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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977234
• Other study ID #: ASU123
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 23, 2016
• Last updated: December 25, 2017
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2017
• Source: Ain Shams University
• Contact: Mohamed I Amer, MD
• Phone: oo2o1oo1519370
• Email: mohamed_amer810[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrosalpinx
• Infertility
• Infertility, Female

Intervention

Drug:
• Isoamyl 2-Cyanoacrylate

Locations

Country	Name	City	State
Egypt	AIn Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fallopian tubal occlusion in patients with hydrosalpinx.		from one to three months