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

Primary Purpose

Hydrosalpinx, Infertility, Female

Status

Unknown status

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Isoamyl 2-Cyanoacrylate

About this trial

This is an interventional supportive care trial for Hydrosalpinx

Eligibility Criteria

22 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Acute Pelvic inflammatory disease.
Intra uterine pathology

Sites / Locations

AIn Shams University Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iso-Amyl 2-Cyano Acrylate

Arm Description

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

Outcomes

Primary Outcome Measures

Fallopian tubal occlusion in patients with hydrosalpinx.

Secondary Outcome Measures

Full Information

NCT ID

NCT02977234

First Posted

November 23, 2016

Last Updated

December 25, 2017

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02977234

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydrosalpinx, Infertility, Female

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iso-Amyl 2-Cyano Acrylate

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Isoamyl 2-Cyanoacrylate

Primary Outcome Measure Information:

Title

Fallopian tubal occlusion in patients with hydrosalpinx.

Time Frame

from one to three months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF. Exclusion Criteria: Acute Pelvic inflammatory disease. Intra uterine pathology

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed I Amer, MD

Phone

oo2o1oo1519370

mohamed_amer810@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed I Amer, MD

Organizational Affiliation

Ain Shams University maternity hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

AIn Shams University Maternity Hospital

City

Cairo

ZIP/Postal Code

11357

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Amer, MD

Phone

00201001519370

mohamed_amer810@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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