United States
facility: Institute for Reproductive Health
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania (Pennsylvania Fertility Care)
state: Pennsylvania
city: Sugar Land
country: United States
facility: LinQ Research
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Utah Center for Reproductive Medicine
state: Utah
city: Middleton
country: United States
facility: University of Wisconsin, Generations Fertility Care
state: Wisconsin
Study officials:
References: