FemaSeed LOCAL Artificial Insemination Trial

Not Applicable

Completed

• Conditions: Male Factor; Infertility

• Registration Number: NCT04968847
• Lead Sponsor: Femasys Inc.

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).

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Study Start: 2021-07-15
• Study First Posted: 2021-07-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 314

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety: Occurrence of uterine perforation per cycle	At time of procedure	Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.	3 weeks	Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.
Primary Safety: Occurrence of ectopic pregnancy per cycle	7 weeks	Occurrence of ectopic pregnancy per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in a definitively confirmed ectopic pregnancy (based on current accepted clinical standards)

Trial Locations

Locations (18)

Elite IVF, PLLC; 🇺🇸 Mobile, Alabama, United States

Reproductive Associates of Delaware (RAD Fertility); 🇺🇸 Newark, Delaware, United States

Women's Medical Research Group, LLC; 🇺🇸 Clearwater, Florida, United States

Rosemark Women Care Specialists; 🇺🇸 Idaho Falls, Idaho, United States

Saginaw Valley Medical Research Group; 🇺🇸 Saginaw, Michigan, United States

The Fertility Center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Red Rock Fertility Center; 🇺🇸 Las Vegas, Nevada, United States

Reach Fertility; 🇺🇸 Charlotte, North Carolina, United States

Carolina Conceptions; 🇺🇸 Raleigh, North Carolina, United States

Institute for Reproductive Health; 🇺🇸 Cincinnati, Ohio, United States

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