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

Phase 1

• Conditions: Infertility, Female; Hydrosalpinx
• Interventions: Drug: Isoamyl 2-Cyanoacrylate

• Registration Number: NCT02977234
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-25
• Last Update Posted: 2017-12-27
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iso-Amyl 2-Cyano Acrylate	Isoamyl 2-Cyanoacrylate	Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx

Primary Outcome Measures

Name	Time	Method
Fallopian tubal occlusion in patients with hydrosalpinx.	from one to three months

Trial Locations

Locations (1)

AIn Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt