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

Ain Shams University

Status and phase: Unknown; Phase 1

Conditions: Fallopian Tube Occlusion

Treatments: Drug: Isoamyl-2-cyanoacrylate

Study type: Interventional

Funder types: Other

Identifiers

NCT02698644

ASU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

isoamyl2cyanoacrylate

Experimental group

Description:

Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Treatment:

Drug: Isoamyl-2-cyanoacrylate