Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02698644
Other study ID # ASU
Secondary ID
Status Recruiting
Phase Phase 1
First received February 19, 2016
Last updated February 29, 2016
Start date January 2016
Est. completion date July 2016

Study information

Verified date February 2016
Source Ain Shams University
Contact Mohamed I Amer, MD
Phone 00201001519370
Email mohamed_amer810@yahoo.com
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 55 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

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 tube obstruction assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements. from one day to four weeks Yes
Secondary degree and extend of inflammation in the fallopian tubes 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 from one day to four weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT04071392 - Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Completed NCT04077242 - Hysteroscopic Evaluation of Fallopian Tubal Patency N/A
Recruiting NCT03116867 - Sonosalpingography After Hysteroscopic Tubal Occlusion N/A