Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx

December 25, 2017 updated by: Mohamed I Amer, Ain Shams University

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

The purpose of this study is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 fallopian tubes with hydrosalpinx, will be done using a 4 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected.

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.

Hysterosalpingography will be done for all patients 0ne and 3 months postinjection to confirm tubal occlusion prior to IVF.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11357
        • Recruiting
        • Ain Shams University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF.

Exclusion Criteria:

  1. Acute Pelvic inflammatory disease.
  2. Intra uterine pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Iso-Amyl 2-Cyano Acrylate
Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx
Drug: Isoamyl 2-Cyanoacrylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fallopian tubal occlusion in patients with hydrosalpinx.
Time Frame: from one to three months
from one to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

November 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 25, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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