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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: FemaSeed Localized Directional Insemination | Experimental | FemaSeed (Intratubal Insemination - K231730) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemaSeed Localized Directional Insemination | Device | Subjects undergoing FemaSeed Artificial Insemination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure. | Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy. | 3 weeks |
| Primary Safety: Occurrence of ectopic pregnancy per cycle | 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) | 7 weeks |
| Primary Safety: Occurrence of uterine perforation per cycle | Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation. | At time of procedure |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elite IVF, PLLC | Mobile | Alabama | 36608 | United States | ||
| Reproductive Associates of Delaware (RAD Fertility) |
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Prospective, multi-center, single-arm
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| Newark |
| Delaware |
| 19713 |
| United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Saginaw Valley Medical Research Group | Saginaw | Michigan | 48604 | United States |
| The Fertility Center of Las Vegas | Las Vegas | Nevada | 89117 | United States |
| Red Rock Fertility Center | Las Vegas | Nevada | 89148 | United States |
| Reach Fertility | Charlotte | North Carolina | 28207 | United States |
| Carolina Conceptions | Raleigh | North Carolina | 27607 | United States |
| Institute for Reproductive Health | Cincinnati | Ohio | 45209 | United States |
| University of Cincinnati Physicians | Cincinnati | Ohio | 45229 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Main Line Fertility | Bryn Mawr | Pennsylvania | 19010 | United States |
| University of Pennsylvania (Pennsylvania Fertility Care) | Philadelphia | Pennsylvania | 19104 | United States |
| LinQ Research | Sugar Land | Texas | 77479 | United States |
| Center of Reproductive Medicine | Webster | Texas | 77598 | United States |
| Utah Center for Reproductive Medicine | Salt Lake City | Utah | 84108 | United States |
| University of Wisconsin, Generations Fertility Care | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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