A Thin Catheter For Hystrosalpingography (HSG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032642
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 16, 2009
The Egyptian IVF-ET Center
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Infertility Device: device for hysterosalpingography Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Simple Technique to Reduce the Pain in Hysterosalpingography Using A Thin Catheter
Study Start Date : September 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. pain score during introduction of catheter and during the injection of dye [ Time Frame: 3-6 month ]
  2. the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes [ Time Frame: 3-6 month ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: within the study period ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • women with pelvic inflammatory disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032642

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

Responsible Party: Ragaa Mansour, The Egyptian IVF-ET center Identifier: NCT01032642     History of Changes
Other Study ID Numbers: Inany-1
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: September 2008

Keywords provided by Kasr El Aini Hospital:
infertility fallopian tubes

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