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

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02977234

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hydrosalpinx Infertility, Female	Drug: Isoamyl 2-Cyanoacrylate	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fallopian tubal occlusion in patients with hydrosalpinx. [from one to three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIn Shams University Maternity Hospital	Cairo		Egypt	11357

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Mohamed I Amer, MD, Ain Shams University maternity hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed I Amer, Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT02977234

Other Study ID Numbers:

ASU123

First Posted:

Nov 30, 2016

Last Update Posted:

Dec 27, 2017

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Dec 27, 2017