Hydrosalpinx, Infertility, Female
Conditions
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.
Interventions
DRUGIsoamyl 2-Cyanoacrylate
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fallopian tubal occlusion in patients with hydrosalpinx. | from one to three months |
Countries
Egypt
Contacts
Primary ContactMohamed I Amer, MD
Outcome results
None listed