Fallopian Tube Occlusion Clinical Trial
Official title:
Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate
Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.
The study will be conducted according to the guidelines on human experimentation of the 1975
Declaration of Helsinki. For all patients after taking signed informed consent ,
transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian
tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of
Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.
All the surgical procedures will be performed without anesthesia, only premedication with an
NSAID (e.g. NaproxenR) is given orally one hour before the procedure.
Each patient will be under close observation for the first 24 hours postprocedure for any
signs of inflammation as abdominal pain, tenderness or fever and for the vital data.
Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a
week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will
be sent to histopathologist to assess the degree of tubal occlusion and the extent and the
severity of inflammation in the tubal wall.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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N/A | |
| Recruiting |
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