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

Phase 1

• Conditions: Fallopian Tube Occlusion
• Interventions: Drug: Isoamyl-2-cyanoacrylate

• Registration Number: NCT02698644
• Lead Sponsor: Ain Shams University

Brief Summary

Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.

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 both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.

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.

Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope

Exclusion Criteria

• Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
isoamyl2cyanoacrylate	Isoamyl-2-cyanoacrylate	Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Primary Outcome Measures

Name	Time	Method
fallopian tube obstruction	from one day to four weeks	assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements.

Secondary Outcome Measures

Name	Time	Method
degree and extend of inflammation in the fallopian tubes	from one day to four weeks	assessments of this outcome will be done by histopathological examination for severity of inflammatory cellular changes and extend of these inflammatory changes through different layers of the wall of the fallopian tubes

Trial Locations

Locations (1)

AIn Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt