A Thin Catheter For Hystrosalpingography

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Device: device for hysterosalpingography

• Registration Number: NCT01032642
• Lead Sponsor: Kasr El Aini Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2008-09
• Study Start: 2008-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Last Update Submitted: 2009-12-15
• Last Update Posted: 2009-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• women with pelvic inflammatory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thin catheter group	device for hysterosalpingography	group of women where thin catheter will be used for hysterosalpingography

Primary Outcome Measures

Name	Time	Method
pain score during introduction of catheter and during the injection of dye	3-6 month
the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes	3-6 month

Secondary Outcome Measures

Name	Time	Method
adverse events	within the study period

Trial Locations

Locations (1)

kasr Al-Aini hospital; 🇪🇬 Cairo, Egypt