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A Thin Catheter For Hystrosalpingography (HSG)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
device for hysterosalpingography
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring infertility fallopian tubes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • women with pelvic inflammatory disease

Sites / Locations

  • kasr Al-Aini hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thin catheter group

Arm Description

group of women where thin catheter will be used for hysterosalpingography

Outcomes

Primary Outcome Measures

pain score during introduction of catheter and during the injection of dye
the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes

Secondary Outcome Measures

adverse events

Full Information

First Posted
December 11, 2009
Last Updated
December 15, 2009
Sponsor
Kasr El Aini Hospital
Collaborators
The Egyptian IVF-ET Center
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1. Study Identification

Unique Protocol Identification Number
NCT01032642
Brief Title
A Thin Catheter For Hystrosalpingography
Acronym
HSG
Official Title
A Simple Technique to Reduce the Pain in Hysterosalpingography Using A Thin Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kasr El Aini Hospital
Collaborators
The Egyptian IVF-ET Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility fallopian tubes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thin catheter group
Arm Type
Experimental
Arm Description
group of women where thin catheter will be used for hysterosalpingography
Intervention Type
Device
Intervention Name(s)
device for hysterosalpingography
Intervention Description
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 Measure Information:
Title
pain score during introduction of catheter and during the injection of dye
Time Frame
3-6 month
Title
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 Measure Information:
Title
adverse events
Time Frame
within the study period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women during their fertility workup and requesting to do hysterosalpingography Exclusion Criteria: women with pelvic inflammatory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ragaa mansour, PhD
Organizational Affiliation
Egyptian IVF Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
hesham Al-Inany, PhD
Organizational Affiliation
Kasr Al-Aini Hospital
Official's Role
Study Director
Facility Information:
Facility Name
kasr Al-Aini hospital
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

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A Thin Catheter For Hystrosalpingography

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