A Thin Catheter For Hystrosalpingography

Infertility Clinical Trial

— HSG  

Official title:

A Simple Technique to Reduce the Pain in Hysterosalpingography Using A Thin Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032642
• Other study ID #: Inany-1
• Status: Completed
• Phase: N/A
• First received: December 11, 2009
• Last updated: December 15, 2009
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2008
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators will use a thin catheter for HSG and apply pressure on the cervix with the vaginal speculum to prevent leakage of the dye during injection to study the uterine cavity and fallopian tubes and reduce the pain as compared to a standard metal cannula.

Description:

Hysterosalpingography (HSG) remains one of the most reliable methods to study tubal patency and the uterine cavity (1-3). The relative indications and importance of HSG and laparoscopy in the diagnosis of tubal factor infertility have been extensively discussed. Recently a multicenter randomized controlled trial (4) has demonstrated that the routine use of HSG at an early stage of infertility work up, prior to laparoscopy and dye, does not influence the cumulative pregnancy rate compared with the routine use of laparoscopy and dye alone. However, HSG is an efficient method which is less invasive and less costly than laparoscopy (5), and than transvaginal hydrolaparoscopy (6). The main disadvantages of HSG are being unable to confirm adhesions, endometriosis and being a painful procedure (7,8). Different cannulas and catheters have been tried to reduce pain such as the Rubin cannula (9), Jorcho cannula (10), and Whitehead cannula or Foley catheter (11). Minimal difference in the degree of pain was found when the balloon catheter was compared with the cervical cup (12). General and local medications have been tried to alleviate pain during the procedure. (3,13).

HSG is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. It is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. The aim of this pilot study was to develop a simple and painless technique for HSG using a thinner than normal catheter, and without grasping the cervix with a tenaculum. Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum. This technique for performing HSG is a novel one and has not been described previously in the medical literature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• infertile women during their fertility workup and requesting to do hysterosalpingography

Exclusion Criteria:

• women with pelvic inflammatory disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• device for hysterosalpingography
a thin catheter originally designed for IUI (sperm processor cat. No. SP/PL/01, Aurangabad, India) connected to a 10 mL syringe filled with urographin 76% (Scherring, Germany) will be introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum will be loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye will be injected slowly and the procedure will be watched on the screen and x-ray films will be taken.

Locations

Country	Name	City	State
Egypt	kasr Al-Aini hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Kasr El Aini Hospital	The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score during introduction of catheter and during the injection of dye		3-6 month	Yes
Primary	the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes		3-6 month	No
Secondary	adverse events		within the study period	Yes