A Thin Catheter For Hystrosalpingography

NCT01032642 | Completed

• 1 other identifier: Inany-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

infertility fallopian tubes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• adverse events

  within the study period

Study Arms (1)

thin catheter group

EXPERIMENTAL

group of women where thin catheter will be used for hysterosalpingography

Device: device for hysterosalpingography

Interventions

device for hysterosalpingography DEVICE

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.

thin catheter group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• women with pelvic inflammatory disease

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• The Egyptian IVF-ET Center: collaborator

Study Sites (1)

kasr Al-Aini hospital

Cairo, Cairo Governorate, 11451, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Hysterosalpingography

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological

Study Officials

• ragaa mansour, PhD

  Egyptian IVF Center

  PRINCIPAL INVESTIGATOR

• hesham Al-Inany, PhD

  Kasr Al-Aini Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 16, 2009

Record last verified: 2008-09

Locations

EG (1)