Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate

Conditions
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Fallopian Tube Occlusion

Intervention / Treatment
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* Drug: Isoamyl-2-cyanoacrylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope Exclusion Criteria: Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isoamyl2cyanoacrylate<br>Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter | Drug: Isoamyl-2-cyanoacrylate<br>* Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter<br>* Other names: AMCRYLATE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fallopian tube obstruction | assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements. | from one day to four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree and extend of inflammation in the fallopian tubes | assessments of this outcome will be done by histopathological examination for severity of inflammatory cellular changes and extend of these inflammatory changes through different layers of the wall of the fallopian tubes | from one day to four weeks |