FemaSeed LOCAL Artificial Insemination Trial

Completed · Not applicable

Conditions studied: Infertility, Male Factor

In brief

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.

Key facts

Study ID

NCT04968847

Run by

Femasys Inc.

People needed

314

Starts

2021-07-15

Expected to finish

2024-04-30

Last updated by the study team

2024-11-08

Who can join

Age: 19 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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
• University of Cincinnati Physicians — Cincinnati, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Main Line Fertility — Bryn Mawr, Pennsylvania, United States
• University of Pennsylvania (Pennsylvania Fertility Care) — Philadelphia, Pennsylvania, United States
• LinQ Research — Sugar Land, Texas, United States
• Center of Reproductive Medicine — Webster, Texas, United States
• Utah Center for Reproductive Medicine — Salt Lake City, Utah, United States
• University of Wisconsin, Generations Fertility Care — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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