Clinical trial NCT01032642: A Thin Catheter For Hystrosalpingography
Official title: A Simple Technique to Reduce the Pain in Hysterosalpingography Using A Thin Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: infertility fallopian tubes
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
Collaborators: name: The Egyptian IVF-ET Center
First posted: 2009-12-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* women with pelvic inflammatory disease

Primary outcomes:
measure: pain score during introduction of catheter and during the injection of dye
timeFrame: 3-6 month
measure: the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes
timeFrame: 3-6 month
Secondary outcomes:
measure: adverse events
timeFrame: within the study period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: kasr Al-Aini hospital
Study officials:
affiliation: Egyptian IVF Center
name: ragaa mansour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr Al-Aini Hospital
name: hesham Al-Inany, PhD
role: STUDY_DIRECTOR
References: