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A Thin Catheter For Hystrosalpingography (HSG)

This study has been completed.
Sponsor:
Collaborator:
The Egyptian IVF-ET Center
Information provided by:
Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT01032642
First received: December 11, 2009
Last updated: December 15, 2009
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Device: device for hysterosalpingography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Simple Technique to Reduce the Pain in Hysterosalpingography Using A Thin Catheter

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Kasr El Aini Hospital:

Primary Outcome Measures:
  • pain score during introduction of catheter and during the injection of dye [ Time Frame: 3-6 month ] [ Designated as safety issue: Yes ]
  • the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes [ Time Frame: 3-6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: within the study period ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: thin catheter group
group of women where thin catheter will be used for hysterosalpingography
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • women with pelvic inflammatory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032642

Locations
Egypt
kasr Al-Aini hospital
Cairo, Egypt, 11451
Sponsors and Collaborators
Kasr El Aini Hospital
The Egyptian IVF-ET Center
Investigators
Principal Investigator: ragaa mansour, PhD Egyptian IVF-ET center
Study Director: hesham Al-Inany, PhD Kasr Al-Aini Hospital
  More Information

No publications provided

Responsible Party: Ragaa Mansour, The Egyptian IVF-ET center
ClinicalTrials.gov Identifier: NCT01032642     History of Changes
Other Study ID Numbers: Inany-1
Study First Received: December 11, 2009
Last Updated: December 15, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Kasr El Aini Hospital:
infertility fallopian tubes

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013