Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adiana Device | Experimental | All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adiana placement | Device | All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx | Analysis of results will be performed on the intent-to-treat population defined as all subjects in whom device placement was attempted and on the per protocol population defined as all subjects who had successful placement of the Adiana occlusion device and were followed for a minimum of one year post HSG confirmation test. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Observe implantation and clinical pregnancy rates post IVF | Factors affecting the placement rate, tubal occlusion rate, and clinical pregnancy rate will be reviewed. This study employs an unblended, non randomized, single group design, in which subjects serve as their own controls. Because this feasibility study will enroll a maximum of ten (10) subjects, it is not designed with success/failure benchmarks, nor is it statistically powered to make any claims regarding effectiveness of hysteroscopic proximal tubal occlusion in women with hydrosalpinx who are planning to undergo IVF. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Science Center | Recruiting | San Ramon | California | 94583 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1Year |