Hysteroscopic Tubal Occlusion Using Amacrylate With or Without Lipidol in Patients With Hydrosalpinx Prior to IVF

Study Overview
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Brief Summary
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Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF

Detailed Description
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hysteroscopic injection of iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx requiring IVF. after one months and two months of the primary injection hysterosalpingography will be done to test for tubal occlusion.

Official Title
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Hysteroscopic Tubal Occlusion Using Iso-amyl- 2-cyanoacrylate With or Without Ethiodized Oil (Lipidol) in Patients With Hydrosalpinx Prior to IVF

Conditions
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Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF

Intervention / Treatment
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* Drug: iso-amyl- 2-cyanoacrylate.
* Drug: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF Exclusion Criteria: • Any patient with acute pelvic inflammatory disease, endometritis, lower genital tract infection. The presence of intrauterine synechiae that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy. The presence of uterine anomalies that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy. Undiagnosed genital bleeding.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil<br>Group 2 including 20 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil. | Drug: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil<br>* iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil (Lipidol)<br>|
| Active Comparator: Hysteroscopic tubal occlusion using only iso-amyl- 2-cyanoacrylate<br>Group 1 including 25 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate . | Drug: iso-amyl- 2-cyanoacrylate.<br>* Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate in patients with hydrosalpinx prior to IVF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fallopian tube occlusion | hysteosaplingographic diagnosis of tubal occlusion | one to three months |